School of Nursing, University of Minnesota, Minneapolis, USA.
Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, USA.
J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):547-553. doi: 10.1093/gerona/glab092.
Recruiting older adults with Alzheimer's disease (AD) dementia into clinical trials is challenging requiring multiple approaches. We describe recruitment and screening processes and results from the Functional Improvement from Aerobic Training in Alzheimer's Disease study (FIT-AD Trial), a single-site, pilot randomized controlled trial testing the effects of a 6-month aerobic exercise intervention on cognition and hippocampal volume in community-dwelling older adults with mild-to-moderate AD dementia.
Ten recruitment strategies and a 4-step screening process were used to ensure a homogenous sample and exercise safety. The initial target sample was 90 participants over 48 months which was increased to 96 to allow those in the screening process to enroll if qualified. A tertiary analysis of recruitment and screening rates, recruitment yields and costs, and demographic characteristics of participants was conducted.
During the 48-month recruiting period, 396 potential participants responded to recruitment efforts, 301 individuals were reached and 103 were tentatively qualified. Of these, 67 (69.8%) participants completed the optional magnetic resonance imaging and 7 were excluded due to abnormal magnetic resonance imaging findings. As a result, we enrolled 96 participants with a 2.92 screen ratio, 2.14 recruitment rate, and 31.9% recruitment yield. Referrals (28.1%) and Alzheimer's Association events/services (21.9%) yielded over 49% of the enrolled participants. Total recruitment cost was $38 246 or $398 per randomized participant.
A multiprong approach involving extensive community outreach was essential in recruiting older adults with AD dementia into a single-site trial. For every randomized participant, 3 individuals needed to be screened. Referrals were the most cost-effective recruitment strategy. Clinical Trials Registration Number: NCT0194550.
招募患有阿尔茨海默病（AD）痴呆症的老年人参与临床试验具有挑战性，需要采用多种方法。我们描述了功能改善来自有氧运动在阿尔茨海默病研究（FIT-AD 试验）的招募和筛选过程和结果，这是一项单站点、试点随机对照试验，测试了 6 个月有氧运动干预对轻度至中度 AD 痴呆症的认知和海马体积的影响。
采用 10 种招募策略和 4 步筛选流程，确保样本同质和运动安全。最初的目标样本为 90 名参与者，为期 48 个月，增加到 96 名，以允许筛选过程中符合条件的人员参加。对招募率和筛选率、招募产出和成本以及参与者的人口统计学特征进行了三级分析。
在 48 个月的招募期间，396 名潜在参与者对招募工作做出了回应，301 人被联系到，103 人初步合格。其中，67 名（69.8%）参与者完成了可选的磁共振成像检查，7 名因磁共振成像异常而被排除。因此，我们招募了 96 名参与者，筛检率为 2.92，招募率为 2.14%，招募率为 31.9%。转诊（28.1%）和阿尔茨海默病协会的活动/服务（21.9%）产生了超过 49%的入组参与者。总招募费用为 38246 美元，或每位随机参与者 398 美元。
一种多管齐下的方法，包括广泛的社区外展，对于在一个单站点试验中招募患有 AD 痴呆症的老年人是必不可少的。每一个随机参与者，需要筛选 3 个人。转诊是最具成本效益的招募策略。临床试验注册号：NCT0194550。
