Running a clinical trial remotely: Lessons learnt from a decentralised multicentre randomised controlled trial...

Decentralised clinical trials (DCTs) are a potentially efficient and cost-effective way of delivering research trials. My Kidneys & Me, a self-management digital health intervention for chronic kidney disease, was evaluated in a multi-centre randomised DCT (SMILE-K) (ISRCTN18314195). This study aims to evaluate recruitment outcomes and research staff experiences of delivering the SMIKE-K DCT, to inform the design of future DCTs. SMILE-K used fully remote trial processes, including online outcome measure collection. Recruitment and retention data were collected, including numbers invited, recruited, and completing outcome measures, and methods of invitation and consent. Quantitative data were analysed descriptively. Following trial recruitment, semi-structured interviews were conducted with research staff at external recruiting sites to explore their perspectives and experiences of remote trial processes. Qualitative data were analysed using thematic analysis. 420 participants were recruited to SMILE-K. The median time from expression of interest to consent was 1 day (range:0-100), and from consent to randomisation was 6 days (range:0-197). Thirteen research staff were interviewed. Six themes were identified: 'discordance between perceptions and experiences of recruiting participants', 'reallocation of available resources across research studies', 'more environmentally friendly', 'onus on participants', 'engaging disadvantaged groups of participants', and 'future considerations to improve recruitment'. Results suggest that a DCT design can reach a high number of eligible participants. An invitation flyer via post after a remote clinical appointment was the most successful method of recruitment. Research staff felt DCTs provided opportunities for a diverse and representative population to participate and study procedures were environmentally friendly; however, consideration must be given to the factors that may affect recruitment and participation. Our research highlights a clear disparity between the expected recruitment rate and the reality of recruiting for DCTs, with research staff indicating they faced unanticipated challenges during the process. We outline factors for consideration when designing and delivering DCTs.