Remotely delivered information, training and support for informal caregivers of people with dementia

Eduardo González-Fraile; Javier Ballesteros; José-Ramón Rueda; Borja Santos-Zorrozúa; Ivan Solà; Jenny McCleery

doi:10.1002/14651858.CD006440.pub3

. 2021 Jan 4;2021(1):CD006440. doi: 10.1002/14651858.CD006440.pub3

Remotely delivered information, training and support for informal caregivers of people with dementia

Eduardo González-Fraile ^1,^✉, Javier Ballesteros ², José-Ramón Rueda ³, Borja Santos-Zorrozúa ⁴, Ivan Solà ⁵, Jenny McCleery ⁶

Editor: Cochrane Dementia and Cognitive Improvement Group

PMCID: PMC8094510 PMID: 33417236

Abstract

Background

Many people with dementia are cared for at home by unpaid informal caregivers, usually family members. Caregivers may experience a range of physical, emotional, financial and social harms, which are often described collectively as caregiver burden. The degree of burden experienced is associated with characteristics of the caregiver, such as gender, and characteristics of the person with dementia, such as dementia stage, and the presence of behavioural problems or neuropsychiatric disturbances. It is a strong predictor of admission to residential care for people with dementia.

Psychoeducational interventions might prevent or reduce caregiver burden. Overall, they are intended to improve caregivers' knowledge about the disease and its care; to increase caregivers' sense of competence and their ability to cope with difficult situations; to relieve feelings of isolation and allow caregivers to attend to their own emotional and physical needs. These interventions are heterogeneous, varying in their theoretical framework, components, and delivery formats. Interventions that are delivered remotely, using printed materials, telephone or video technologies, may be particularly suitable for caregivers who have difficulty accessing face‐to‐face services because of their own health problems, poor access to transport, or absence of substitute care. During the COVID‐19 pandemic, containment measures in many countries required people to be isolated in their homes, including people with dementia and their family carers. In such circumstances, there is no alternative to remote delivery of interventions.

Objectives

To assess the efficacy and acceptability of remotely delivered interventions aiming to reduce burden and improve mood and quality of life of informal caregivers of people with dementia.

Search methods

We searched the Specialised Register of the Cochrane Dementia and Cognitive Improvement Group, MEDLINE, Embase and four other databases, as well as two international trials registries, on 10 April 2020. We also examined the bibliographies of relevant review papers and published trials.

Selection criteria

We included only randomised controlled trials that assessed the remote delivery of structured interventions for informal caregivers who were providing care for people with dementia living at home. Caregivers had to be unpaid adults (relatives or members of the person's community). The interventions could be delivered using printed materials, the telephone, the Internet or a mixture of these, but could not involve any face‐to‐face contact with professionals. We categorised intervention components as information, training or support. Information interventions included two key elements: (i) they provided standardised information, and (ii) the caregiver played a passive role. Support interventions promoted interaction with other people (professionals or peers). Training interventions trained caregivers in practical skills to manage care. We excluded interventions that were primarily individual psychotherapy.

Our primary outcomes were caregiver burden, mood, health‐related quality of life and dropout for any reason. Secondary outcomes were caregiver knowledge and skills, use of health and social care resources, admission of the person with dementia to institutional care, and quality of life of the person with dementia.

Data collection and analysis

Study selection, data extraction and assessment of the risk of bias in included studies were done independently by two review authors. We used the Template for Intervention Description and Replication (TIDieR) to describe the interventions. We conducted meta‐analyses using a random‐effects model to derive estimates of effect size. We used GRADE methods to describe our degree of certainty about effect estimates.

Main results

We included 26 studies in this review (2367 participants). We compared (1) interventions involving training, support or both, with or without information (experimental interventions) with usual treatment, waiting list or attention control (12 studies, 944 participants); and (2) the same experimental interventions with provision of information alone (14 studies, 1423 participants).

We downgraded evidence for study limitations and, for some outcomes, for inconsistency between studies. There was a frequent risk of bias from self‐rating of subjective outcomes by participants who were not blind to the intervention. Randomisation methods were not always well‐reported and there was potential for attrition bias in some studies. Therefore, all evidence was of moderate or low certainty.

In the comparison of experimental interventions with usual treatment, waiting list or attention control, we found that the experimental interventions probably have little or no effect on caregiver burden (nine studies, 597 participants; standardised mean difference (SMD) ‐0.06, 95% confidence interval (CI) ‐0.35 to 0.23); depressive symptoms (eight studies, 638 participants; SMD ‐0.05, 95% CI ‐0.22 to 0.12); or health‐related quality of life (two studies, 311 participants; SMD 0.10, 95% CI ‐0.13 to 0.32). The experimental interventions probably result in little or no difference in dropout for any reason (eight studies, 661 participants; risk ratio (RR) 1.15, 95% CI 0.87 to 1.53).

In the comparison of experimental interventions with a control condition of information alone, we found that experimental interventions may result in a slight reduction in caregiver burden (nine studies, 650 participants; SMD ‐0.24, 95% CI ‐0.51 to 0.04); probably result in a slight improvement in depressive symptoms (11 studies, 1100 participants; SMD ‐0.25, 95% CI ‐0.43 to ‐0.06); may result in little or no difference in caregiver health‐related quality of life (two studies, 257 participants; SMD ‐0.03, 95% CI ‐0.28 to 0.21); and probably result in an increase in dropouts for any reason (12 studies, 1266 participants; RR 1.51, 95% CI 1.04 to 2.20).

Authors' conclusions

Remotely delivered interventions including support, training or both, with or without information, may slightly reduce caregiver burden and improve caregiver depressive symptoms when compared with provision of information alone, but not when compared with usual treatment, waiting list or attention control. They seem to make little or no difference to health‐related quality of life. Caregivers receiving training or support were more likely than those receiving information alone to drop out of the studies, which might limit applicability. The efficacy of these interventions may depend on the nature and availability of usual services in the study settings.

Plain language summary

Remotely delivered information, training and support for informal caregivers of people with dementia

Review questions

We were interested in remotely delivered interventions involving information, training and support for family caregivers of people with dementia. By remotely delivered, we meant that they were provided over the telephone or on a computer or mobile electronic device. We asked whether these kinds of intervention helped caregivers more than doing nothing, and also whether interventions that included elements of training and support worked better than simple provision of information about dementia.

Background

Caring for a family member or friend with dementia can offer positive experiences, but often also has negative consequences for the caregiver. These negative consequences may be emotional, physical, social and financial, and are sometimes described as caregiver 'burden.' Many interventions have been developed to try to help caregivers in their caring role. Often, these interventions involve several components. In this review we divided the intervention components into information (increasing caregivers' knowledge about dementia), training (helping them to practice important skills for successful caring) and support (providing an opportunity to share experiences and feelings with other people). We chose to review only interventions delivered remotely, in part because we were writing during the COVID‐19 pandemic, when many countries required people to remain in their homes. However, remotely delivered interventions may also be useful in many other kinds of situations when it is difficult for caregivers to access services in person.

Study characteristics

We searched up to April 2020 for randomised controlled trials that addressed our review questions. We found 12 studies with 944 participants that compared groups of caregivers receiving usual care, or some non‐specific contact with researchers, with other groups receiving remotely delivered interventions that involved information with training, support or both. We found another 14 studies with 1423 participants that compared simple information provision with more complex interventions that involved training or support. The interventions lasted an average of 16 weeks. Three studies took place in China; all the others were from North America or Europe. About half used the telephone and about half used the Internet to deliver the interventions.

What are the main results of our review?

Compared with the usual services provided for caregivers where the studies took place, or with non‐specific contact with the researchers, we found that the information, training and support interventions probably had no important effect on caregivers' overall burden, depressive symptoms, or quality of life. Caregivers in both groups may have been equally likely to drop out of the studies for any reason. Compared to information only, interventions which included training and support may result in a slight reduction of caregiver burden, probably reduce depressive symptoms, may have little or no effect on quality of life, and probably make it more likely that caregivers drop out of the studies. We did not find any obvious effects of different intervention components, but we were not able to draw any firm conclusions about this. There was no evidence on whether the interventions improved the quality of life of the people with dementia who were being cared for. We did not find any studies that reported harmful effects of the interventions or the additional burden they might add to the caregiver's life. We do not know how the interventions would perform in countries where few health and social care services are available for people with dementia and their families, or in situations where caregivers are unable to access usual services.

How reliable are these results?

We found that most studies were well‐conducted, but because most outcomes were subjective, there was a risk that the expectations of the caregivers and researchers could have influenced results. For some outcomes, there were inconsistent results among studies. Overall, our confidence in our findings was moderate or low so the results could be affected by further research.

Summary of findings

Background

Description of the condition

It is estimated that worldwide, about 50 million people have dementia, and there are nearly 10 million new cases every year (WHO 2020). Many people with dementia are being cared for at home by an unpaid informal caregiver, who is usually a female family member, often a spouse or daughter. It is estimated that family caregivers spend five to 20 hours per day and an average of 60 hours per week caring for the person living with dementia (Marziali 2006).

As a consequence of their role as caregiver of a person with a progressive and irreversible disease, the informal caregiver may experience a range of physical, emotional, financial and social harms (Collins 2011). This situation has been widely described in the literature and is known as caregiver burden (Dillehay 1990; George 1986). Caregiver burden is associated with characteristics of the caregiver, such as gender, and characteristics of the person with dementia, such as behavioural problems, stage of dementia and the presence of neuropsychiatric disturbances (Haley 2004). It is a strong predictor of a move from home care to residential care for people with dementia (Eska 2013).

Description of the intervention

A variety of psychosocial interventions have been suggested to prevent or to reduce the negative consequences of dementia care on informal caregivers (Cooke 2001; Etters 2008; Pusey 2001; Selwood 2007). The interventions are generally heterogeneous regarding (i) their theoretical framework, (ii) the focus and the type of interventions reported (e.g. behavioural intervention, stress management, education about the disease), and (iii) the administration format (group or individual, generic or tailored to specific needs, telephone‐ or Internet‐based).

Interventions that are delivered remotely using written materials, the telephone or Internet may be particularly suitable for caregivers of people with dementia who can struggle to access face‐to‐face services because of their own health problems, poor access to transport, or difficulties finding substitute care. At the time of writing, measures used by many countries to contain the COVID‐19 pandemic require that most people, including people with dementia and their family carers, are confined to their homes, isolating themselves from direct contact with others. In such circumstances, there is no alternative to remote delivery of interventions.

There are also, however, significant barriers to remote delivery of interventions, particularly for older caregivers. They may have sensory impairments or other disabilities that make use of the necessary technologies difficult. They may also lack confidence with the technologies involved and may particularly value direct contact with others, being less familiar than many younger people with the experience of finding support in online communities.

This review assesses the efficacy and acceptability of remotely delivered interventions that aim to offer information, training and support, or a mixture of these, to informal carers of people with dementia.

Information

We considered information interventions to have two key elements: (i) they involve the provision of standardised information whose contents are determined by the professional; and (ii) the participant has a passive role (i.e. there is no interaction with the professional or active practice of skills). The intervention can address various aspects: issues related to the person with dementia (e.g. signs and symptoms, natural history, treatments and care alternatives), their care (e.g. activities of daily living, nutrition, communication with the person with dementia), the difficulties derived from their care (behavioural problems, role incompatibility, use of drugs, sleep disturbances), or resources available in the community (Gallagher‐Thompson 2010). The format of implementation can vary: leaflets, manuals, lectures or audio‐visual presentations. The nature of these interventions makes them relatively easy to deliver remotely.

Training

The key element of training interventions is to provide caregivers with the practical skills to manage the burden of care. Caregivers will play an active role in the program (e.g. through supervised practice, or role playing). The training may relate to the care of the person with dementia (e.g. recognising behavioural triggers, communicating more effectively, tailoring tasks to patients' capabilities) or to management of the caregiver's psychological stress. Training can be classified into the following categories: (i) meeting patients' basic care needs, (ii) managing behavioural problems, and (iii) managing and coping with caregiver stress (Losada Baltar 2004; Martin‐Carrasco 2014). Delivery of these elements remotely is likely to be more challenging than the simple provision of information.

Support

The key element of support interventions is the participants' active role in discussing and sharing feelings, problems or issues related to care with other caregivers and professionals (Winter 2006). This category could include two types of support: (i) peer support (e.g. participation in a caregivers' group that is not professionally facilitated), and (ii) professional support (e.g. receiving counselling from a health professional) (Mittelman 2004). Peer support groups, in particular, are usually face‐to‐face, but as technologies develop, it is increasingly possible for these to take place online.

How the intervention might work

Interventions for caregivers of people with dementia may work in a variety of ways depending on the content. Broadly speaking, they are intended to improve caregivers' knowledge about the disease and its care (Ducharme 2011; Liddle 2012); to increase their sense of competence (Laakkonen 2012) and their ability to cope with difficult situations (e.g. behavioural disturbances, communication problems) (Cheng 2012); and to relieve feelings of isolation, as well as to allow caregivers to attend to their own emotional and physical needs (Roth 2009).

Why it is important to do this review

Throughout the world, the majority of care for people with dementia is provided by family members. Anything that can be done to ease the burden of this care will be good for the caregivers and for the people they care for. It may also ease the burden on health and social care systems, for example by improving caregivers' health and by delaying institutional care for the person with dementia. All health and care systems are struggling with the magnitude of the problem presented by dementia. Remote delivery of interventions to support caregivers, if acceptable and effective, offers the opportunity to reach more people than conventional services, potentially at lower cost.

Development of remotely delivered interventions acquired a new urgency in the context of the COVID‐19 pandemic. The strain on family caregivers who are isolated with a person with dementia is hugely magnified. Not only are they cut off from their usual community and professional supports, but so is the person with dementia, whose behaviour may be more challenging as a result. Because of their age and vulnerability, these groups may experience more prolonged periods of isolation than other members of the community. Identification of effective interventions for caregivers that can be delivered remotely is needed more than ever.

This review aims to collate the best evidence about the efficacy and acceptability of these interventions to facilitate decision‐making by those designing, delivering and receiving services.

Objectives

To assess the efficacy and acceptability of remotely delivered interventions aiming to reduce the burden and improve the mood and quality of life (QoL) of informal caregivers of people with dementia.

Methods

Criteria for considering studies for this review

Types of studies

We included randomised controlled trials (RCTs) in which caregivers were randomly assigned to remotely delivered psychoeducational interventions that included information with support or training, or to a control condition. The control condition could be simple provision of information or waiting list, usual care or a non‐specific intervention serving as an attention control.

