Decentralised clinical trials: How the iSupport for Dementia Carers study identifies, recruits and communicates with unpaid carers across Britain

The iSupport for Dementia Carers study opened in January 2021, at a time of changing COVID-19 lockdown laws. Research Assistants used remote research methods to screen, take consent and assess participants, and achieved the study’s target of recruiting 352 unpaid carers to the Randomised Controlled Trial. Participants received either online access to iSupport (an e-health intervention for dementia carers), or a booklet about caring for someone living with dementia, and were followed-up at 3-months and 6-months post-baseline. Research Assistants were working from home and were blinded to group allocation.

Participant and Public Involvement (PPI) feedback led to the appointment of an “e-coach”, who emailed all participants post-randomisation as a point of contact. The e-coach was unblinded and contacted intervention participants twice more to offer technical support, resolve issues and record general comments on the study. PPI feedback also suggested online meeting software (e.g. Zoom) would be preferred over telephone assessments – including for qualitative interviews – as “it’s better to see people”.

A Join Dementia Research (JDR) database was set-up with three “sites”, sorted by volunteer post-codes. This helped streamline recruitment, as country of residence was a stratification variable for the randomisation system. Our project partners (Carers Trust and Alzheimer Scotland), other organisations, and social media channels also promoted self-referral, and in total 2,326 potential participants were screened over a 16-month period. All contact attempts were logged by Research Assistants, and reasons for declining or being ineligible were compiled with anonymised demographic information to analyse inequalities or barriers to research participation.

Study procedures and overall progress were monitored on a regular basis, which required frequent meetings online to ensure confidential and accurate data management. The decentralised nature of the study allowed for greater responsibility sharing without geographic constraints, and the remote research methods were safe and convenient for participants.