Institute for Physical Activity and Nutrition, Deakin University, 221 Burwood Highway, Burwood, VIC, 3125, Australia.
Australian Institute for Musculoskeletal Sciences (AIMSS), St. Albans, Melbourne, Australia.
BMC Med Res Methodol. 2018 Dec 20;18(1):173. doi: 10.1186/s12874-018-0633-4.
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 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.
Recruitment 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.
Due 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.
This 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.
Australian New Zealand Clinical Trials Registry: ACTRN12613001 161718 . Date registered 23rd October 2013.
随机对照试验（RCT）提供了最高水平的科学证据，但成功招募参与者对于确保结果的外部和内部有效性至关重要。本研究描述了与招募居住在退休村、有较高跌倒风险的老年人有关的策略，这些老年人参与了一项为期 18 个月的群组 RCT，旨在评估双重任务运动计划对跌倒、身体和认知功能的影响。
最初设计在 12 个月内通过两个不同的群组（C）招募年龄在 65 岁以上、有较高跌倒风险、居住在退休村（60-350 名居民）的成年人。招募通过三阶段方法进行，包括与以下方面联系：1）村庄运营商，2）独立的村庄经理，以及 3）居民。为了招募居民，使用了多种不同的方法，包括分发信息包、现场演示、免费肌肉和功能测试以及在公共区域张贴海报。
由于招募方面的挑战，于 2014 年 2 月至 2015 年 4 月期间设立了三个群组（14 个月）。最初邀请了 60 个退休村，但其中 32 个拒绝或未回复，剩下 28 个表示有兴趣。随后向这些村庄的居民分发了 3947 封个人邀请信，其中有 517 人（13.1%）表示有兴趣（EOI）。采用不同的招募策略的三个群组之间收到的 EOI 数量只有适度的差异（10.5%至 15.3%），这表明没有特定的招募方法是最有效的。对这些居民进行初步筛选后，有 398 人（77.0%）被认为有资格参与，但最终有 300 人（517 名 EOI 的 58.0%）同意并被随机分配；邀请的 3947 名居民中有 7.6%。尽管有资格参加，但不参加的主要原因是健康状况不佳、缺乏时间和没有 GP 批准。
本研究强调，从独立生活的退休村招募足够数量的老年人参加旨在改善健康和福祉的锻炼干预措施存在重大挑战。
澳大利亚和新西兰临床试验注册中心：ACTRN12613001 161718。注册日期：2013 年 10 月 23 日。