We excluded all non‐randomised studies and also RCTs with a cross‐over design, due to the high risk of carryover effects.

Types of participants

Eligible trials included informal caregivers of people with dementia receiving care at home. The dementia of the cared‐for person could be of any type. We accepted clinical diagnoses or diagnoses reached using formal diagnostic criteria such as the Diagnostic and Statistical Manual of Mental Disorders (DSM), the International Classification of Diseases (ICD), the National Institute on Aging ‐ Alzheimer's Association (NIA‐AA) or the Alzheimer's criteria of the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS‐ADRDA). Caregivers had to be unpaid adults (relatives, or members of the person's community; 18 years of age or older), of either sex, and of any ethnic or geographical origin. Studies that included caregivers of people with mixed diagnoses were included only if data on caregivers of people with dementia could be extracted separately.

Types of interventions

We included trials that assessed remote delivery of structured interventions involving training, support, information provision, or combinations of these elements, and that only targeted informal caregivers. We considered an intervention to be structured if there was a clear description of a standard set of components and how they were implemented. They could be delivered using paper, the telephone, the Internet or a mixture of these, but did not involve any face‐to‐face contact with professionals or other caregivers. These interventions had to be compared with a control condition, which could be provision of information alone or a waiting list, usual care or any non‐specific intervention serving as an attention control. Participants in waiting list groups were offered the experimental interventions once the study finished. Participants in attention control groups received a similar amount of contact with professionals to those in the experimental group, but the content of the contact involved no specific information, training or support related to dementia.

The following interventions were excluded:

interventions aimed at healthcare professionals;
interventions aimed at the people with dementia;
respite care interventions;
interventions for caregivers that are individually tailored and whose components are not well defined; and
interventions for caregivers that are predominantly psychotherapy, including interventions based entirely on the cognitive behavioural model (CBT). However, interventions that included elements of CBT as part of a larger, multimodal intervention were eligible for inclusion.

We used the following criteria to identify information, support and training. Information interventions include two key elements: (i) they provide standardised information, and (ii) the caregiver plays a passive role. Support interventions promote caregiver interaction with other people (professionals or peers). Training interventions are structured interventions intended to train caregivers in practical skills in order to prevent or alleviate the negative consequences of care giving.

We used the following operational criteria to categorise the interventions:

Intervention	Definition	Key elements
Information	Structured programmes with standardised information about issues related to care of people with dementia and caregiver burden. The contents of the intervention can include issues related to: Manifestation of dementia (e.g. signs and symptoms, natural history, treatments and care alternatives). Care of the people with dementia (e.g. activities of daily living, nutrition, communication with the person with dementia). Difficulties associated with their care (e.g. managing behavioural problems, role incompatibilities, use of drugs, sleep disturbances), or resources available in the community.	The intervention involves the provision of standardised information whose contents are determined by a professional in charge of the dementia. The participant has a passive role, and there is no interaction with the professional or active learning and practice of appropriate skills.
Support	Programmes that allow the caregiver to talk, discuss or share information about their caregiver issues. There are two types of support: Peer support (e.g. participating in a caregivers' group that is not professionally facilitated). Professional support (e.g. having counselling from a health professional).	The participant has an interactive role talking, discussing or sharing their feelings, problems or contents related to the care provided with other caregivers or professionals.
Training	Structured interventions intended to empower caregivers with practical skills to manage the issues related to care. The skills to be acquired may relate to the care of the person with dementia, or to the management of the caregiver's psychological stress, according to the following categories: Fulfilling basic care needs. Management of behavioural problems. Stress management and coping style.	Caregivers play an active role (e.g. through supervised practice, role playing, etc.) in the intervention provided.

Study	Au 2015
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Psychoeducation with behavioral activation (PsyED‐BA).	Psychoeducation only (PsyED).
WHY	Based on the Gallagher‐Thompson’s program Coping with Cargiving. The aim is to enhance the use of coping skills via behavioral activation (BA), since it would be more acceptable and helpful than change dysfunctional thoughts, overcome barriers to treatment access and train paraprofessionals to deliver some modules of the program.	General discussion about the psychoeducation program and information packet.
WHAT materials	Caregivers were given a printed copy of the psychoeducation program (adapted from the Chinese version of the Coping with Caregiving manual) together with an information packet with fact sheets concerning local organizations, community resources, and social and mental issues related to dementia. 1.‐ Patient‐Change Workshop, Procedures Manual, Progress Notes, Problem Behavior Tracking forms, written cueing systems for repetitive verbal behavior, audio/videotape or tactile diversion program for repetitive vocal and physical behaviours, and verbal and physical prompting procedures for continence and self‐feeding problems, Caregiver Self‐Change Recording Form. 2.‐ Self‐change Workshop, Problem Behavior Tracking forms, Caregiver‐self change recording form.	Caregivers were given a printed copy of the psychoeducation program (adapted from the Chinese version of the Coping with Caregiving manual) together with an information packet with fact sheets concerning local organizations, community resources, and social and mental issues related to dementia.
PROCEDURES	Participants were contacted by telephone within the same week of the baseline assessment to start the psychoeducation program. There were a total of four weekly intervention telephone calls, each lasting about 30 minutes. ‐ In the first week, all participants were taught about the symptoms and associated behavioral changes of dementia and the possible effects on the caregivers. Participants were also invited to share their caregiving experiences. ‐ In the second week, participants learned about the physical, social, and psychological consequences of stress and being aware of their own stress. They were invited to talk about their own stress. ‐ In the third week, they learned about the principles of identifying and scheduling pleasant events for themselves. ‐ In the fourth week, participants learned about communication: communicating their own needs to seek support from their family members. They also learned about the characteristics of various different types of communications: passive, aggressive, and assertive. Participants had eight biweekly telephone sessions over the following 4 months. Each session consisted of a telephone call lasting 15 to 20 minutes. The first four sessions focused on pleasant event scheduling and the other four sessions on effective communication. The tasks involved in each of the four sessions were as follows: 1. Activity monitoring: how is the participant spending time/ communicating now? 2. Activity scheduling: schedule pleasant event/effective communications 3. Reinforcing or modifying the pleasant event and communication based on feedback or self‐evaluation 4. Activity rescheduling/revision based on changes after modification. Finally, social work services were available upon requests in outpatient departments in which the care recipients received their regular follow‐up.	Participants were contacted by telephone within the same week of the baseline assessment to start the psychoeducation program. There were a total of four weekly intervention telephone calls, each lasting about 30 minutes. Participants had eight biweekly telephone sessions over the following 4 months. Each session consisted of a telephone call lasting 15 to 20 minutes: ‐ Participants were asked to go through the materials of the psychoeducation program and the information package. For each of the telephone session, the participants were asked to select their own topics for general discussion. If the caregiver selected pleasant event scheduling or communications, general discussion would be carried out without any BA procedures. Finally, social work services were available upon requests in outpatient departments in which the care recipients received their regular follow‐up.
WHO provided	Five paraprofessionals recruited trained to administer BA procedures. They were between 55 and 60 years old and had previously completed post‐secondary school training in areas related to human services (i.e., nursing or management). They had subsequently completed a 42‐hour course on Introduction to Psychology and had then received 20 hours of group training led by a social worker and a clinical psychologist (the principal investigator of the study) on BA in the context of the Copy with Caregiving program. Each paraprofessional worker was tested on a mock case before delivering the program to actual caregivers. Ongoing weekly supervision was provided by the clinical psychologist and social worker.
HOW delivered	Individually over the telephone.
WHERE occurred	At home.
WHEN and HOW MUCH	Twelve sessions: sessions 1 to 4 were delivered weekly, sessions 5 to 12 were delivered biweekly. Each session consisted of a telephone call lasting 15 to 20 minutes.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	No described.

Study	Au 2019
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Psychoeducation with behavioral activation (TBA).	General Monitoring (TMG).
WHY	Behavioral activation (BA) focuses on constructing reinforcement contingencies that increase functional behavior and self‐efficacy. Self‐efficacy refers to the person’s beliefs about the abilities to exercise control on the events affecting their lives. The intervention was adapted from the Chinese Version of the Coping with Caregiving.	General discussion about the psychoeducation program and information packet.
WHAT materials	Written information, including the forms for pleasant event scheduling, was mailed to participants before the program started.	Information packet.
PROCEDURES	Four weekly sessions of psychoeducation and eight sessions of behavioral activation. Themes of the psychoeducation component were as follows. Session 1 (week 1): · Symptoms and associated behavioral changes in dementia · Stages in dementia · Caregiving roles and demands · Effects on caregivers Session 2 (week 2): · Physical, social and psychological consequence of stress · Identifying stress reactions · Awareness of stress · Stress and well‐being Session 3 (week 3): · The effect of life events on mood · Tracking daily/ weekly events · Identifying pleasant events · Scheduling pleasant events Session 4 (week 4): · Communication needs to family members · Types of communications: passive, aggressive and assertive · Resources available in the community · Planning in the future Themes of the behavioral activation component were: · Session 1 – Review the present use of time. Using the monitoring form · Session 2 – Brain‐storm pleasant events. Scheduling pleasant activities · Session 3 – Review scheduling of events. Discuss how to improve · Session 4 – Review modifications. Consolidate gains on scheduling · Session 5 – Review present social support. Explore new sources of support · Session 6 – Examine communication skills. Explore new options · Session 7 – Review new communications. Discuss how to improve · Session 8 – Review modification. Consolidate gains on support	All TGM participants received four weekly psycho‐education sessions over the phone with the same contents as in the TBA group. These caregivers were then assigned to eight bi‐weekly sessions of general monitoring with no BA intervention. Each of these sessions started with checking in with the caregiver through inviting them to update their caregiving situation. Caregivers were then guided to discuss one of the following topics at each session in this order: 1. caregiver’s health 2. care‐recipient’s needs 3. caregiver’s routines 4. social support. As there were a total of eight sessions, the last four sessions repeated the order of the first four. While some caregivers might report on attempts they made on their own initiative to improve their scheduling and communication, no specific attempt was made to ask them to review these attempts.
WHO provided	An interventionist with a degree in social work delivered all the four sessions of psycho‐education. Six paraprofessional coaches, between 50 and 60 years old and with an undergraduate degree in helping or service professions, delivered the BA or MG interventions, or carried out monitoring. A social worker and a clinical psychologist provided the training and facilitated weekly supervision separately for TBA and TGM coaches.
HOW delivered	Individually over the telephone.
WHERE occurred	At home.
WHEN and HOW MUCH	Twelve sessions: sessions 1 to 4 were delivered weekly and sessions 5 to 12 were delivered biweekly. Each session lasted about 20 minutes.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	The program fidelity was assessed by a rating system built into recording form. At the end of each session, all interventionists, including the paraprofessionals, were asked to rate to what extent they were able to follow the protocol for each of the four PE sessions (3 = fully; 2 = adequately with at least 60% of the material covered; 1 = slightly; 0 = not at all). A similar procedure was adopted for each of the 8 sessions for both TBA and TGM. In addition, 10 cases from TBA and 10 cases from TGM were audiotaped. Interventionists’ adherence to the intervention protocol was assessed by two graduate students who had received eight hours of training on the coding scheme. The sessions were coded with reference to four core TBA strategies (activity planning, review to improve on scheduling, develop new help‐seeking communication skills and review to improve on communications) and four core TGM strategies (updating on caregiving situation, health and needs of the caregiver and the care‐recipient, daily routines and family communications).
HOW WELL actual	As planned. Minimal deviations to the main components of the intervention.

Study	Blom 2015
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Mastery of dementia (MoD).	Minimal Intervention (e‐bulletins).
WHY	A guided self‐help Internet course ‘Mastery over Dementia’ (MoD) designed to reduce caregivers’ symptoms of depression and anxiety. MoD included a combination of psycho‐education with active participation of the caregiver, management of behavioral problems, teaching coping strategies, components of cognitive behavioral therapy (cognitive reframing: changing non‐helpful into helpful thoughts), and increasing social support.	No applicable.
WHAT materials	Internet contents.	E‐bulletins (digital newsletters).
PROCEDURES	The Internet course consists of 8 lessons and a booster session with the guidance of a coach monitoring the progress of participants and evaluating the homework. Each lesson has the same structure and consists of information (text material and videos), exercises, and homework, with an evaluation at the start and end of each session. The elements of the course were presented in the following order: · coping with behavioral problems (problem solving) · relaxation · arranging help from others · changing non‐helping thoughts into helping thoughts (cognitive restructuring) · communication with others (assertiveness training). The booster session was provided a month after participants finished the eight lessons, and provided a summary of what was learned. After every lesson, participants sent their homework to a coach via a secure application. The coach sent electronic feedback to caregivers on their homework within three working days. The feedback had to be opened before the next lesson could be started. Participants were automatically reminded to start with a new lesson or to send in their homework if they were not active for a fixed period of time. All participants in this study received feedback from the same coach, a psychologist employed by a health care agency with additional training in cognitive behavioral therapy and experience in the field of dementia.	Caregivers received a minimal intervention consisting of e‐bulletins (digital newsletters) with practical information on providing care for someone with dementia. The bulletins were sent by email according to a fixed schedule (every 3 weeks) over nearly 6 months. The topics of the bulletin, which did not overlap with the content of MoD, were: · driving · holiday breaks · medication · legal affairs · activities throughout the day · help with daily routines · grieving · safety measures in the home · possibilities for peer support. There was no contact with a coach over the length of the study.
WHO provided	Internet intervention. A coach monitored the progression of the participants.	No applicable.
HOW delivered	Online.
WHERE occurred	At home.
WHEN and HOW MUCH	Eight lessons plus a booster session.	The bulletins were sent by email according to a fixed schedule (every 3 weeks) over nearly 6 months.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	No described.

