Novel recruitment and retention strategies for sarcopenia trials: learning from the MET-PREVENT randomised controlled trial

BackgroundRecruiting and retaining participants in sarcopenia trials is challenging due to barriers in diagnosis, case-finding, exclusion criteria, frailty and drop-out. We describe and evaluate processes used by the MET-PREVENT randomised controlled trial to improve recruitment and retention. MethodsMET-PREVENT was a two-centre, double-blinded, placebo-controlled trial examining the efficacy of metformin in patients with probable sarcopenia and either pre frailty or frailty. A telephone pre-screening step used the SARC-F questionnaire to identify those at risk of sarcopenia. The study was designed to maximise inclusion; and all study assessments could be conducted in participants homes or at a clinical research facility according to participant preference. Outcome measures were chosen to be simple and quick to collect with low burden to participants. Data on absolute numbers approached and randomised from a range of recruitment channels were analysed along with percentage conversion from approach to randomisation. The relationship between baseline factors at prescreening and conversion to randomisation (age, sex, use of walking aids, SARC-F score) was analysed to evaluated. Results1630 people were approached and 268 people expressed interest in participation - of whom 214/268 (80%) underwent telephone pre-screening and 112/214 (42%) progressed to face-to-face screening.72/112 (64%) were randomised and 70/72 (97%) completed the trial. Recruitment took place from secondary care geriatric medicine clinics and via primary care mailshots; routes where patients had already had muscle strength recorded showed greater recruitment efficiency than those that did not. At face-to-face screening, SARC-F scores of 1 to 4 showed lower efficiency of recruitment compared to 5+ (49/82 [60%] vs 23/30 [77%] respectively) but accounted for most recruits (49/72 [68%]); age and sex were not associated with differences in recruitment. The majority (148/214 [69%]) of potential participants at prescreening expressed a preference for home visits; 101/112 (90%) undertook the screening visit at home and 45/72 (63%) of those randomised undertook either or both outcome visits at home. ConclusionA package of innovations in participant identification, recruitment processes and study visits enabled recruitment to target and the achievement of very high retention rates for a condition where it has traditionally been challenging to conduct clinical trials. Trial registrationISRCTN29932357