Tremont 2008a.

Methods	A randomised controlled trial (study dates not reported)
Participants	Caregivers of people with dementia recruited from memory disorder clinics, support groups, and newspaper or television advertisements in the Southern New England region of the United States of America. Caregivers were aged 21 years or older; lived with a relative with dementia in the community; and provided a minimum of four hours of supervision or direct care per day for at least six months prior to enrolment. Sixty caregivers were enrolled in the study at baseline, with 32 assigned to the treatment condition and 28 assigned to standard care. By the 12‐month assessment point, 33 caregivers had data for analysis, with 16 caregivers in the FITT‐D group and 17 caregivers in standard care. There were 20 spousal caregivers and 13 adult child caregivers. Caregiver age ranged from 41‐87 years with an overall group mean of 63.30 years (SD 11.836). The majority were female (n = 26) and male (n = 7). Both groups were similar in terms of years of education; mean caregiver years of education in the intervention group was 14.22 (3.41) and in the control group 15.88 (2.14).
Interventions	Intervention: Family Intervention: Telephone Tracking – Dementia (FITT‐D) plus a binder containing local resource information (e.g. list of support groups, adult day care centres) and educational material from the Alzheimer’s Association (n = 32) Aim: To examine the preliminary efficacy of FITT‐D, a multicomponent intervention that is delivered in 23 telephone contacts over 12 months Interventionist(s): Master’s level therapists (counsellors, nurses, social workers – confirmed by author email) Mode of delivery: Telephone Duration: One year (one initial call, then weekly for 6 weeks, 12 additional contacts every 2 weeks and 4 monthly termination calls. Initial contacts lasted 60 minutes, follow‐up contact 15‐30 minutes giving approximately 12 hours of contact between the therapist and caregiver). Content: 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 addressed a broad range of issues and problems related to caregiving. 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 biweekly 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 initial and follow‐up calls were structured around assessment of key areas of functioning in both the caregiver and care‐recipient. Specific interventions were applied at therapists’ discretion, including supportive approaches (i.e. empathy, giving permission, normalising, provision of information, validation, or venting) or more active strategies (i.e. bibliotherapy, interpretation, positive reframing, problem‐solving, reference to resource packet, referral, and setting task directives). 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. Standardisation: The two therapists were trained in the FITT‐D procedure and were required to achieve at least 80% correct on a 50‐item multiple choice test about dementia and the FITT treatment manual prior to initiating treatment. Doctoral staff supervised therapists weekly to ensure adherence to the protocol and minimise drift. Comparison group: No telephone intervention. They received a binder containing local resource information e.g. list of support groups, adult day care centres, and educational material from the Alzheimer’s Association (n = 28).
Outcomes	1. Quality of life: SF‐36 General Health; higher scores indicated better quality of life. 2. Burden: Burden Interview (ZBI). This 22‐item inventory assessed caregivers’ subjective feelings of the impact of caregiving on emotional and physical health functioning, social life, and financial status. Higher scores reflected greater burden. The scale has been shown to have good internal consistency, content validity, and test–retest reliability. Higher scores signified greater burden. Revised Memory and Behavior Problem Checklist (RMBPC). This 24‐item checklist requires caregivers to rate the frequency of problem behaviours and memory difficulties in patients during the previous week and caregiver ratings of their own reaction to each of the behaviour problems. Ratings are made on a five‐point scale for frequency of behaviour problems (0 = never occurs to 4 = occurs daily or more often) and reactions to these problems (0 = not at all bothered/upset to 4 = extremely). Higher scores indicated greater burden. 3. Psychological health (depression) Geriatric Depression Scale (GDS). The GDS is a 30‐item self‐report yes/no measure that is designed specifically for older adults by excluding somatic signs and symptoms of depression. Total scores range from 0 to 30. Higher scores indicated depression. 4. Knowledge and understanding: Alzheimer’s Disease Knowledge Test; higher scores indicated greater knowledge. 5. Health status and well‐being (self‐efficacy): Self‐Efficacy Scale; higher scores indicated greater self‐efficacy. 6. Satisfaction with the intervention: Treatment satisfaction, caregivers in the FITT‐D group completed a 12‐item treatment satisfaction questionnaire. Higher scores indicated greater satisfaction. Date were collected at 12 months (end of intervention) via face‐to‐face assessments with caregivers at their homes.
Notes	For the outcome burden, the results from the Revised Memory and Behavior Problem Checklist (RMBPC) are used in this review. Funding source: Grant from National Institute of Mental Health (MH62561; G.Tremont, PI) (p.516).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Urn randomisation (p.507)
Allocation concealment (selection bias)	Unclear risk	Insufficient information to assess
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Unable to blind due to nature of the intervention
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Research assistants were blinded to group membership (p.507).
Incomplete outcome data (attrition bias) All outcomes	High risk	Intervention group: n = 15 (47%) (n = 11 due to death of care‐recipient); control group: n = 12 (43%) (n = 4 due to death of care‐recipient) (p.511)
Selective reporting (reporting bias)	High risk	Provided results on the main outcomes (burden and depression) and reported on the additional measure to address secondary goal of the intervention but did not report actual statistics for QoL, self‐efficacy, knowledge, and satisfaction with the intervention (p.513).
Other bias	Low risk	No baseline imbalances (Table 1, p.511). Analysis of differences between those who completed and did not complete the 12‐month assessment and whose care‐recipients had died showed that care‐recipient age was the only statistically significant difference between the groups (p.511).