Study	Brennan 1995
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	ComputerLink.	None beyond general information to identify local resources.
WHY	The intervention aimed to help caregivers develop problem‐solving skills, manage their own emotions, and increase their knowledge of dementia and caregiver‐support strategies.	No applicable.
WHAT materials	Caregivers received a Wyse 30 terminal and a Everex modem system.	No applicable.
PROCEDURES	ComputerLink provided three functions: · information · decision support · communication The electronic Encyclopedia provided extensive factual information to enhance self‐care and understanding of Alzheimer’s disease and promote health management of the care recipient. The program uses a system to help caregivers to resolve problems basing in the multiattribute utility theory of von Winterfeldt & Edwards. ComputerLink permitted several options for communication among caregivers, including private mail, access to a public bulletin board, and a section of questions and answers. A nurse moderator entered the system daily and read and responded to messages. The nurse served as a moderator and facilitator.	None beyond general information to identify local resources.
WHO provided	Study nurses who had completed an intervention training programme.	No applicable.
HOW delivered	Online.	No applicable.
WHERE occurred	At home.	No applicable.
WHEN and HOW MUCH	Participants had access to the system 24 hours a day during 12 months.	No applicable.
TAILORING	Intervention was comprehensively designed, not tailored to cover individual or unmeet needs.	No applicable.
MODIFICATIONS	None described.	No applicable.
HOW WELL planned	Indicators for logging in the system.	No applicable.
HOW WELL actual	Caregivers logged into the system 3,875 times, They accessed it a mean of 83 times over 12 months. A typical encounter lasted 13 minutes.	No applicable.

Study	Cristancho‐Lacroix 2015
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Diapason.	Treatment as usual.
WHY	The program’s content on the web was based on cognitive theories of stress.	No applicable.
WHAT materials	Web materials.	No applicable.
PROCEDURES	· Session 1: Caregiver stress – this session presents a definition of stress, its causes and consequences on caregivers, risk factors for chronic stress, and mechanisms and effects of relaxation (includes a link to the relaxation training in the Diapason website), as well as strategies for managing stress underlining the importance of looking for respite. · Session 2: Understanding the disease – in this session, the Alzheimer’s disease diagnosis procedure, the symptoms, the progression of the illness, and the consequences on daily life activities for persons with Alzheimer’s disease (PWAD) are explained. · Session 3: Maintaining the loved ones’ autonomy – this session presents the reasons and strategies to involve loved ones in the process of care in order to stimulate the preserved functions and compensate for the lost ones. The session underlines the importance of maintaining the self‐esteem of PWAD. · Session 4: Understanding their reactions – in this session, the most frequent behavioural and psychological symptoms of dementia (BPSD) and their characteristics are succinctly described and illustrated by examples from daily life. The contextual and intrinsic factors that might be associated with them are also described. · Session 5: Coping with behavioral and emotional troubles – this session presents practical advice on how to cope vis‐à‐vis the BPSD described in the previous session. · Session 6: Communicating with loved ones – this session includes the description of the most frequent language troubles and the strategies to modulate and adapt communication to the preserved skills of PWAD. · Session 7: Improving their daily lives – this session presents strategies to facilitate the performance of activities that become difficult or impossible to execute due to apraxia, illustrating them with examples adapted to daily life. · Session 8: Avoiding falls – the session includes practical advice for maintaining and stimulating the relative’s balance and actions to adopt in the event of a fall. In addition, various actions are described to adapt the relative’s home. · Session 9: Pharmacological and non‐pharmacological interventions – this session includes a brief presentation of different interventions available for caregivers in France with pharmacological treatment as well as cognitive and psychological support. · Session 10: Social and financial support – this session presents the different stakeholders and services that may help caregivers in their daily life. The financial and social support provided by the French government is also revised. · Session 11: About the future – this session provides caregivers with information about the role of disease progression anticipation, inviting them to try and foresee solutions keeping a prospective vision, encouraging them to look for further sources of information, and social support to reduce the uncertainty of caregiving situations. · Session 12: In a nutshell – the last session encompasses a summary of the Diapason program, emphasizing the acceptance of support and help and the importance of obtaining more information to anticipate and avoid stressful circumstances. Additionally the website contains other sections that can be consulted at any time: · Relaxation training: guidelines for learning relaxation as well as 2 videos for the modelling of Schultz’s Autogenic Training and Jacobson’s method. · Life Stories: stories about 4 couples, based on testimonials of caregivers, in which difficult situations are illustrated and possible solutions to manage them are discussed (i.e., apathy of patient, caregivers’ isolation). · Glossary: a glossary for technical words (i.e., neuropsychological assessment, aphasia). · Stimulation: practical activities to stimulate autonomy and share pleasant activities with the relatives in daily life. · Forum: a private and anonymous forum to interact with peers, to express their concerns, discuss solutions to daily problems, and share their feelings and experiences. The participants use nicknames to protect their privacy. A clinical psychologist participates in the discussions if necessary (i.e., avoiding aggressive or inappropriate comments).	No applicable.
WHO provided	No web‐moderate self‐provided intervention except when using the forum resource.	No applicable.
HOW delivered	Online.	No applicable.
WHERE occurred	Home.	No applicable.
WHEN and HOW MUCH	The length of the intervention was 3 months, with each weekly session lasting 15 to 30 minutes on average, but there was no time limit and the participants could access different website sections (i.e., relaxation training, forum) for as long as they wished at any time.	No applicable.
TAILORING	Intervention was comprehensively designed, not tailored to cover individual or unmeet needs.	No applicable.
MODIFICATIONS	None described.	No applicable.
HOW WELL planned	Indicators for login in the system.	No applicable.
HOW WELL actual	On average, participants used the website 19.7 times (SD 12.9) and for 262.2 minutes (SD 270.7) during the first 3 months.	No applicable.

Study	Czaja 2013
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Named "intervention condition".	Two control conditions which were combined: attention control and information
WHY	The intervention condition was modelled after the REACH II intervention.	No described.
WHAT materials	A videophone (CISCO IP 7900) was installed in the caregivers’ homes and connected to a Digital Subscriber Line and to a secure server at the host site. Participants in this condition also received a caregiver notebook with basic information about caregiving and community resources.	Caregivers in the attention condition were provided with a notebook with information related to nutrition. The information condition group received educational materials with basic information about dementia, safety, and community resources.
PROCEDURES	The intervention included education and skills training. It was designed to address five caregiver risk areas (safety, social support, problem behaviours, depression, and caregiver health). The intervention was standardized with respect to the treatment domains and strategies used within the treatment domains but individualized with respect to the amount of emphasis within a treatment domain based on a risk assessment administered at baseline. Certified interventionists taught problem solving strategies to deal with the care recipients’ problem behaviours and training on stress management, healthy behavior strategies, community resources, and communication strategies. The intervention included six 1‐hour monthly sessions. The four educational seminars were brief video lectures from experts on topics relevant to caregiving (i.e., update on Alzheimer disease, caregiver depression) and were presented serially; a new video appeared monthly beginning in month 2 of the intervention.The intervention also included five videophone support group sessions, which were interspersed throughout the intervention period. The support groups were structured and included up to six caregivers and a certified group leader. During the support group sessions caregivers received topical information (related to the material covered in the individual intervention sessions) and shared experiences and concerns.	Attention condition: participants received two 1‐hour in‐home sessions and four videophone sessions. They also participated in five telephone support group sessions, which were interspersed with the individual intervention sessions. The support groups followed the same format as those for the intervention group. The content for the attention control condition was structured around nutrition and healthy eating. Information condition: participants were mailed a packet of educational materials and received a brief (<15 minute) telephone “check‐in call” at 3 months post randomisation.
WHO provided	Interventionists. All assessors and interventionists received training and were certified before entering the field.
HOW delivered	Online plus telephone.	Face to face plus telephone.
WHERE occurred	At home.
WHEN and HOW MUCH	6 sessions (1 hour each).	· 6 sessions (1 hour each). · 15 minutes “check‐in‐call”.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	Interventionists submitted taped treatment sessions for review and feedback as part of the certification. Treatment implementation was monitored and maintained by weekly supervision meetings. Both interventionists and assessors followed a detailed manual of operations and a delivery assessment form was completed after each contact.
HOW WELL actual	No described.

Study	Davis 2004
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Telephone training or in‐home training (this review only includes evidence from telephone training).	Friendly, socially supportive, telephone calls.
WHY	The study was grounded in the stress, appraisal and coping theory of Lazarus. The premise for the caregivers skill training intervention was that improvements in caregiver's outcomes could be addressed by expanding caregiver's repertoire of effective appraisal and coping strategies through telephone training strategies	No applicable.
WHAT materials	Caregivers received a standardized, loose‐leaf notebook with suggestions for managing frequently encountered Alzheimer’s disease situations. They had to fill out a weekly log on problems they had managed over the past week.	Socially supportive friendly telephone calls.
PROCEDURES	Caregivers participated in training sessions focused on: · general problem solving · caragiver appraisal of behavior problems · written behavioral programs for managing specific problems · strategies for handling effective responses to difficult caregiving situations. They received an initial home visit of 45 minutes to introduce the trained interventionist and to familiarize with the uses of the notebook and log sheets. At each weekly contact, the interventionist reviewed the past week of caregiving problems with the caregiver, discussed the log entries and used selected notebook sections to help the caregiver manage the situation.	Friendly callers made an initial home visit of approximately 45 minutes to introduce themselves. At the time of each contact, callers required about the caregiver's past week as well as any changes in their general health and medication regimen.
WHO provided	Interventionists.
HOW delivered	Telephone.
WHERE occurred	At home.
WHEN and HOW MUCH	12 weekly telephone contacts.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	No described.
HOW WELL planned	Telephone contacts were tape recorded and reviewed to assess continued adherence.
HOW WELL actual	Telephone contacts averaged 37 minutes (SD=18)	Friendly telephone calls averaged 16 minutes (SD=12).

Study	Dowling 2014
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	LEAF (Life Enhancing Activities for Family Caregivers).	Attention control group.
WHY	The positive affect intervention teaches participants a series of behavioral and cognitive “skills” for increasing positive affect coping with health‐related and other life stresses. The skills include noticing and capitalizing on positive events, gratitude, mindfulness, positive reappraisal, focusing on personal strengths, attainable goals, and acts of kindness.	No described.
WHAT materials	No described.
PROCEDURES	Skill‐building Intervention Sessions · Session 1: Positive Events and Gratitude – Identify a positive or meaningful event in the last week and what it means to note, favour, and capitalize on positive events. Homework: write down 3 things that went well each day and why they went well. Begin a gratitude journal (writing one thing each day you are grateful for) that continued throughout the rest of the intervention. · Session 2: Mindfulness – Teach concepts of mindful attention and non‐judgment. Homework: (a) practice awareness of breathing and meditation for 10 minutes daily and (b) once a day take the time to enjoy something that you usually hurry through, do one thing at a time, and pay attention to it. Participants were encouraged to continue the breathing exercise through the remaining weeks of the intervention and to continue the gratitude journal. · Session 3: Positive Reappraisal – Discuss the meaning of positive reappraisal and how to apply it to everyday occurrences. Homework: each day think of one negative or stressful thing that happened. Practice positive reappraisal – why it may not be as bad as initially thought or something good that might come of it. Participants were encouraged to write about their experience reappraising at the end of each day and to continue their gratitude journal and mindful breathing exercises. · Session 4: Personal Strengths and Attainable Goal – Generate a list of personal strengths that can be used in everyday life. Define attainable goals and practice setting one related to self‐care. Homework: achieve attainable goal. Participants were encouraged to write about their goals at end of day and to continue their gratitude journal and mindful breathing exercises. · Session 5: Altruistic Behaviors/Acts of Kindness – Doing for Others – Discuss the positive impact of doing for others. Homework: do something nice for someone else each day. Participants were encouraged to write about their acts of kindness at end of day and to continue their gratitude journal and mindful breathing exercises.	Participants randomised to the control group engaged in 5 one‐on‐one sessions with a facilitator. The sessions were comparable in length to the intervention sessions (approximately 1 hour) but consisted of an interview and did not have any didactic portion or skills practice. Each session began with the completion of the modified Differential Emotions Scale (DES). In addition to these affect questions, each session had qualitative and quantitative questions and activities cantered on a theme (i.e., life history, health history, diet and exercise, social networks, and meaning and spirituality), to keep the sessions different and interesting for participants. Home practice for the control group consisted of the brief daily affect reports. At the start of sessions 2 through 6, the facilitator reviewed the previous week’s affect diary with the participant.
WHO provided	Facilitators for the intervention sessions were trained for content and delivery. Two were clinical nurse specialists in fronto‐temporal dementia and 1 was a psychologist.	The facilitator for the control group sessions was a research associate, familiar with the content of the intervention sessions so as to not engage in the intervention content during control sessions with participants.
HOW delivered	Mainly by video‐conference (only 1 subject participated in‐person, all others participated remotely).
WHERE occurred	At home.
WHEN and HOW MUCH	6 sessions of 1 hour each.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	All sessions were audio‐recorded digitally for both quality assurance and intervention evaluation.
HOW WELL actual	No described.

Study	Duggleby 2018
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	My Tools 4 Care (MT4C).	Information.
WHY	The aim of the intervention, based on transition theory, was to support carers through transitions and increase their self‐efficacy, hope, and health related quality of life. The intervention had multiple components and included choice, as the carers could choose which sections they would like use, and when. User‐generated content is encouraged throughout the intervention as participants may write in sections, add stories, pictures, music etc. Sections include: · About Me · Common Changes to Expect · Frequently Asked Questions and Resources · Important Health Information (about person they are caring for).	No applicable.
WHAT materials	An online version of the Toolkit entitled My Tools 4 Care (MT4C) (https://www.mytools4care.ca/).	A copy of the Alzheimer Society’s booklet The Progression of Alzheimer’s Disease, sent by email.
PROCEDURES	Participants received information for the MT4C website, (i.e., the website address, a unique username and password to access the site for 3 months), and an electronic copy of a Toolkit Checklist in which the participant will be asked to document their use of MT4C (i.e., time spent and content accessed over the 3 months). Participants also received an electronic copy of the Alzheimer Society’s educational booklet, The Progression of Alzheimer’s Disease.	The electronic document consists of a five‐part series that describes the stages of Alzheimer’s disease. It is written for the person with Alzheimer disease, their family and carers and is freely accessible via the Alzheimer Society of Canada website.
WHO provided	Whole intervention was over the Internet.	No applicable.
HOW delivered	Online	Emailed booklet.
WHERE occurred	At home.
WHEN and HOW MUCH	Intervention was accessible for 3 months.	No applicable.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.	No applicable.
HOW WELL planned	Webpage recorded the time and duration of access.	No applicable.
HOW WELL actual	73% of caregivers used MT4C at least once over the 3‐month period. By 3 months, participants spent most of their time on Section 2 – Common changes to expect (median 15 minutes) and Section 4 – Resources (median 10 minutes).	No applicable.

