# Running a clinical trial remotely: Lessons learnt from a decentralised multicentre randomised controlled trial evaluating a digital health intervention for Chronic Kidney Disease

## TL;DR

This paper explores the challenges and successes of running a remote clinical trial for a digital health intervention in chronic kidney disease, highlighting lessons learned for future studies.

## Contribution

The study provides insights into recruitment and operational challenges of decentralized clinical trials and identifies strategies to improve future DCTs.

## Key findings

- An invitation flyer via post after a remote clinical appointment was the most successful recruitment method.
- Research staff noted a disparity between expected and actual recruitment rates in DCTs.
- DCTs were perceived as more environmentally friendly and capable of engaging diverse participant groups.

## Abstract

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.

Decentralised clinical trials (DCTs), where some or all parts of the trial happen remotely, are believed to offer a practical approach to test interventions. Our team conducted a multi-centre randomised DCT that tested a digital health intervention. We used digital tools for trial processes and data collection. We interviewed research staff involved in the trial to learn more about their experiences of running a DCT. Our findings suggest that this type of approach has the potential to enable numerous people to take part. We found that the most successful route to invite was by speaking to them about it first, rather than directly sending letters out in the post. Using a DCT design was believed to provide an opportunity to recruit a diverse group of participants, reduce travel for participants, and be more eco-friendly. However, the research staff involved faced some challenges; the lack of direct communication was considered hard, and there were some misconceptions about who could and would be willing to participate, particularly regarding age and digital skills. Our findings have helped us understand more about how to best conduct DCTs and identified factors for consideration when designing future DCTs to improve trial delivery.