Connell 2009.

Methods	Randomised controlled trial (study dates not reported)
Participants	Caregivers were wives of people with dementia recruited from the Michigan Alzheimer’s Disease Research Center (MADRC) and local chapters of the Alzheimer’s Association (AA) in Michigan and Ohio. The average age of the sample was 66.8 years (SD = 9.4), the majority (65.7%) had at least some education beyond high school and described themselves as white/caucasian (92.7%). About one‐fifth (21.9%) were employed part‐ or full‐time.
Interventions	Intervention: Health First (n = 74) Aim: To assess whether compared with baseline, participants in the Health First showed greater improvements in selected outcomes than the control group Interventionist(s): Trained behaviour change counsellors who were current or retired health or social service professionals (confirmed by author via email) Mode of delivery: Telephone Duration: 14 telephone calls over a 6‐month period (weekly for 2 months, biweekly for 2 months, monthly for 2 months). Content: During the first two calls, caregivers were directed to complete daily activity logs (to establish baseline levels of physical activity) and to set a realistic long‐term exercise goal that specified the type of exercise as well as duration and frequency. They were encouraged to set a goal that consisted of a minimum of 30 minutes of low to moderate intensity aerobic exercise at least 3 times a week, supplemented with stretching and strength training. During subsequent calls, participants set short‐term goals for exercise and a problem‐solving process was used to address barriers to goal attainment. They also received a Health First video featuring spouse caregivers discussing strategies for fitting physical activity into their daily routine as a way to model desired behaviour, a choice of exercise videos, a copy of the booklet “Pep up our Life”, and a Health First workbook that explains each step of the program. Standardisation: Counsellors participated in a day‐long training session to address program fidelity that included opportunities for role play and performance feedback to promote appropriate and accurate delivery of the program. A project manager monitored several calls made by each counsellor to confirm that the intervention was being delivered correctly and uniformly. Comparison group: No intervention/usual care (n = 63).
Outcomes	1. Burden: Objective caregiver burden using the Revised Memory and Behavior Problem Checklist (RMBPC) which assesses upset or burden with the presence of 24 memory and behaviour problems. Possible RMBPC scores range from 0‐24, with higher scores indicating more problem behaviours. Subjective burden using responses in the ‘bother/upset/questions' asked as part of a modified version of the RMBPC Form. Responses ranged on a 5‐point scale from 'not at all' to 'extremely'. Responses were summed for an overall subjective burden score, with possible scores ranging from 0‐96. Higher scores were associated with being more bothered or upset by the care‐recipient’s problem behaviours. 2. Psychological health (depression): The 11‐item Iowa short form of the Center for Epidemiologic Studies Depression Scale (CES‐D). Participants were asked the frequency with which they experienced symptoms in the past week (hardly ever or never, some of the time, or much or most of the time). Possible scores range from 0 to 22; higher scores were associated with more symptoms. 3. Psychological health (stress): Perceived stress was measured with the 14‐item Cohen Perceived Stress Scale. Participants rate the degree to which events in the past month were perceived as stressful using a 5‐point scale ranging from never (0) to very often (4); higher scores indicating higher levels of perceived stress. 4. Health status and well‐being (self‐efficacy): Exercise self‐efficacy was measured by nine items developed for dementia caregivers where participants rated their level of confidence that they could exercise when faced with barriers (e.g. being tired, hectic schedule) using a scale of 1 to 10 (not at all confident to very confident). The ratings were averaged across items for a total exercise self‐efficacy score. Higher scores indicated greater confidence. Self‐efficacy for self‐care was assessed by the single item, “How confident do you feel in being able to take care of yourself?” Response choices ranged from not confident at all to very confident using a 5‐point scale. All outcomes were collected using follow‐up interviews administered at the end of intervention short‐term approximately 6 months and approximately 12 months from baseline.
Notes	For the outcome burden, data from the subjective burden questionnaire was used in our analysis. For the outcome self‐efficacy, the data for self‐efficacy for self‐care was used. Funding source: A grant from the National institute on Aging to the Michigan Alzheimer’s Disease Research Center (p.172). Unpublished data sought via email, author responded and all available data were provided.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to assess
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	Unclear risk	Insufficient information to assess
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	15.9% overall (n = 27) (17 intervention versus 9 control) (p.179)
Selective reporting (reporting bias)	Low risk	All relevant outcomes reported
Other bias	High risk	At baseline, there was a difference between the groups noted in depression scores (intervention 9.4 SD 2.9; control 7.9, SD 2.8) (p.181).