Study	Gant 2007
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Video/workbook/telephone coaching condition.	Education/check‐in‐call condition.
WHY	No described.
WHAT materials	Caregivers in the video condition received a 10‐session video series, a workbook from the Dementia Caregiving Skills Program, and weekly telephone calls from a trained coach.	Participants received by mail a 37‐page booklet, Basic Dementia Care Guide and phone calls.
PROCEDURES	The intervention used primarily behavioural strategies: behavioural activation, behavioural management, and stress reduction through relaxation training. The workbook provided didactic and experimental materials to reinforce information presented in each video session. Participants received 12 weekly phone calls by trained research staff who served as coaches. The first 10 calls reinforced each of the video sessions, the last 2 calls served as follow‐up for further application of concepts. Coaches followed a coach manual that provided a script for reviewing didactic materials and assignments with caregivers, and for assisting them in the application of intervention concepts to their problems. During the coaching calls caregivers reported the specific behavioural strategies that they devised, written down, used, and evaluated, based on the behaviour management module that they learned to apply to their situations.	Intervention included information on dementia and suggestions for dealing with a variety of caregiving challenges. In a cover letter, procedures for maximizing the benefits of this educational booklet were provided. Caregivers then received approximately 7 biweekly telephone calls by a trained staff member. In these calls, the staff member checked on the safety of the caregiver and family member, discussed the caregiver’s use of the suggestions from the guide, and responded to questions by referring the caregiver to appropriate sections in the guide. A standardized script was used for calls to participants in this comparison condition.
WHO provided	Coaches following a coach manual.
HOW delivered	By telephone.
WHERE occurred	At home.
WHEN and HOW MUCH	12 weekly telephone calls.	7 bi‐weekly telephone calls.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	No described.

Source	Search strategy	Hits retrieved
ALOIS (www.medicine.ox.ac.uk/alois) [Date of most recent search: 10 April 2020]	Advanced search: Study aim: Caregiver focused AND study design: RCT OR CCT OR Unclear	Dec 2015: 183 Jul 2016: 2 May 2017: 3 May 2018: 4 May 2019: 207
MEDLINE In‐process and other non‐indexed citations and MEDLINE 1950‐present (Ovid SP) [Date of most recent search: 10 April 2020]	1 Dementia/ 2 Delirium/ 3 Wernicke Encephalopathy/ 4 Delirium, Dementia, Amnestic, Cognitive Disorders/ 5 ("benign senescent forgetfulness" or ("normal pressure hydrocephalus" and "shunt") or ("organic brain disease" or "organic brain syndrome") or ((cerebral or cerebrovascular or cerebro‐vascular) adj2 insufficien) or (cerebr adj2 deteriorat) or (chronic adj2 (cerebrovascular or cerebro‐vascular)) or (creutzfeldt or jcd or cjd) or (lewy adj2 bod) or (pick adj2 disease) or alzheimer* or binswanger* or deliri* or dement* or huntington* or korsako).tw. 6 1 or 2 or 3 or 4 or 5 7 Caregivers/ 8 (caregiver or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kinship or parent* or relatives or spouse).tw. 9 7 or 8 10 Audiovisual aids/ 11 Books/ 12 Consumer Health Information/ 13 Health Education/ 14 Health Information Systems/ 15 Health Literacy/ 16 Health promotion/ 17 Information Dissemination/ 18 Pamphlets/ 19 Social Media/ 20 Telephone/ 21 ("Patient information" or "social media" or Audiovisual or Audio‐visual* or Book* or Leaflet* or Lecture* or Manuals).tw. 22 Education/ 23 Training Support/ 24 (Education or Train or Training).tw. 25 Community Networks/ 26 Homemaker Services/ 27 Respite Care/ 28 Self‐Help Groups/ 29 Social Support/ 30 ((caregiver* or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kin* or parent* or relatives or spouse) adj5 Support).tw. 31 (counsel or respite).tw. 32 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 33 6 and 9 and 32 34 (randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or drug therapy.fs. or randomly.ab. or trial.ab. or groups.ab. 35 33 and 34 36 dementia/ 37 delirium/ 38 Wernicke Encephalopathy/ 39 cognitive defect/ 40 ("benign senescent forgetfulness" or ("normal pressure hydrocephalus" and "shunt") or ("organic brain disease" or "organic brain syndrome") or ((cerebral or cerebrovascular or cerebro‐vascular) adj2 insufficien) or (cerebr adj2 deteriorat) or (chronic adj2 (cerebrovascular or cerebro‐vascular)) or (creutzfeldt or jcd or cjd) or (lewy adj2 bod) or (pick adj2 disease) or alzheimer* or binswanger* or deliri* or dement* or huntington* or korsako).tw. 41 36 or 37 or 38 or 39 or 40 42 Caregivers/ 43 (caregiver or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kinship or parent* or relatives or spouse).tw. 44 42 or 43 45 audiovisual aid/ 46 book/ 47 consumer health information/ 48 health education/ 49 medical information system/ 50 health literacy/ 51 health promotion/ 52 information dissemination/ 53 publication/ 54 social media/ 55 telephone/ 56 ("Patient information" or "social media" or Audiovisual or Audio‐visual* or Book* or Leaflet* or Lecture* or Manuals).tw. 57 education/ 58 (Education or Train or Training).tw. 59 community care/ 60 home care/ 61 respite care/ 62 self help/ 63 social support/ 64 ((caregiver* or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kin* or parent* or relatives or spouse) adj5 Support).tw. 65 (counsel or respite).tw. 66 45 or 46 or 47 or 48 or 49 or 50 or 51 or 52 or 53 or 54 or 55 or 56 or 57 or 58 or 59 or 60 or 61 or 62 or 63 or 64 or 65 67 randomized controlled trial/ 68 controlled clinical trial/ 69 random$.ti,ab. 70 randomization/ 71 intermethod comparison/ 72 placebo.ti,ab. 73 (compare or compared or comparison).ti. 74 ((evaluated or evaluate or evaluating or assessed or assess) and (compare or compared or comparing or comparison)).ab. 75 (open adj label).ti,ab. 76 ((double or single or doubly or singly) adj (blind or blinded or blindly)).ti,ab. 77 Double‐Blind Method/ 78 parallel group$1.ti,ab. 79 (crossover or cross over).ti,ab. 80 ((assign$ or match or matched or allocation) adj5 (alternate or group$1 or intervention$1 or patient$1 or subject$1 or participant$1)).ti,ab. 81 (assigned or allocated).ti,ab. 82 (controlled adj7 (study or design or trial)).ti,ab. 83 (volunteer or volunteers).ti,ab. 84 trial.ti. 85 66 or 67 or 68 or 69 or 70 or 71 or 72 or 73 or 74 or 75 or 76 or 77 or 78 or 79 or 80 or 81 or 82 or 83 or 84 86 41 and 44 and 66 and 85 87 (2015* or 2016).em. 88 86 and 87 89 Dementia/ 90 Delirium/ 91 Wernicke Encephalopathy/ 92 Delirium, Dementia, Amnestic, Cognitive Disorders/ 93 ("benign senescent forgetfulness" or ("normal pressure hydrocephalus" and "shunt") or ("organic brain disease" or "organic brain syndrome") or ((cerebral* or cerebrovascular or cerebro‐vascular) adj2 insufficien) or (cerebr adj2 deteriorat) or (chronic adj2 (cerebrovascular or cerebro‐vascular)) or (creutzfeldt or jcd or cjd) or (lewy adj2 bod) or (pick adj2 disease) or alzheimer* or binswanger* or deliri* or dement* or huntington* or korsako).tw. 94 89 or 90 or 91 or 92 or 93 95 Caregivers/ 96 (caregiver or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kinship or parent* or relatives or spouse).tw. 97 95 or 96 98 Audiovisual aids/ 99 Books/ 100 Consumer Health Information/ 101 Health Education/ 102 Health Information Systems/ 103 Health Literacy/ 104 Health promotion/ 105 Information Dissemination/ 106 Pamphlets/ 107 Social Media/ 108 Telephone/ 109 ("Patient information" or "social media" or Audiovisual or Audio‐visual* or Book* or Leaflet* or Lecture* or Manuals).tw. 110 Education/ 111 Training Support/ 112 (Education or Train or Training).tw. 113 Community Networks/ 114 Homemaker Services/ 115 Respite Care/ 116 Self‐Help Groups/ 117 Social Support/ 118 ((caregiver* or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kin* or parent* or relatives or spouse) adj5 Support).tw. 119 (counsel or respite).tw. 120 98 or 99 or 100 or 101 or 102 or 103 or 104 or 105 or 106 or 107 or 108 or 109 or 110 or 111 or 112 or 113 or 114 or 115 or 116 or 117 or 118 or 119 121 94 and 97 and 120 122 (randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or drug therapy.fs. or randomly.ab. or trial.ab. or groups.ab. 123 121 and 122	Dec 2015: 1282 Jul 2016: 166 May 2017: 159 May 2018: 169 May 2019: 164
Embase 1974‐2019 May 14 (Ovid SP) [Date of most recent search: 10 April 2020]	1 Dementia/ 2 Delirium/ 3 Wernicke Encephalopathy/ 4 Delirium, Dementia, Amnestic, Cognitive Disorders/ 5 ("benign senescent forgetfulness" or ("normal pressure hydrocephalus" and "shunt") or ("organic brain disease" or "organic brain syndrome") or ((cerebral or cerebrovascular or cerebro‐vascular) adj2 insufficien) or (cerebr adj2 deteriorat) or (chronic adj2 (cerebrovascular or cerebro‐vascular)) or (creutzfeldt or jcd or cjd) or (lewy adj2 bod) or (pick adj2 disease) or alzheimer* or binswanger* or deliri* or dement* or huntington* or korsako).tw. 6 1 or 2 or 3 or 4 or 5 7 Caregivers/ 8 (caregiver or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kinship or parent* or relatives or spouse).tw. 9 7 or 8 10 Audiovisual aids/ 11 Books/ 12 Consumer Health Information/ 13 Health Education/ 14 Health Information Systems/ 15 Health Literacy/ 16 Health promotion/ 17 Information Dissemination/ 18 Pamphlets/ 19 Social Media/ 20 Telephone/ 21 ("Patient information" or "social media" or Audiovisual or Audio‐visual* or Book* or Leaflet* or Lecture* or Manuals).tw. 22 Education/ 23 Training Support/ 24 (Education or Train or Training).tw. 25 Community Networks/ 26 Homemaker Services/ 27 Respite Care/ 28 Self‐Help Groups/ 29 Social Support/ 30 ((caregiver* or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kin* or parent* or relatives or spouse) adj5 Support).tw. 31 (counsel or respite).tw. 32 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 33 6 and 9 and 32 34 (randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or drug therapy.fs. or randomly.ab. or trial.ab. or groups.ab. 35 33 and 34 36 dementia/ 37 delirium/ 38 Wernicke Encephalopathy/ 39 cognitive defect/ 40 ("benign senescent forgetfulness" or ("normal pressure hydrocephalus" and "shunt") or ("organic brain disease" or "organic brain syndrome") or ((cerebral or cerebrovascular or cerebro‐vascular) adj2 insufficien) or (cerebr adj2 deteriorat) or (chronic adj2 (cerebrovascular or cerebro‐vascular)) or (creutzfeldt or jcd or cjd) or (lewy adj2 bod) or (pick adj2 disease) or alzheimer* or binswanger* or deliri* or dement* or huntington* or korsako).tw. 41 36 or 37 or 38 or 39 or 40 42 Caregivers/ 43 (caregiver or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kinship or parent* or relatives or spouse).tw. 44 42 or 43 45 audiovisual aid/ 46 book/ 47 consumer health information/ 48 health education/ 49 medical information system/ 50 health literacy/ 51 health promotion/ 52 information dissemination/ 53 publication/ 54 social media/ 55 telephone/ 56 ("Patient information" or "social media" or Audiovisual or Audio‐visual* or Book* or Leaflet* or Lecture* or Manuals).tw. 57 education/ 58 (Education or Train or Training).tw. 59 community care/ 60 home care/ 61 respite care/ 62 self help/ 63 social support/ 64 ((caregiver* or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kin* or parent* or relatives or spouse) adj5 Support).tw. 65 (counsel or respite).tw. 66 45 or 46 or 47 or 48 or 49 or 50 or 51 or 52 or 53 or 54 or 55 or 56 or 57 or 58 or 59 or 60 or 61 or 62 or 63 or 64 or 65 67 randomized controlled trial/ 68 controlled clinical trial/ 69 random$.ti,ab. 70 randomization/ 71 intermethod comparison/ 72 placebo.ti,ab. 73 (compare or compared or comparison).ti. 74 ((evaluated or evaluate or evaluating or assessed or assess) and (compare or compared or comparing or comparison)).ab. 75 (open adj label).ti,ab. 76 ((double or single or doubly or singly) adj (blind or blinded or blindly)).ti,ab. 77 Double‐Blind Method/ 78 parallel group$1.ti,ab. 79 (crossover or cross over).ti,ab. 80 ((assign$ or match or matched or allocation) adj5 (alternate or group$1 or intervention$1 or patient$1 or subject$1 or participant$1)).ti,ab. 81 (assigned or allocated).ti,ab. 82 (controlled adj7 (study or design or trial)).ti,ab. 83 (volunteer or volunteers).ti,ab. 84 trial.ti. 85 67 or 68 or 69 or 70 or 71 or 72 or 73 or 74 or 75 or 76 or 77 or 78 or 79 or 80 or 81 or 82 or 83 or 84 86 41 and 44 and 66 and 85	Dec 2015: 1857 Jul 2016: 379 May 2017: 331 May 2018: 574 May 2019: 465
PSYCINFO 1806‐May week 2 2019 (Ovid SP) [Date of most recent search: 10 April 2020]	1 dement.ti,ab. 2 alzheimer.ti,ab. 3 exp Dementia/ 4 (lewy* adj2 bod).ti,ab. 5 (frontotemporal or FTD or FTLD).ti,ab. 6 2 or 3 or 4 or 5 7 Caregivers/ 8 (caregiver* or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kinship or parent* or relatives or spouse).ti,ab. 9 7 or 8 10 Educational Audiovisual Aids/ 11 book/ 12 exp Health Education/ 13 Health Literacy/ 14 Health Promotion/ 15 Information Dissemination/ 16 exp Social Media/ 17 exp Telephone Systems/ 18 ("Patient information" or "social media" or Audiovisual or Audio‐visual* or Book* or Leaflet* or Lecture* or Manuals).ti,ab. 19 Education/ 20 (Education or Train or Training).ti,ab. 21 Community Mental Health Services/ 22 Community Services/ 23 Home Care/ 24 Respite Care/ 25 Support Groups/ 26 Self Help Techniques/ 27 Social Support/ 28 ((caregiver* or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kin* or parent* or relatives or spouse) adj5 Support).ti,ab. 29 (counsel or respite).ti,ab. 30 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 31 exp Clinical Trials/ 32 randomly.ab. 33 randomi?ed.ti,ab. 34 placebo.ti,ab. 35 groups.ab. 36 "double‐blind".ti,ab. 37 "single‐blind".ti,ab. 38 RCT.ti,ab. 39 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38 40 6 and 9 and 30 and 39	Dec 2015: 835 Jul 2016: 81 May 2017: 71 May 2018: 77 May 2019: 59
CINAHL (EBSCOhost) [Date of most recent search: 10 April 2020]	S1 (MH "Dementia+") S2 (MH "Delirium") or (MH "Delirium, Dementia, Amnestic, Cognitive Disorders") S3 (MH "Wernicke's Encephalopathy") S4 TX dement* S5 TX alzheimer* S6 TX lewy* N2 bod* S7 TX deliri* S8 TX chronic N2 cerebrovascular S9 TX "organic brain disease" or "organic brain syndrome" S10 TX "normal pressure hydrocephalus" and "shunt" S11 TX "benign senescent forgetfulness" S12 TX cerebr N2 deteriorat* S13 TX cerebral* N2 insufficient* S14 TX pick* N2 disease S15 TX creutzfeldt or jcd or cjd S16 TX huntington* S17 TX binswanger* S18 TX korsako* S19 S1 or S2 or S3 or S4 or S5 or S6 or S7 or S8 or S9 or S10 or S11 or S12 or S13 or S14 or S15 or S16 or S17 or S18 S20 (MH "Caregivers") OR (MH "Caregiver Support") S21 TX caregiver* or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kinship or parent* or relatives or spouse* S22 S20 OR S21 S23 (MH "Books") S24 (MH "Consumer Health Information") S25 (MH "Health Education") S26 (MH "Health Information Systems") OR (MH "Home Health Care Information Systems") S27 (MH "Health Promotion") S28 (MH "Pamphlets") S29 (MH "Social Media") S30 (MH "Telephone") S31 TX "Patient information" or "social media" or Audiovisual* or Audio‐visual* or Book* or Leaflet* or Lecture* or Manuals S32 (MH "Education") S33 TX Education or Train or Training S34 (MH "Community Networks") S35 (MH "Homemaker Services") S36 (MH "Respite Care") S37 TX caregiver* or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kin* or parent* or relatives or spouse* S38 TX support S39 S37 AND S38 S40 TX counsel* or respite S41 S23 OR S24 OR S25 OR S26 OR S27 OR S28 OR S29 OR S30 OR S31 OR S32 OR S33 OR S34 OR S35 OR S36 OR S39 OR S40 S42 S19 AND S41 S43 S22 AND S42 S44 (MH "Randomized Controlled Trials") S45 AB randomly S46 AB placebo S47 AB groups S48 AB randomised S49 TI randomised S50 TI randomized S51 AB randomized S52 AB "double‐blind" S53 TI "double‐blind" S54 TI "single‐blind" S55 AB "single‐blind" S56 AB RCT S57 S44 OR S45 OR S46 OR S47 OR S48 OR S49 OR S50 OR S51 OR S52 OR S53 OR S54 OR S55 OR S56 S58 S43 AND S57	Dec 2015: 1364 Jul 2016: 179 May 2017: 129 May 2018: 275 May 2019: 442
Web of Science Core Collection [Date of most recent search: 10 April 2020]	(dement* OR alzheimer* OR "lew* bod" OR frontotemporal OR FTD OR FTLD OR "severe cognit* impair") AND TOPIC: (cargiver OR care‐giver* OR carer* OR daughter* OR dependents OR families* OR family* OR folk* OR kinship OR parent* OR relatives OR spouse) AND TOPIC: ("Patient information" OR "social media" OR Audiovisual OR Audio‐visual* OR Book* OR Leaflet* OR Lecture* OR Manuals OR Education OR Train OR Training OR counsel* OR respite) AND TOPIC: (random* OR trial OR placebo OR "double‐blind" OR "single‐blind" OR RCT OR "control group*") Timespan: All years. Search language=Auto	Dec 2015: 1171 Jul 2016: 207 May 2017: 267 May 2018: 220 May 2019: 160
LILACS (BIREME) [Date of most recent search: 10 April 2020]	Information OR informações or INFORMAÇÃO or educación OR educação OR education OR manual OR Capacitación OR training [Words] and "cuidador familiar" OR caregiver OR cônjuge OR filha OR hija OR daughter OR family OR familiar [Words] and dementia OR Demencia OR demência OR alzheimers OR Alzheimer [Words]	Dec 2015: 131 Jul 2016: 10 May 2017: 6 May 2018: 6 May 2019: 5
CENTRAL (The Cochrane Library, issue 5 of 12, 2019) [Date of most recent search: 10 April 2020]	#1 MeSH descriptor: [Dementia] explode all trees #2 MeSH descriptor: [Delirium, Dementia, Amnestic, Cognitive Disorders] explode all trees #3 alzheimer* or binswanger* or deliri* or dement* or huntington* or korsako* #4 #1 or #2 or #3 #5 MeSH descriptor: [Caregivers] explode all trees #6 caregiver* or care‐giver* or carer* or daughter* or dependents or families* or family* or folk* or kinship or parent* or relatives or spouse* #7 #5 or #6 #8 MeSH descriptor: [Audiovisual Aids] explode all trees #9 MeSH descriptor: [Books] explode all trees #10 MeSH descriptor: [Consumer Health Information] explode all trees #11 MeSH descriptor: [Information Dissemination] explode all trees #12 MeSH descriptor: [Health Promotion] explode all trees #13 MeSH descriptor: [Health Literacy] explode all trees #14 MeSH descriptor: [Health Information Systems] explode all trees #15 MeSH descriptor: [Pamphlets] explode all trees #16 MeSH descriptor: [Social Media] explode all trees #17 MeSH descriptor: [Telephone] explode all trees #18 "Patient information" or "social media" or Audiovisual* or Audio‐visual* or Book* or Leaflet* or Lecture* or Manuals #19 MeSH descriptor: [Education] explode all trees #20 MeSH descriptor: [Training Support] explode all trees #21 Education or Train or Training #22 MeSH descriptor: [Community Networks] explode all trees #23 MeSH descriptor: [Homemaker Services] explode all trees #24 MeSH descriptor: [Respite Care] explode all trees #25 MeSH descriptor: [Self‐Help Groups] explode all trees #26 MeSH descriptor: [Social Support] explode all trees #27 counsel* or respite #28 #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26 or #27 #29 #4 and #7 and #28	Dec 2015: 1220 Jul 2016: 52 May 2017: 108 May 2018: 276 May 2019: 505
Clinicaltrials.gov (www.clinicaltrials.gov) [Date of most recent search: 10 April 2020]	Search terms: dementia AND condition: carer OR caregiver [Interventional studies] All dates, all status	Dec 2015: 113 Jul 2016: 8 May 2017: 58 May 2018: 92 May 2019: 88
ICTRP Search Portal (http://apps.who.int/trialsearch) [includes: Australian New Zealand Clinical Trials Registry; ClinicalTrilas.gov; ISRCTN; Chinese Clinical Trial Registry; Clinical Trials Registry – India; Clinical Research Information Service – Republic of Korea; German Clinical Trials Register; Iranian Registry of Clinical Trials; Japan Primary Registries Network; Pan African Clinical Trial Registry; Sri Lanka Clinical Trials Registry; The Netherlands National Trial Register] [Date of most recent search: 109 Aperil 2020]	(Title: dementia or Alzheimer or alzheimers or lewy) AND (condition: carer or caregiver) All dates, all status	Dec2015: 12 Jul 2016: 11 May 2017: 15 May 2018: 46 May 2019: 38
TOTAL before de‐duplication and first assessment		Dec 2015: 8168 Jul 2016: 1095 May 2017: 1147 May 2018: 1739 May 2019: 2133 TOTAL: 14,282
TOTAL after de‐duplication		Dec 2015: 7211 Jul 2016: 827 May 2017: 908 May 2018: 1321 May 2019: 1558 TOTAL: 11,825
TOTAL after first assessment by CDCIG information specialist		Dec 2015: 1028 Jul 2016: 183 May 2017: 125 May 2018: 252 May 2019: 422 TOTAL: 2,010

