Abstract

BackgroundThis protocol describes an ongoing study of the impact of befriending on depression, anxiety and loneliness in older people living in residential aged care facilities in Australia. While systematic reviews of befriending have indicated positive benefits of befriending for people in a range of ages and settings, there have been no randomised controlled trials (RCTs) of befriending for older people living in residential aged care with depression and no studies of the cost effectiveness of befriending in residential aged care facilities (RACFs) in Australia.Methods and analysisWe are conducting a single blind pragmatic RCT comparing two groups of older people living in RACFs, one receiving an intervention consisting of weekly befriending for 4 months from a trained volunteer and the other receiving treatment as usual. Participants undergo eligibility screening for depression (GDS-15 ≥ 4) and cognitive impairment (GPCog ≥ 4) and assessments at three measurement time points: baseline prior to randomisation, 2 months post-baseline and 4 months post-baseline. The primary outcome measure is depression, and secondary outcome measures are anxiety, loneliness, social isolation and quality of life. The economic evaluation will take the form of a cost-utility analysis based on the outcome of quality of life. The primary and secondary outcomes will be analysed using negative binomial and logistic regressions utilizing the Generalised Estimating Equations approach.DiscussionTo our knowledge, this is the first RCT evaluating the effectiveness of befriending on older people with depression living in residential aged care. It is expected that the befriending intervention will reduce the severity of depression symptoms experienced by older people living in residential aged care. If the intervention proves effective it may be incorporated into volunteer training programs and adopted as a way of supporting older people’s mental health.Trial registrationTrial registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR) Number: ACTRN12619000676112, registered 06/05/2019 – retrospectively registered.

Highlights

  • This protocol describes an ongoing study of the impact of befriending on depression, anxiety and loneliness in older people living in residential aged care facilities in Australia

  • Doyle et al BMC Geriatrics (2021) 21:305 (Continued from previous page). To our knowledge, this is the first randomised controlled trials (RCTs) evaluating the effectiveness of befriending on older people with depression living in residential aged care

  • This study protocol presents the design of an ongoing RCT that aims to test the effectiveness of befriending by a volunteer on depression, anxiety and loneliness symptoms in older people living in residential aged care

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Summary

Methods and analysis

Based on the average effect size of 0.27 for short term befriending outcome studies of mostly older adults with depression in primary care settings, it is estimated that with data collection spread over a three-year period, and allowing for a higher than usual dropout rate of 20% given low life expectancy among RACF residents, recruiting 272 participants per study arm (total of 544 participants) would achieve 80% power, with a statistical significance of 0.05. Data collection and management Data collection is performed by blinded research assistants trained to administer the outcome measures in a structured interview, with the exception of some data available from the resident’s RACF records, which is provided by the RACF staff. Colaizzi’s phenomenological data analysis steps will be used to describe the phenomena experienced by the participants and by the volunteers [40, 41]

Discussion
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