Submitted to: Journal of Gerontology Medical Science
Publication Type: Peer reviewed journal
Publication Acceptance Date: 3/26/2013
Publication Date: 12/1/2013
Citation: Marsh, A.P., Lovato, L.C., Glynn, N.W., Kennedy, K., Castro, C., Domanchuk, K., Mcdavitt, E., Rodarte, R., Marsiske, M., Mcgloin, J., Groessl, E.J., Pahor, M., Guralnik, J.M. 2013. Lifestyle interventions and independence for elders study: Recruitment and baseline characteristics. Journal of Gerontology Medical Science. 68(12):1549-1558. Interpretive Summary: The Lifestyle Interventions and Independence Study for Elders (LIFE) Study is multi-center trial comparing a physical activity program to a health education program in inactive, older adults. The goal was to enroll a total of 1600 older adults age 70-89 across eight sites at high risk of developing the inability to walk a quarter of a mile. Recruitment of this population of older adults into a clinical trial is a challenging process, particularly in long term trials with behavioral interventions. The purpose of this work is to describe the recruitment methods, yields, and costs as well as include baseline characteristics of the participants. The recruitment period lasted 21 months and all recruitment goals were met. Direct mailings of brochures and letters were found to be the most productive method of recruitment accounting for 57.9% of participants enrolled following by print advertisements, television and radio advertisements, referrals, and events such as health fairs. Direct costs of recruitment methods totaled $840 per enrolled participant. There are additional staff and transportation costs associated with the recruitment process. A total of 14,812 individuals were telephone screened resulting in 1,635 (67.2% women and 21.0% minority) participants enrolled in the study. The most common reasons for exclusion were regular physical activity, health reasons, or self-reported physical disability. These findings show the feasibility in recruiting this population and the most efficient, cost-effective methods of recruitment.
Technical Abstract: 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 70–89 years, who were at high risk for mobility disability (scoring less than or equal to 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 less than or equal to 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.