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Caregiver burden	9	597	Std. Mean Difference (IV, Random, 95% CI)	‐0.06 [‐0.35, 0.23]
1.1.1 Support/information plus support	3	156	Std. Mean Difference (IV, Random, 95% CI)	0.12 [‐0.43, 0.66]
1.1.2 Training/information plus training	3	109	Std. Mean Difference (IV, Random, 95% CI)	‐0.14 [‐0.78, 0.50]
1.1.3 Training and support	3	332	Std. Mean Difference (IV, Random, 95% CI)	‐0.17 [‐0.70, 0.36]
1.2 Caregiver mood	8	638	Std. Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.22, 0.12]
1.2.1 Support/information plus support	4	283	Std. Mean Difference (IV, Random, 95% CI)	‐0.06 [‐0.38, 0.25]
1.2.2 Training/information plus training	1	23	Std. Mean Difference (IV, Random, 95% CI)	0.02 [‐0.80, 0.84]
1.2.3 Training and support	3	332	Std. Mean Difference (IV, Random, 95% CI)	‐0.06 [‐0.32, 0.19]
1.3 Caregiver HRQoL	2	311	Std. Mean Difference (IV, Random, 95% CI)	0.10 [‐0.13, 0.32]
1.3.1 Training/information plus training	1	61	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.62, 0.38]
1.3.2 Training and support	1	250	Std. Mean Difference (IV, Random, 95% CI)	0.15 [‐0.10, 0.40]
1.4 Dropouts for any reason	8	661	Risk Ratio (M‐H, Random, 95% CI)	1.15 [0.87, 1.53]
1.4.1 Support/information plus support	3	232	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.59, 1.73]
1.4.2 Training/information plus training	2	70	Risk Ratio (M‐H, Random, 95% CI)	1.42 [0.50, 4.04]
1.4.3 Training and support	3	359	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.75, 1.63]
1.5 Caregiver knowledge and skills	4	223	Std. Mean Difference (IV, Random, 95% CI)	0.20 [‐0.10, 0.50]
1.5.1 Support/information plus support	2	120	Std. Mean Difference (IV, Random, 95% CI)	0.18 [‐0.18, 0.54]
1.5.2 Training/information plus training	1	54	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.65, 0.42]
1.5.3 Training and support	1	49	Std. Mean Difference (IV, Random, 95% CI)	0.61 [0.04, 1.18]
1.6 Use of health and social resources	1		Rate Ratio (IV, Random, 95% CI)	1.05 [0.93, 1.19]
1.7 Institutional care ‐ nursing home placement	1	34	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.11, 3.11]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Caregiver burden	9	650	Std. Mean Difference (IV, Random, 95% CI)	‐0.24 [‐0.51, 0.04]
2.1.1 Support/information plus support	2	119	Std. Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.39, 0.33]
2.1.2 Training/information plus training	6	506	Std. Mean Difference (IV, Random, 95% CI)	‐0.31 [‐0.69, 0.07]
2.1.3 Training and support	1	25	Std. Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.90, 0.68]
2.2 Caregiver mood	11	1100	Std. Mean Difference (IV, Random, 95% CI)	‐0.25 [‐0.43, ‐0.06]
2.2.1 Support/information plus support	1	94	Std. Mean Difference (IV, Random, 95% CI)	‐0.28 [‐0.69, 0.13]
2.2.2 Training/information plus training	8	816	Std. Mean Difference (IV, Random, 95% CI)	‐0.31 [‐0.54, ‐0.08]
2.2.3 Training and support	2	190	Std. Mean Difference (IV, Random, 95% CI)	0.04 [‐0.24, 0.33]
2.3 Caregiver HRQoL	2	257	Std. Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.28, 0.21]
2.4 Dropouts for any reason	12	1266	Risk Ratio (M‐H, Random, 95% CI)	1.51 [1.04, 2.20]
2.4.1 Support/information plus support	1	42	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.17, 7.09]
2.4.2 Training/information plus training	9	994	Risk Ratio (M‐H, Random, 95% CI)	1.51 [0.97, 2.33]
2.4.3 Training and support	2	230	Risk Ratio (M‐H, Random, 95% CI)	1.25 [0.25, 6.22]
2.5 Caregiver knowledge and skills	2	70	Std. Mean Difference (IV, Random, 95% CI)	0.18 [‐0.29, 0.65]
2.5.1 Support/information plus support	1	38	Std. Mean Difference (IV, Random, 95% CI)	0.17 [‐0.47, 0.81]
2.5.2 Training/information plus raining	1	32	Std. Mean Difference (IV, Random, 95% CI)	0.19 [‐0.51, 0.88]
2.6 Institutional care ‐ nursing home placement	1	32	Risk Ratio (M‐H, Random, 95% CI)	2.67 [0.12, 60.93]

*Study characteristics*
Methods	Design: Parallel randomised controlled trial. No. of participating centres: Two: United Christian Hospital and Prince of Wales Hospital, Hong Kong, China. Study dates: January 2015 to June 2016.
Participants	Inclusion criteria: Primary caregivers (spouse, kin, or sibling) aged 25 or above caring for a care recipient diagnosed with mild to moderate Alzheimer's disease. Providing at least 14 hours of care per week for at least 3 months. Exclusion criteria: Presence of signs of the following conditions: severe intellectual deficits, suicidal ideation, psychotic disorders, or lack of the ability to read Chinese and speak Cantonese. No. of participants randomised to intervention: ‐ TBA (n=56). ‐ TGM (n=55). Baseline characteristics: ‐ Caregivers: Mean age was 57.1 years (SD=10.2); 90 females and 21 males. The average years of caregiving were 4 (1.8) with an average of 10.9 (7.6) hours/day spent in caregiving. Mean score of burden (22‐item ZBI) at baseline 30.9 (SD=17.2). ‐ Care recipients: 69 participants (62%) presented moderate dementia, 42 participants (38%) presented severe dementia.
Interventions	Experimental: Telephone‐administered psycho‐education with behavioral activation intervention (TBA). Control: Telephone general monitoring. Length of intervention: Four‐month.
Outcomes	Primary outcomes: ‐ Depressive symptoms (CES‐D). Secondary outcomes: ‐ Caregiver burden (Zarit Burden Scale). Outcomes assessment: An average of about 5 months since baseline.
Notes	Clinical trial registration code: NCT03552159. Funding: Research Council of the Food and Health Bureau of the Government of the Hong Kong Special Administrative Region (Health Care Promotion Fund 0310015). Conflicts of interest: None declared. Fidelity / adherence: Authors report that 60% of participants fully covered the program and 40% adequately covered the program.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Allocation sequence was obtained by random number generation by a staff who was not involved in enrolling/assigning participants... block randomization was used to achieve balance between the numbers of participants in both arms".
Allocation concealment (selection bias)	Low risk	Quote: "The allocation was concealed in sequentially numbered sealed envelopes".
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "... both assessors and participants were blinded to intervention condition".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Assessments were carried out by research assistants who were blind to the group allocation of participants". Comment: Intervention components and procedures were comparable.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: The study presents reasons for losses to follow‐up without relevant differences between arms, also ITT analysis was done.
Selective reporting (reporting bias)	Low risk	Comment: Study registration available (NCT03552159), all prespecified results are reported.
Other bias	Low risk	Comment: No other source of bias detected.

