Abstract
BackgroundThe difficulty of recruiting older people to clinical trials is well described, but there is limited information about effective ways to screen and recruit older people into trials, and the reasons for their reluctance to enrol. This paper examines recruitment efforts for a community-based health intervention study that targeted older adults.MethodsOne year randomized control trial. Undernourished men and women, aged ≥ 65 years and living independently in the community were recruited in three Australian states. Participants were allocated to either oral testosterone undecanoate and high calorie oral nutritional supplement or placebo medication and low calorie oral nutritional supplementation. Hospital admissions, functional status, nutritional health, muscle strength, and other variables were assessed.Results4023 potential participants were identified and 767 were screened by a variety of methods: hospital note screening, referrals from geriatric health services, advertising and media segments/appearances. 53 participants (7% of total screened) were recruited. The majority of potentially eligible participants declined participation in the trial after reading the information sheet. Media was the more successful method of recruiting, whereas contacting people identified by screening a large number of hospital records was not successful in recruiting any participants.ConclusionRecruitment of frail and older participants is difficult and multiple strategies are required to facilitate participation.Trial registrationAustralian Clinical Trial Registry: ACTRN 12610000356066 date registered 4/5/2010
Highlights
The difficulty of recruiting older people to clinical trials is well described, but there is limited information about effective ways to screen and recruit older people into trials, and the reasons for their reluctance to enrol
Older people, in particular the frail, are difficult to enrol in clinical research studies [2]
In this paper we describe the challenges, process and outcome of recruiting older people at-nutritional risk to a multi-centre, community based, randomized control trial looking at the efficacy of interventions that include a nutritional supplement and pharmaceutical agent [13]
Summary
Enrolment rate Four thousand and twenty three potential participants were identified The majority of these (3592 [89%]) were identified by case note review in New South Wales, and of these 336 met initial inclusion criteria regarding age and co-existent medical conditions, and were sent written material about the study. These subjects and an additional 431, largely identified in response to newspaper advertisements, radio and TV appearances by the investigators, and in a few cases after referral by friends or others, were contacted for screening by phone (total n = 767). No subjects were recruited as a result of case note reviews
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