Conducting a randomised controlled trial of a psychosocial intervention for adolescents with type 1 diabetes during COVID-19: recommendations to overcome the challenges complicated by inconsistent public health guidelines on research

Abstract

AbstractSince the beginning of the COVID-19 pandemic, there has been very little guidance in Ireland and abroad, around the conduct of research, and randomised controlled trials (RCTs) in particular. This has led to inconsistent interpretations of public health guidelines for the conduct of research in hospitals. Consequently, challenges have arisen for researchers conducting RCTs, in relation to recruitment and retention. These challenges are amplified for RCTs of psychosocial interventions, where communication and physical contact play a major role in administering the RCT. Therefore, learning from other research studies is important. This study addresses the challenges in administering an RCT of a psychosocial intervention in two paediatric outpatient diabetes clinics in Dublin Ireland, including recommendations to overcome these. Recommendations include the following: (1) recognise research as an essential service; (2) hospital management should implement guidelines to ensure a consistent approach to the conduct of research during pandemics; (3) ensure that there is a mechanism for the provision of clear and effective communication before the clinic visit with patients, to reassure them and gain their trust; and (4) trial managers should make time to check in with their team every day, as they would do if they were in the office.