Study	Gustafson 2019
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	D‐CHESS (Dementia–Comprehensive Health Enhancement Support System).	Caregiving booklet.
WHY	D‐CHESS was designed to help with motivation, decision making, stress reduction, and access to services by allowing caregivers to obtain information and support without concern for location, distance, time, confidentiality, or education.	No described.
WHAT materials	Website. Participants were also offered the use of three commercially available sensors: a Bluetooth tracker, a GPS location tracker, and a motion sensor. The Bluetooth tracker would help locate lost items such as keys; the GPS location tracker could be carried by a patient, allowing the caregiver to monitor the patient’s location; and the motion sensor could be used to alert a caregiver if the patient entered specific areas of the home that could be hazardous.	No applicable.
PROCEDURES	This system offered detailed information about dementia, personal accounts of how other caregivers coped, descriptions and locations of services that caregivers may need, and links to vetted online resources. Users could anonymously pose questions to experts, receive suggestions of resources for help, communicate with other caregivers through facilitated discussion groups, and use decision aids to work through key issues. In addition, D‐CHESS services offer other elements proven effective in caregiver programs, such as assertive out‐reach, action planning, and peer and family support, as well as quality informational resources such as expert advice and vetted articles and websites.	No described.
WHO provided	Whole intervention was over the Internet.	No described.
HOW delivered	Online.	Booklet.
WHERE occurred	At home.
WHEN and HOW MUCH	The intervention group received access to the D‐CHESS website for 6 months.	No applicable.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	D‐CHESS automatically collected use data, including: number of participants logging on, number of page views, specific services used, discussion group posts, data input to decision aids, and private messages sent to the Alzheimer’s disease information specialist at the Wisconsin Alzheimer’s Disease Research Center.	No applicable.
HOW WELL actual	Overall, participants continued to access D‐CHESS throughout the study, with 100%, 50%, 71%, 71%, 57%, and 64% logging on during months 1 through 6, respectively.	No applicable.

Study	Hattink 2015
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	STAR E‐Learning (European Skills Training and Reskilling).	Waiting list.
WHY	The STAR training portal was designed to provide dementia care training both for informal and formal caregivers. It is designed as a multilingual e‐learning tool from experts on education, technology, and dementia care.	Participants in the control group were informed they could follow the e‐learning course after post‐test measurements were performed within the experimental intervention.
WHAT materials	The course content was developed from 3 perspectives: · Medical model of dementia: information on types of dementia, symptoms and diagnostics · Functional consequences in daily life and how to compensate for disabilities · Dealing with the psychosocial consequences for the person with dementia and his family	No applicable.
PROCEDURES	The STAR training portal offers the following functionality: · 8 modules on different topics in dementia care (2 at basic level, 6 at intermediate to advanced level): what is dementia; living with dementia; getting a diagnosis; practical difficulties in daily life; emotional impact of dementia; support strategies; positive and empathic communication; looking after yourself · Learning Path Advisor to assess baseline knowledge and confidence, to suggest the point to start the course · Facebook and LinkedIn communities to promote peer support and provide opportunities to contact dementia care professionals The modules consist of text, videos, interactive exercises, knowledge tests, and also include references to other websites, literature, and videos.	No applicable..
WHO provided	Whole intervention was over the Internet.	No applicable.
HOW delivered	Online.	No applicable.
WHERE occurred	At home.
WHEN and HOW MUCH	The intervention group received access to the STAR website for 4 months.	No applicable.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs. Caregivers can follow their own learning path.
MODIFICATIONS	None described.
HOW WELL planned	Pilot study to assess STAR’s usefulness, user friendliness, and impact on knowledge.	No applicable.
HOW WELL actual	As planned.	No applicable.

Study	Hayden 2012
TIDieR item	Experimental intervention		Control intervention
BRIEF NAME	The use of Internet technology for psychoeducation and support with dementia caregivers.		Customary care plus monthly brief telephone calls.
WHY	Data suggest that providing education, social support, and ongoing professional consultation to families involved in the care of a relative with Alzheimer’s disease results in improvement in caregiver psychological status, and sometimes even slows the functional decline of the patient.		No applicable.
WHAT materials	Customary care and access to an intensive, interactive online education and support website.		Customary care and telephone calls.
PROCEDURES	· Online education and support, provided by nine brief educational streaming videos, with brief written brochures, plus non‐compulsory weekly 1‐hour professionally hosted synchronous online chats to review the educational material and problem‐solving care issues, using the rest of the group as sources of feedback. Participants received weekly telephone and email reminders about the chat sessions. · Additional focus cantered on self‐care promotion via behavioural interventions and goal attainment scaling.	Active control condition involving supportive phone calls.
WHO provided	Geriatricians, a geriatric psychiatrist, clinical psychologists, a research sociologist, and master’s and bachelor’s level support staff. Both interventions were provided by the same team.
HOW delivered	Internet.		Telephone.
WHERE occurred	At home.
WHEN and HOW MUCH	6‐month interventions.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	Reports of technological challenges encountered by many of the participants as well as constraints due to VA resources and information security policies.

Study	Huis in het Veld 2020
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Major Self‐Management Support Intervention.	· Medium Self‐Management Support Intervention · Minor Self‐Management Support Intervention
WHY	The intervention is based on the 5 steps of the “5A model” of self‐management support and the person‐centered care theory of Kitwood. · assessing the state of behavior, beliefs, and motivation · advising based upon personal health risks · agreeing on a realistic set of goals · assisting in anticipating barriers and developing a specific action plan · arranging follow‐up.	Not described.
WHAT materials	Emails, online videos, e‐bulletins.	Online videos and e‐bulletins.
PROCEDURES	The major intervention arm consists of the following elements: · 3 personal email contacts with a nurse specialized in dementia care · provision of 6 online videos about how to manage behavior changes in a relative with dementia and to improve self‐efficacy in managing with this behavior · provision of e‐bulletins with practical information about different types of behavior changes and how to manage them The nurse gave feedback on assignments and gave feedback on the plan that the family caregiver came up with in the assignments.There were 6 videos about different types of behavior changes that occur frequently (dependent behavior, aggressive behavior, suspicious behavior, apathy or indifference, nighttime restlessness, and masking behavior). Family caregivers chosen the number of videos they watch and the accompanying assignments that they do themselves, depending on their own needs and the behavior changes that occur in their relative with dementia. The behavior changes covered in the bulletins were the same as in the videos. The e‐bulletins involve assignments to help caregivers translate the generic information to their own situation and to reflect on possible causes of the behavior changes, how they want to influence the behavior, and how they want to cope with it.	· The medium self‐management support intervention consists only of the online videos and e‐bulletins · The minor self‐management support intervention consists only of the e‐bulletins, the same as those in the major and medium support interventions
WHO provided	The personal email contacts were handled by a nurse with a Bachelor’s or Master’s qualification in nursing and with follow‐up training in dementia care.
HOW delivered	Email plus online videos plus e‐bulletins.	Online videos plus e‐bulletins.
WHERE occurred	At home.
WHEN and HOW MUCH	6 weeks.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	No described.

Study	Kajiyama 2013
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	iCare Stress Management e‐Training Program (ICC).	Education/Information‐Only Condition (EOC).
WHY	The iCare program is an adaptation of the psycho‐ educational program ‘Coping with Caregiving’ (CwC) developed by Gallagher‐Thompson and colleagues that aims to teach a set of core coping skills to caregivers for stress management. These include: relaxation training; learning to increase everyday pleasant activities (including if possible some pleasant activities with the person with dementia); cognitive restructuring (of unduly negative appraisals regarding caregiving and themselves); and improved communication skills on how to ask for help effectively from family members and relevant community and medical institutions.	The EOC served as a control for the purpose of obtaining new information about dementia and what to expect in caring for dementia patients. It also controlled for the involvement with relevant information on the Internet and for the general cognitive and experiential capacity required to ‘navigate’ in complex Internet materials.
WHAT materials	Website and video‐recordings.
PROCEDURES	Educational modules had a hierarchical structure. Participants were encouraged to practice specific assignments in each module over a 7‐to‐10‐day interval before moving to the next one. The iCare program consists of the following modules: · information segment about what ‘dementia’ means and what are common problems associated with it · components on dealing with stress including techniques for relaxation, stress management, and challenging unduly negative thoughts about caregiving · behavioral activation (increasing everyday positive activities for oneself and the patient with dementia) · communication skills to improve help‐seeking with family and community institutions as well as improving ability to relate to the patient with dementia · managing difficult behaviours of the patient with dementia · review of ‘healthy habits’ (nutrition and exercise) for the caregiver along with information on national resources they can consult for further on‐going assistance At the end of each module, CGs were asked to create their own individual ‘action plans’ in the workbook requiring them to describe what they had learned by completing the module and relevant assignments and how they planned to use the information from that specific module in the future in their daily lives.	Caregivers assigned to the EOC were exposed to a website containing similar navigational features, but with content focused on information about dementia, obtained from reputable national sources. In addition, links to certain video‐taped information were provided.
WHO provided	Online.
HOW delivered	Online.
WHERE occurred	At home.
WHEN and HOW MUCH	During 3 months.	No applicable.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	No described.

Study	Kwok 2013
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Psychoeducational intervention.	DVD information.
WHY	The intervention is based on theories of psychosocial transition and stress coping, under the framework of cognitive behavioral therapy, and focuses on: · providing emotional support · directing caregivers to appropriate resources · encouraging caregivers to attend to their own physical, emotional, and social needs · educating caregivers on strategies to cope with ongoing problems	No described.
WHAT materials	Manualized psychoeducational intervention.	DVD with educational information about dementia caregiving.
PROCEDURES	The participants in the intervention group were educated and given advice on topics related to dementia caregiving: · knowledge of dementia · skills of communicating with the patient · management of behavioral and psychological symptoms of dementia · caregivers’ own emotional issues · resources available in the community · long‐term care plan The topics covered and the schedule of presentation were similar to typical psychoeducation interventions held “on site” at community centres.	No applicable.
WHO provided	A registered social worker.	No applicable.
HOW delivered	By telephone.	DVD.
WHERE occurred	At home.
WHEN and HOW MUCH	12 sessions (approximately 30 minutes per session, one session per week).	No applicable.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	No described.

Study	Mahoney 2003
TIDieR item	Experimental intervention		Control intervention
BRIEF NAME	TLC System.		Control.
WHY	The theoretical model asserts that the background and context of stress (caregiving relationship), plus the stressor (care recipient’s behaviours), as mediated by caregiver mastery, resulted in manifestations of caregiver stress.		No described.
WHAT materials	The technology consisted of an integrated telephone network system and an IVR computer network system.		No applicable.
PROCEDURES	Caregivers dialled in from any standard touch‐tone telephone and heard the narrator greet them by name, review the menu of four module options, and provide the service they requested. The included modules were: · Weekly caregiver’s conversation: monitored the caregiver’s stress levels and provided information on how to manage the care recipient’s behavioural problems. · Personal mailbox: allowed caregivers to send and receive communications through voice mail among themselves or to communicate with a clinical nurse specialist who directly answered or triaged questions to a multidisciplinary professional panel of Alzheimer’s disease experts. · Bulletin board: in‐home telephone support group that provided personal and caregiver group voice mail, similar to a computer chat group. · Activity‐respite conversation: care recipient distraction module designed to reduce disruptive behaviours and to provide caregivers with respite time.		No applicable.
WHO provided	Internet intervention.		No applicable.
HOW delivered	Telephone‐delivered.		No applicable.
WHERE occurred	At home.
WHEN and HOW MUCH	The intervention group had access to the system for a 12‐month period, after which their passwords were disabled.		No applicable.
TAILORING	Intervention was comprehensively designed and not tailored to cover individual or unmeet needs. However, because caregivers have diverse needs and preferences, the intervention offered multiple components with flexibility to effectively appeal to a variety of users. Participants chose the type of component, frequency, duration, and timing of the usage.	No applicable.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	No described.

Study	Martindale‐Adams 2013
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Telephone support (CONNECT).	Printed materials.
WHY	Content and structure of the intervention were based on the 6‐month REACH II intervention of 12 individual in‐home and telephone sessions and five telephone support group sessions.	No described.
WHAT materials	Session materials consisted of a Caregiver Notebook and commercially available pamphlets. The Notebook comprised 29 behaviour – management chapters of five to eight pages each (i.e., bathing, repeated questions), and 17 caregiver stress/coping chapters (i.e., assertiveness, communication, grief) based on research and practice, written in large print and at a fifth‐grade reading level.	Control caregivers received pamphlets on dementia and safety as well as telephone numbers for local resources.
PROCEDURES	Like REACH, the multi‐component intervention targeted caregiving risks, including risks associated with emotional and physical well‐being, safety, burden, social support, and patient behaviour management. The first six sessions covered all Caregiver Notebook chapters that were standardized to include the following topics: · introduction · basic information about dementia and financial and legal issues · safety · caregiver health and well‐being · communication · problem solving The sessions were semi‐structured telephone calls with education, skills‐building, and support. Each session began with a relaxation exercise, caregiver updates, review of strategies tried from the preceding session’s topic, and the group leader’s presentation on a behaviour management or stress and coping topic.The rest of the session included discussion and practice by the entire group on the session’s topic, selection of individual strategies to try, selection of the next session’s topic, and closure, including another signal breath relaxation exercise.	Control caregivers received pamphlets on dementia and safety as well as telephone numbers for local resources.
WHO provided	Trained professionals.
HOW delivered	Telephone.	Printed materials.
WHERE occurred	At home.
WHEN and HOW MUCH	Groups met 14 times over 1 year. The support groups met bi‐weekly for 2 months and monthly thereafter for 1 year, for a total of 14 hour‐long sessions.	No described.
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	Of the 77 intervention caregivers, 47 (61%) had at least 75% of the 14 sessions and 59 (76.6%) completed at least half. Six caregivers (7.8%) had fewer than three sessions.	No applicable.

