Cristancho‐Lacroix 2015.
Study characteristics | ||
Methods |
Design: Parallel randomised study. No. of participant centres:1 day care centre in Paris, France. Study dates: Between 2011 and 2014. |
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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). |
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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. |
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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). |
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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. |
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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. |