Lifestyle Interventions and Independence for Elders Study: Recruitment and Baseline Characteristics
Lifestyle Interventions and Independence for Elders Study: Recruitment and Baseline Characteristics
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DOI：
10.1093/gerona/glt064
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发表时间：
2013-12-01
影响因子：
5.1
通讯作者：
Guralnik, Jack M.
中科院分区：
文献类型：
--
作者：
Marsh, Anthony P.;Lovato, Laura C.;Guralnik, Jack M.
招募老年人参与涉及行为干预的长期临床试验是一项重大挑战。生活方式干预和老年人独立性（LIFE）研究是一项III期多中心随机对照多地点试验，旨在比较中等强度体力活动计划与成功的老龄化健康教育计划对主要活动障碍发生率的影响（不能行走400米）在久坐的成年人年龄70 - 89岁，谁是在高风险的流动性残疾招募方法、产量、效率和成本与参与者基线特征的总结一起描述。在21个月的招募期内，共进行了14，812次电话筛选; 1，635名参与者被随机分组（67.2%为女性，21.0%为少数民族，44.7%的人的短期身体表现为7分）。在电话筛选的参与者中，37.6%的人被排除在外，主要是因为经常参加体育活动，健康排除或自我报告的行动不便。直接邮寄是最有效的招募策略（59.5%的随机参与者）。招募成本为每名随机参与者840美元。产量因性别和短期体能测试组合而异。由于招募速度加快，我们在招募期间的受试者随访时间比预期多11%。LIFE研究达到了所有招募基准。批量邮寄是从不同地理区域招募高风险社区居住老年人（包括少数民族）进行长期行为试验的有效方法。
Recruitment of older adults into long-term clinical trials involving behavioral interventions is a significant challenge. The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled multisite trial, designed to compare the effects of a moderate-intensity physical activity program with a successful aging health education program on the incidence of major mobility disability (the inability to walk 400 m) in sedentary adults aged 7089 years, who were at high risk for mobility disability (scoring 9 on the Short Physical Performance Battery) at baseline.Recruitment methods, yields, efficiency, and costs are described together with a summary of participant baseline characteristics. Yields were examined across levels of sex, race and ethnicity, and Short Physical Performance Battery, as well as by site.The 21-month recruiting period resulted in 14,812 telephone screens; 1,635 participants were randomized (67.2% women, 21.0% minorities, 44.7% with Short Physical Performance Battery scores 7). Of the telephone-screened participants, 37.6% were excluded primarily because of regular participation in physical activity, health exclusions, or self-reported mobility disability. Direct mailing was the most productive recruitment strategy (59.5% of randomized participants). Recruitment costs were $840 per randomized participant. Yields differed by sex and Short Physical Performance Battery. We accrued 11% more participant follow-up time than expected during the recruitment period as a result of the accelerated recruitment rate.The LIFE Study achieved all recruitment benchmarks. Bulk mailing is an efficient method for recruiting high-risk community-dwelling older persons (including minorities), from diverse geographic areas for this long-term behavioral trial.