Study	Metcalfe 2019
TIDieR item	Experimental intervention		Control intervention
BRIEF NAME	RHAPSODY.		Wait‐list.
WHY	The intervention adopts a multiple‐component model of dementia carer support inspired by the REACH II Study adapted to the care of people with young onset dementia.		No applicable.
WHAT materials	Online device		No applicable.
PROCEDURES	The programme features seven modules: · What is young onset dementia? · Medical perspective on young onset dementia · Frequent problems and solutions · Dealing with challenging behaviours · Family issues · How to get help · Looking after yourself		No applicable.
WHO provided	Internet intervention.		No applicable.
HOW delivered	Online.		No applicable.
WHERE occurred	At home.
WHEN and HOW MUCH	6 weeks.		No applicable.
TAILORING	Intervention was comprehensively designed, not tailored to cover individual or unmeet needs.	No applicable.
MODIFICATIONS	None described.		No applicable.
HOW WELL planned	No described.
HOW WELL actual	No described.

Study	NCT00056316
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Behavioural intervention.	Basic education.
WHY	No described.
WHAT materials	Video, workbook and telephone calls.	37‐page Basic Care Guide and telephone calls.
PROCEDURES	Multicomponent behavioral intervention using 10‐session video series, workbook, and weekly telephone coaching sessions.	Participants receive 37‐page Basic Care Guide and bi‐weekly telephone calls by a trained staff member.
WHO provided	Trained staff member.
HOW delivered	Video plus telephone.	Booklet.
WHERE occurred	No described.
WHEN and HOW MUCH	No described.
TAILORING	No described.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	No described.

PERMALINK

Remotely delivered information, training and support for informal caregivers of people with dementia

Eduardo González-Fraile

Javier Ballesteros

José-Ramón Rueda

Borja Santos-Zorrozúa

Ivan Solà

Jenny McCleery

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Background

Description of the condition

Description of the intervention

Information

Training

Support

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Primary outcomes

Secondary outcomes

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

Measures of treatment effect

Unit of analysis issues

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

'Summary of findings' tables

Results

Description of studies

Results of the search

1.

Included studies

Setting and participants

Interventions

1. TIDieR ‐ Au 2015.

2. TIDier ‐ Au 2019.

3. TIDieR ‐ Blom 2015.

4. TIDieR ‐ Brennan 1995.

5. TIDieR ‐ Cristancho‐Lacroix 2015.

6. TIDieR ‐ Czaja 2013.

7. TIDieR ‐ Davis 2994.

8. TIDieR ‐ Dowling 2014.

9. TIDieR ‐ Duggleby 2018.

10. TIDieR ‐ Gant 2007.

11. TIDieR ‐ Gustafson 2019.

12. TIDieR ‐ Hattink 2015.

13. TIDieR ‐ Hayden 2012.

14. TIDieR ‐ Huis in het Veld 2020.

15. TIDieR ‐ Kajiyama 2013.

16. TIDieR ‐ Kwok 2013.

17. TIDieR ‐ Mahoney 2003.

18. TIDieR ‐ Martindale‐Adams 2013.

19. TIDieR ‐ Metcalfe 2019.

20. TIDieR ‐ NCT00056316.

21. TIDieR ‐ NCT03417219.

22. TIDieR ‐ Nunez‐Naveira 2016.

Study	NCT03417219
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Education and Skill Building Rehabilitation‐mobile (ESBR‐m).	Usual care plus supplemental educational materials.
WHY	No described.
WHAT materials	Internet contents.	Educational materials.
PROCEDURES	Participants randomised to the ESBR‐m group will participate in four, 90‐minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.	Participants randomised to the usual care group will receive supplemental educational materials.
WHO provided	No described.
HOW delivered	Internet.	Booklets.
WHERE occurred	At home.
WHEN and HOW MUCH	Four, 90‐minute group sessions.	No applicable.
TAILORING	No described.
MODIFICATIONS	None described.
HOW WELL planned	No described.
HOW WELL actual	No described.

Study	Nunez‐Naveira 2016
TIDieR item	Experimental intervention		Control intervention
BRIEF NAME	UnderstAID.		Participants in the control group did not use the application and maintained their usual lifestyle.
WHY	No described.		No applicable.
WHAT materials	Smartphone, PC or Tablet.		No applicable.
PROCEDURES	The understAID consists on a Learning section with a database of contents organized in 5 modules with information about 15 different topics. The topics cover information about the care of a person with dementia and caring for oneself as a caregiver, and consist of text, videos, and images and they also include references to other websites. The modules and topics included in understAID are: · Module 1, Cognitive Declines (Topics: Attention, Memory, and Orientation) · Module 2, Daily Tasks (Topics: Bathing, Incontinence, Massage and Touch, and Physical Exercises) · Module 3, Behavioural Changes (Topics: Anxiety and Agitated Behaviour, Depressive Mood, Manic Symptoms, and Emotional Control and Recognition) · Module 4, Social Activities (Communication and Apathy and Loss of Motivation) · Module 5, You as a Caregiver (Topics: Coping with Own Stress and Motivation). Additionally, it has a Social Network section where the caregivers can interact with other participants and exchange information and opinions. This section was moderated by the researchers of the study.		No applicable.
WHO provided	Internet intervention.		No applicable.
HOW delivered	Online.		No applicable.
WHERE occurred	At home.
WHEN and HOW MUCH	Three months.		No applicable.
TAILORING	Intervention was comprehensively designed, not tailored to cover individual or unmeet needs. However, understAID also included the option of filling in an interactive customisation questionnaire with questions about the level of dementia of the person cared by the informal caregiver and about the preferences, energy, and time availability for learning of the caregiver. By answering these questions at the entry of the application, the information level showed to the informal caregivers is personalized and adjusted to their personal situation.	No applicable.
MODIFICATIONS	None described.		No applicable.
HOW WELL planned	No described.		No applicable.
HOW WELL actual	No described.		No applicable.

Study	Torkamani 2014
TIDieR item	Experimental intervention		Control intervention
BRIEF NAME	ALADDIN.		The participants in the control group were only assessed at the study three time points, without any further contact or intervention.
WHY	No described.		No applicable.
WHAT materials	Internet contents.		No applicable.
PROCEDURES	ALADDIN is a computerized platform designed to offer avenues of support and information to the carer. It also manages and communicates information related to the patient with dementia and their carers from their home to the clinicians, facilitating distant monitoring. ALADDIN has four key features: · ‘ALADDIN TV’ provides information and educational material about dementia, as well as musical entertainment and relaxation and exercise techniques · The ‘SOCIAL NETWORKING’ feature provides a forum for carers using ALADDIN to communicate with each other · ‘MY TASKS’ is the distant monitoring feature of ALADDIN, where carers complete questionnaires about their own and their relatives’ health. Their responses can subsequently generate clinical alerts based on set parameters, comparing new responses to previous data, resulting in the immediate detection of change by the clinicians monitoring the system · The ‘CONTACT US’ feature allows the carer to alert the clinical site and/or generate a request for contact		No applicable.
WHO provided	Internet intervention.		No applicable.
HOW delivered	Online.		No applicable.
WHERE occurred	At home.
WHEN and HOW MUCH	The project ran for 6 months.
TAILORING	Intervention was comprehensively designed, not tailored to cover individual or unmeet needs. However, being the primary users of ALADDIN, the caregivers chose the schedule of their tasks.	No applicable.
MODIFICATIONS	None described.		No applicable.
HOW WELL planned	The system was monitored twice daily by the clinical teams.		No applicable.
HOW WELL actual	No described.		No applicable.

Study	Tremont 2008
TIDieR item	Experimental intervention		Control intervention
BRIEF NAME	Family Intervention: Telephone Tracking – Dementia (FITT‐D).		Standard care.
WHY	The intervention is delivered entirely over the telephone. Theoretical underpinnings of the intervention are based on psychosocial transition, transactional stress and coping, and a systems view of family functioning.		No applicable.
WHAT materials	Treatment manual and interventions guide. Telephone.		No applicable
PROCEDURES	Telephone calls included an initial call (orientation and psychoeducation), weekly calls for six weeks, 12 additional contacts every two weeks, and four monthly termination calls. Initial contacts lasted approximately 60 minutes, and follow‐up contacts lasted about 15–30 minutes. The calls focused on providing emotional support, directing caregivers to appropriate resources, encouraging caregivers to attend to their own physical, emotional and social needs, and teaching caregivers strategies to cope with ongoing problems. The intervention did not provide case management, serve as a question‐and‐answer hotline, or provide psychotherapy over the telephone. The FITT method consists of two stages: · The initial stage, Orientation and Psychoeducation, involved providing caregivers with a rationale for the FITT, an introduction to educational and resource materials, a description of what would happen during future phone contacts and an assessment of key areas thought to be instrumental in addressing caregiver burden and mental health (i.e., caregivers’ health, functioning, mood, thinking and family life). The psychoeducation component of this initial stage involved reviewing information about dementia and common psychological, emotional, psychosocial and medical effects of caregiving · The second stage, Follow‐up, involved weekly and bi‐weekly contacts in which new problems were identified, positive and negative changes in caregivers or care recipients were discussed, and psychoeducational information was reviewed and applied for particular situations. The final four follow‐up calls (monthly) addressed issues of termination by allowing caregivers to anticipate FITT contacts coming to an end and to foster reliance on the support network established during the intervention.		No applicable.
WHO provided	Two master’s level therapists who were trained in the FITT‐D procedure delivered the intervention. Doctoral‐level staff supervised therapists weekly to ensure adherence to the protocol and minimize drift.		No applicable.
HOW delivered	Telephone.		No applicable.
WHERE occurred	At home.
WHEN and HOW MUCH	23 telephone contacts over 12 months. Initial contacts lasted approximately 60 minutes, and follow‐up contacts lasted about 15–30 minutes. The intervention involved approximately 12 hours of contact between the therapist and caregiver.		No applicable.
TAILORING	Intervention was comprehensively designed, not tailored to cover individual or unmeet needs.	No applicable.
MODIFICATIONS	None described.		No applicable.
HOW WELL planned	Sessions were audio‐ taped, and two raters reviewed 30 randomly selected telephone contacts and independently completed adherence and competence scales.		No applicable.
HOW WELL actual	No described.		No applicable.

Study	Tremont 2015
TIDieR item	Experimental intervention	Control intervention
BRIEF NAME	Family Intervention: Telephone Tracking‐Caregiver (FITT‐C).	Telephone Support (TS).
WHY	The theoretical framework of FITT‐C is based on psychosocial transition, transactional stress and coping, and a systems view of family functioning. The three underlying theories of FITT‐C are geared toward enhancing coping within the caregiver through active problem solving and facilitating positive changes within the family system.	The control condition was designed to account for nonspecific therapeutic factors, such as interpersonal contact and relationship. The approach was based on a nondirective control condition.
WHAT materials	Telephone.	Telephone.
PROCEDURES	Focused on providing dementia education, emotional support, directing caregivers to appropriate resources, encouraging caregivers to attend to their physical, emotional, and social needs, and teaching caregivers strategies to cope with ongoing problems. The FITT method consisted of an initial orientation and psycho‐ education call that involved providing caregivers with a rationale of FITT, an introduction to the resource materials, a description of future telephone contacts, and education about dementia and effects of caregiving. The remaining contacts identified changes since the last call, assessed key areas for the caregiver (i.e., health, functioning, mood, social support, and family life), and provided interventions and psychoeducation to help caregivers solve problems and use family resources. The focus of the final two calls changed to identifying helpful aspects of contacts and how these functions could be met after termination. After the final call, the therapist prepared a letter briefly highlighting the progress during the intervention and encouraged the caregiver to continue to develop and use adaptive coping strategies.	The primary goal of this condition was to provide nondirective support for caregivers through empathic and reflective listening and open‐ended questioning. The role of the therapist was to provide unconditional positive regard to caregivers and to establish a supportive relationship. Therapists were discouraged from providing directive strategies, such as education, problem‐solving, advice‐giving, or task directives. However, education was not withheld if the caregiver had the wrong information.
WHO provided	Individuals recruited to serve as therapists had experience working with dementia patients and/or care‐ givers or psychotherapy experience working with adults. Therapists were required to be master’s level and received training in dementia and caregiving. FITT‐C therapists received additional training in the intervention method.
HOW delivered	Telephone.
WHERE occurred	At home.
WHEN and HOW MUCH	16 telephone contacts over 6 months. Although initial telephone contacts had standardized durations (approximately 60 minutes), follow‐up contacts varied depending on the severity of caregiver problems (15–30 minutes).
TAILORING	Interventions were comprehensively designed, not tailored to cover individual or unmeet needs.
MODIFICATIONS	None described.
HOW WELL planned	Quality control was implemented by weekly supervision of both the FITT‐C and TS therapists. All telephone contacts were audiotaped, and a subset was reviewed during supervision sessions to ensure adherence and to better guide therapists’ intervention strategies. Any deviations from the treatment protocol were brought to the therapist’s attention for remediation.
HOW WELL actual	The number of missed telephone calls from 16 planned calls was comparable between conditions with an average of 1.81 missed calls for FITT‐C and 1.22 for TS. The average call length was slightly longer for the FITT‐C group (37 minutes) compared with TS (30 minutes).

Study	Winter 2007
TIDieR item	Experimental intervention		Control intervention
BRIEF NAME	Telesupport group treatment.		Control condition.
WHY	No described.		No applicable.
WHAT materials	Conference‐calling technology (Toshiba Digital Business Telephone Model DKT2010‐S System and Centrex teleconference service) to link 5 caregivers per group for an hour weekly.		Nurses and an educational booklet.
PROCEDURES	The primary goal was to enhance caregiver ability to manage daily stressors by providing emotional support and validation. Initially, facilitators focused on developing group cohesion. As groups progress, disclosure of intimate problems and personal conflicts emerge. Caregivers express emotions and share coping strategies including cognitive reframing and practical approaches to organizing care routines. They also assist each other in problem solving and share educational resources. The mutual support and validation provided by group members normalize experiences and provide a supportive social network, core to the service model.		No described.
WHO provided	Telesupport groups were conducted by trained social workers.		No applicable.
HOW delivered	Teleconference Group format.		No applicable.
WHERE occurred	At home.
WHEN and HOW MUCH	26 possible sessions in the 6 months following baseline.		No applicable.
TAILORING	Intervention was comprehensively designed, not tailored to cover individual or unmeet needs.	No applicable.
MODIFICATIONS	None described.		No applicable.
HOW WELL planned	No described.		No applicable.
HOW WELL actual	Telesupport group caregivers participated in an aver‐ age of 14.8 sessions, of a possible 26.		No applicable.

