Abstract
BackgroundRandomized controlled trials (RCTs) provide the highest level of scientific evidence, but successful participant recruitment is critical to ensure the external and internal validity of results. This study describes the strategies associated with recruiting older adults at increased falls risk residing in retirement villages into an 18-month cluster RCT designed to evaluate the effects of a dual-task exercise program on falls and physical and cognitive function.MethodsRecruitment of adults aged ≥65 at increased falls risk residing within retirement villages (size 60–350 residents) was initially designed to occur over 12 months using two distinct cohorts (C). Recruitment occurred via a three-stage approach that included liaising with: 1) village operators, 2) independent village managers, and 3) residents. To recruit residents, a variety of different approaches were used, including distribution of information pack, on-site presentations, free muscle and functional testing, and posters displayed in common areas.ResultsDue to challenges with recruitment, three cohorts were established between February 2014 and April 2015 (14 months). Sixty retirement villages were initially invited, of which 32 declined or did not respond, leaving 28 villages that expressed interest. A total of 3947 individual letters of invitation were subsequently distributed to residents of these villages, from which 517 (13.1%) expressions of interest (EOI) were received. Across three cohorts with different recruitment strategies adopted there were only modest differences in the number of EOI received (10.5 to 15.3%), which suggests that no particular recruitment approach was most effective. Following the initial screening of these residents, 398 (77.0%) participants were deemed eligible to participate, but a final sample of 300 (58.0% of the 517 EOI) consented and was randomized; 7.6% of the 3947 residents invited. Principal reasons for not participating, despite being eligible, were poor health, lack of time and no GP approval.ConclusionThis study highlights that there are significant challenges associated with recruiting sufficient numbers of older adults from independent living retirement villages into an exercise intervention designed to improve health and well-being.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12613001 161718. Date registered 23rd October 2013.
Highlights
Randomized controlled trials (RCTs) provide the highest level of scientific evidence, but successful participant recruitment is critical to ensure the external and internal validity of results
This study was an 18-month, community-based, cluster RCT in which older adults residing in retirement villages, who were at a high risk of falling, were randomly allocated to 1) an exercise program involving dual-task functional power training (DT-FPT), or 2) a usual care control group
This study highlights that there were significant challenges associated with recruiting operators, managers, and residents of independent living retirement villages into an exercise intervention trial promoted to improve overall health, mobility and well-being
Summary
The aim of this report is to describe the strategies, efficacy, pitfalls and successes associated with recruiting 300 older adults residing in retirement communities at increased risk for falling, into an 18-month RCT referred to as the Physical and Cognitive Exercise Intervention Trial (PACE-IT)
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