Dataset: Empowered Conversations feasibility trial

Objectives: The primary objective of this UK-based trial was to investigate the feasibility of conducting a multi-centre randomised controlled evaluation trial of Empowered Conversations (EC). EC is a 6-session group psychosocial intervention for family / informal care partners of people living with dementia.

Methods: The feasibility trial used a pragmatic data-collector blind parallel two-group RCT design with two arms (EC intervention plus treatment as usual, and treatment as usual waitlist control). There was a 2:1 allocation in favour of the EC arm. Participants completed baseline outcome measures including measures of their psychological health, quality of life and service use. These were repeated after six-months.

Results: Seventy-five care partners were recruited. The average number of people randomised per month was 8.9, consistent with the pre-specified average recruitment rate of 6 to 10 carers per month sufficient for proceeding to a multi-centre trial. A total of 58 (77%) participants were retained at 6 months follow up meeting the amber stop-go criterion (65%–<80%; green ≥80% retention).

Conclusion: The trial indicated feasibility of progressing to an evaluation trial of EC. Recruitment was a sufficient level for a multi-centre trial across three proposed sites. Retention to follow-up was close to the green criterion, and ways of increasing retention in the evaluation trial have been identified.