Interventions involving training, support or both (with or without information) compared to usual treatment, waiting list or attention for informal caregivers of people with dementia
Participants or population: Informal caregivers of people with dementia Setting: Community Intervention: Any intervention including information, training or support Comparison: Usual treatment, waiting list or attention control
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Risk with usual treatment, waiting list or attention	Risk with any intervention
Caregiver burden assessed with: self‐reported scales ‐ lower score indicates less burden follow up: median 24 weeks	‐	SMD 0.06 lower (0.35 lower to 0.23 higher)	‐	597 (9 RCTs)	⊕⊕⊕⊝ MODERATE ¹	Any intervention probably does not affect caregiver burden. There are no important differences in effect estimates among type of interventions: SMD 0.12 higher for support or support with information SMD 0.14 lower for training or training with information SMD 0.17 lower for multicomponent interventions involving support and training
Caregiver mood assessed with: self‐reported scales ‐ lower score indicates fewer depressive symptoms follow up: median 24 weeks	‐	SMD 0.05 lower (0.22 lower to 0.12 higher)	‐	638 (8 RCTs)	⊕⊕⊕⊝ MODERATE ¹	Any intervention probably does not affect caregiver mood ‐ depressive symptoms. There are no important differences in effect estimates among type of interventions: SMD 0.06 lower for support or support with information SMD 0.02 higher for training or training with information SMD 0.06 lower for multicomponent interventions involving support and training
Caregiver health‐related quality of life (HRQoL) assessed with: self‐reported scales ‐ higher score indicates better QoL follow up: range 6 weeks to 24 weeks	‐	SMD 0.1 higher (0.13 lower to 0.32 higher)	‐	311 (2 RCTs)	⊕⊕⊕⊝ MODERATE ²	Any intervention probably does not affect caregiver health‐related quality of life. There are no important differences in effect estimates among type of interventions: SMD 0.12 lower for training or training with information SMD 0.15 higher for multicomponent interventions involving support and training
Dropouts for any reason assessed with: number of dropouts for any reason throughout the trial follow up: median 18 weeks	Study population		RR 1.15 (0.87 to 1.53)	661 (8 RCTs)	⊕⊕⊝⊝ LOW ^{3 4}	Any intervention probably results in little or no difference in dropouts for any reason. There are no important differences in effect estimates among type of interventions: RR 1.01 for support or support with information RR 1.42 for training or training with information RR 1.10 for multicomponent interventions involving support and training
	194 per 1000	223 per 1000 (169 to 296)
Use of health and social resources assessed with: Frequency of use throughout the trial follow up: mean 24 weeks	Study population		Rate ratio 1.05 (0.93 to 1.19)	4776 person‐weeks (1 RCT)	⊕⊕⊕⊝ MODERATE ⁵	Any intervention probably results in little to no difference in use of health and social resources.
	204 per 1000	214 per 1000 (190 to 243)
Institutional care ‐ nursing home placement assessed with: Frequency of nursing home placement throughout the trial follow up: median 24 weeks	Study population		RR 0.59 (0.11 to 3.11)	34 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{6 7}	The evidence is very uncertain about the effect of any intervention on institutional care ‐ nursing home placement.
	188 per 1000	111 per 1000 (21 to 583)
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  CI: Confidence interval; HRQoL: Health‐related quality of life; QoL: Quality of life; RCT: Randomised controlled trial; RR: Risk ratio; SMD: Standardised mean difference
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

*Study characteristics*
Methods	Design: Multicentre, parallel randomised study. No. of participating centres: Two centres (United Christian Hospital; Prince of Whales Hospital; Hong Kong, China) Study dates: Not reported.
Participants	Inclusion criteria: Informal caregivers aged 25 or older, caring for a familiar diagnosed of Alzheimer's disease for at least 3 months. Exclusion criteria: Participants who showed signs of severe intellectual deficits, demonstrated suicidal ideation, exhibited evidence of psychotic disorders, or could not read or speak fluent Chinese/Cantonese. No. of participants randomised to interventions: ‐ PsyED with BA (n = 51). ‐ PsyED only (n = 45). Baseline characteristics: ‐ Caregivers: Mean age for participants was 56.2 years (SD = 10.6). Most caregivers were females (76 of 93, 82%), spouses or children of AD patients (85 participants of 93, 91%). The mean time for caring was 10.4 hours/day (SD = 8.9). The mean CES‐D score was 13.5 (SD = 8.0). ‐ Care recipients: Mean age was 80.9 years (SD = 6.6). There were 60 females of 93 (64.5%) and 33 males of 93 (35.5%). Mean MMSE was 15.7 (SD = 5.6).
Interventions	Experimental: Psychoeducation with telephone‐assisted behavioral activation (PsyED‐BA). All participants received a psychoeducation program via telephone for 4 weeks. Then, the experimental group received eight biweekly telephone follow‐up calls of BA practice focused on pleasant event scheduling and improving communications. Control: Psychoeducation only (PsyED). All participants received a psychoeducation program via telephone for 4 weeks. Then, the control group received eight biweekly telephone follow‐up calls of general discussion of psychoeducation and related information. Length of intervention: 4 months.
Outcomes	Primary outcomes: ‐ Center for Epidemiologic Studies‐Depression Scale (CES‐D) (range scores 0 to 30, higher scores denote more depressive symptoms). Secondary outcomes: ‐ None reported Outcomes assessment: At 4 months.
Notes	Clinical trial registration code: Not reported. Funding: Food and Health Bureau of the Hong Kong SAR Government (HKPolyU‐2011‐K‐JB3). Conflicts of interest: None declared.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: Study described as randomised, however the process of randomization is not described.
Allocation concealment (selection bias)	Unclear risk	Comment: There is no information on allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: There is not information on blinding procedures for participants, professionals were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Research staff carrying out the assessments and interventions had no knowledge of the allocation. All assessments at the three time points were carried out by research staff not involved in executing the PsyED program or the subsequent interventions". Comment: Intervention components and procedures were comparable.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Data recorded from 93 caregivers of 96 randomised, and the study provides reasons for discontinuation on treatment by arm.
Selective reporting (reporting bias)	Unclear risk	Comment: There is not clinical trial registration and/or available protocol.
Other bias	High risk	Comment: Break of randomization. Data added to a former pilot study already published.

*Study characteristics*
Methods	Design: Parallel randomised study. No. of participant centres: Dutch Alzheimer’s Society; The Netherlands. Study dates: Between 2010 and 2012.
Participants	Inclusion criteria: Family caregivers of people with dementia with at least some symptoms of depression or anxiety or feelings of burden (CES‐D > 4 or HADS‐A > 3 or a burden score of at least 6 on a scale ranging from 0 to 10). Exclusion criteria: Caregivers with a high level of depression or anxiety (CES‐D > 15 or HADS‐A > 7) or who had suicidal thoughts were first evaluated by an elderly care physician for evaluation and to refer those who were in need of immediate medical treatment. No. of participants randomised to interventions: ‐ Internet course Mastery over Dementia (MoD) (n = 151). ‐ Minimal intervention (digital newsletters, e‐bulletins) (n = 100). Baseline characteristics: ‐ Caregivers: Mean age for participants was 61.2 years (SD = 12.4). Most caregivers were females (170 of 245, 69%), spouses of dementia patients (143 participants of 245, 58%). The mean CES‐D score was 17.4 (SD = 9.4). ‐ Care recipients: Mean age for patients was 75.9 years (SD = 9.4). Most were females (148 of 245, 60%). The mean severity of dementia measured by IQ‐CODE was 58.9 (SD = 5.7).
Interventions	Experimental: Internet course Mastery over Dementia (MoD). The Internet course consists of 8 lessons and a booster session with the guidance of a coach monitoring the progress of participants and evaluating the homework. Control: Digital newsletters (e‐bulletins). Caregivers received a minimal intervention consisting of digital newsletters with practical information on providing care for someone with dementia. The bulletins were sent by email according to a fixed schedule (every 3 weeks) over nearly 6 months. Lenght of intervention: 5 ‐ 6 months.
Outcomes	Primary outcomes: ‐ Depression, assessed by the Center for Epidemiologic Studies Depression Scale (CES‐D), (scores range 0 to 30, higher scores denote more depressive symptoms). Secondary outcomes: ‐ Anxiety, assessed by the 7‐item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS) (scores range 0 to 21, higher scores denote more anxiety symptoms). ‐ Role overload, assessed by the Self‐Perceived Pressure from Informal Care scale (SPPIC), (range score 0 to 9, higher scores denote higher role overload). ‐ Caregiver perceived stress, assessed by the Dutch version of the Revised Memory and Behavioral Problem Checklist (RMBPC), (mean product score ranging from 0 to 16, higher scores represent higher burden). ‐ Sense of competence, assessed by the SSCQ scale (score range 0 to 7, higher scores represent higher sense of competence). ‐ Severity of dementia (IQCODE), (score range 0 to 64, higher scores denote higher severity). Outcomes assessment: At 5 ‐ 6 months.
Notes	Clinical trial registration code: Dutch trial register (NTR2051). Funding: Supported by the Alzheimer’s Society in the Netherlands, the health care provider Geriant and the VU University. Conflicts of interest: None declared.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A researcher not connected to the study used a computerized random‐number generator for block randomization with variable sizes (experimental group=3: comparison group = 2)".
Allocation concealment (selection bias)	Unclear risk	Comment: There is no information on procedures to conceal random allocation.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Participants did not know whether the intervention they received was the experimental or the comparison intervention. The data were all collected via the Internet with no intermediary interviewer."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The data were all collected via the Internet with no intermediary interviewer".
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: There are differential reasons for follow‐up between trial arms; 59 of 151 participants (39.1%) were lost to follow‐up in the intervention group, whereas 11 of 100 participants (11%) were lost to follow‐up in the control intervention.
Selective reporting (reporting bias)	Low risk	Comment: There is a clinical trial registration and a published protocol for the study.
Other bias	Low risk	Comment: None detected.

*Study characteristics*
Methods	Design: Parallel randomised study. No. of participant centres:1 day care centre in Paris, France. Study dates: Between 2011 and 2014.
Participants	Inclusion criteria: French‐speaking caregivers of community‐dwelling persons with Alzheimer’s disease (DSM criteria). Caregivers had to spend at least 4 hours per week with their relative, be aged 18 years or older, scored 12 or more on the Perceived Stress Scale (PSS‐14), and have access to a computer with Internet connection. Exclusion criteria: Professional caregivers. No. of participants randomised to interventions: ‐ Password‐protected website program (Diapason) (n = 25). ‐ Usual care (information) (n = 24). Baseline characteristics: Caregivers: Mean age for participants was 61.6 years (SD = 11.6). Most caregivers were females (32 of 49, 65%), spouses or daughters/sons of AD patients (47 participants of 49, 96%). The mean self‐perceived stress (PSS‐14) was 24.3 (SD = 7.9). Care recipients: The mean time since onset of symptoms was 4.4 years (SD = 3.3). The mean MMSE score was 18.7 (SD = 5.0).
Interventions	Experimental: Usual care plus the Diapason program. Twelve thematic sessions were sequentially and weekly unblocked once the previous one was entirely viewed. Each session included theoretical and practical information, videos of health professionals, and a practice guide for applying the session’s content in real life. Participants could access different website sections (i.e., relaxation training, forum) for as long as they wished at any time. Intervention targeted (1) caregivers’ beliefs about illness and the caregiving role, (2) caregivers’ skills to manage daily life difficulties, and (3) caregivers’ social support and help‐seeking behavior to obtain respite or financial support, and to meet and discuss with peers through a forum. Control: Usual care. Information about the illness during their semiannual follow‐up with their geriatrician. The control group participants were given access to the Diapason program at the end of the study. Lenght of intervention: 3 months.
Outcomes	Primary outcomes: ‐ Perceived stress of caregivers, measured by the item Perceived Stress Scale (PSS‐14), (score range 0 to 56, higher scores indicate higher stress levels). Secondary outcomes: ‐ Self‐efficacy, measured by the Revised Scale for Caregiving Self‐Efficacy (RSCS), (3 self‐efficacy domains with a score range from 0 to 100 each one, higher scores indicate a higher degree of confidence for each situation: obtaining respite, responding to disruptive behaviour, and controlling upsetting thoughts). ‐ Perception and reaction to cognitive or behavioral symptoms, evaluated with the Revised Memory and Behavior Problems Checklist (RMBPC), (score range 0 to 96, higher scores indicate greater perceived burden). ‐ Subjective burden, evaluated with the Zarit Burden Interview (ZBI), (score range 0 to 88, higher scores denote greater burden). ‐ Depressive symptoms, measured with a version of the Beck Depression Inventory (BDI‐II), (range score 0 to 63, higher scores indicate higher levels of depressive symptoms). ‐ Self‐perceived health, measured with the Nottingham Health Profile (NHP), (range score 0 to 100, lower scores indicate less QoL). Outcomes assessment: At 3 months (final assessment), and 6 months (follow‐up assessment).
Notes	Clinical trial registration code: NCT01430286. Funding: French Health Ministry (Projet de Recherche en Qualité Hospitalière 2009‐PREQHOS 2009) and Fondation Méderic Alzheimer project grants 2012‐2014. Conflicts of interest: Some authors and researchers were involved in the development of the Diapason web program. Fidelity / adherence: Authors reported that 71% of participants completed the protocol and validated at least 10 of 12 outline sessions.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Participants were recruited and randomised offline in 2 parallel groups based on a computer‐generated randomization list using blocking and stratification by sex and relationship (spouses vs non‐spouses)".
Allocation concealment (selection bias)	Unclear risk	Comment: There is no information on procedures to conceal random allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Study described as unblinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: Intervention components and procedures were not comparable with participants not blind to intervention and subjective participant‐reported outcomes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: 8 participants of 25 (32%) dropped out from the intervention arm, 7 participants of 24 (29.2%) dropped out from the control arm. Reasons for discontinuation on treatment reported.
Selective reporting (reporting bias)	Low risk	Comment: There is a clinical trial registration (NCT01430286).
Other bias	Low risk	Comment: None detected.