Opportunities and challenges of delivering digital clinical trials: lessons learned from a randomised controlled trial of an online behavioural intervention for children and young people

Abstract

Background Despite being the gold standard of research to determine effectiveness, randomised controlled trials (RCTs) often struggle with participant recruitment, engagement and retention. These issues may be exacerbated when recruiting vulnerable populations, such as participants with mental health issues. We aimed to update understanding of the scope of these problems in trials of health technology and identify possible solutions through reflecting on experiences from an exemplar trial (Online Remote Behavioural Intervention for Tics; ORBIT). Method We extracted anonymised data on recruitment, retention and requests for more funding and time from trials funded by the largest funder of health technology trials in the UK (the National Institute of Health Research Health Technology Assessment) between 2010 and 2020, and compared these with data from a recent, successful trial (ORBIT). ORBIT aimed to assess the clinical- and cost-effectiveness of blended online and human behavioural therapy for tics in young people. Many of the trial procedures, including recruitment, the intervention and data collection, were undertaken online. Results Data were extracted on 51 trials conducted between 2010 and 2020. Sixty per cent of trials failed to reach their original recruitment target and only 44% achieved their follow-up in the specified time frame. In contrast, ORBIT recruited to target and achieved 90% follow-up. We posit that these achievements are related to (a) judicious use of digital technology for trial procedures and (b) adequate numbers of highly trained and motivated trial staff. We provide details of both these to help other research teams plan and cost for successful trials. Conclusion An approach combining human and online methods may be advantageous in facilitating trial delivery, particularly in paediatric mental health services. Given the importance of successful clinical trials in advancing healthcare delivery and the waste of human and economic resources associated with unsuccessfully delivered trials, it is imperative that trials are appropriately costed and future research focusses on improving trial design and delivery. Trial registration The ORBIT trial is registered with ISRTCN (ISRCTN70758207) Registered on March 20, 2018. and ClinicalTrials.gov (NCT03483493). Registered on March 30, 2018.

Pilot randomised controlled trial of a remotely delivered online intervention for adolescent mental health problems in India: lessons learned about low acceptability and feasibility during the COVID-19 pandemic

“…42,43 Finally, judicious use of technology for trial procedures and the use of hybrid approaches, which include in-person interaction at school, may help to conduct evaluations. 44 In conclusion, findings from this pilot trial are inconclusive about whether the key barriers to adolescent participation were a result of difficulties accessing online research procedures, intervention delivery or a combination of both, which may have been exacerbated by COVID-19 pandemic conditions. More studies with this age group and in similar settings are needed to establish the generalisability of these findings.…”

“… 42 , 43 Finally, judicious use of technology for trial procedures and the use of hybrid approaches, which include in-person interaction at school, may help to conduct evaluations. 44 …”

Digital Formats for Community Participation in Health Promotion and Prevention Activities: A Scoping Review

“…On the other side, higher drop-out rates and a lack of evidence on the effectiveness of digital interventions have been reported ( 42 , 51 ). Additionally, according to Hall et al ( 52 ), aspects of “poor technology skills, interfaces that are not user-friendly, concerns around data security, and a lack of support from healthcare professionals” should be considered when implementing digital interventions.…”

Engagement With and Acceptability of Digital Media Platforms for Use in Improving Health Behaviors Among Vulnerable Families: Systematic Review

“…Another important consideration is the disparities that exist in access to and use of digital communication technology and varying levels of digital health literacy among low-income groups, immigrants to the United States, and people with lower educational attainment (known as the "digital divide") [17,[56][57][58]. The studies in this sample generally avoided issues related to access by excluding participants without a mobile phone or, in the case of 6 studies, providing a mobile phone with a cellular or data plan to study participants.…”