Abstract

Background
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 informal (family) care partners of people living with dementia. The two key feasibility objectives were to establish whether recruitment levels and retention to follow-up were sufficient for a multi-centre evaluation trial to be feasible. Secondary objectives were as follows: to estimate potential effectiveness on a range of candidate primary outcome measures and their standard deviations; to identify the most appropriate primary outcome measure for a multi-centre evaluation trial; to obtain additional evidence regarding proof of concept; to establish the optimum way of evaluating cost-effectiveness in the evaluation trial.

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 6 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 the feasibility of progressing to an evaluation trial of EC. Recruitment was at 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.

Trial Registration
ISRCTN15261686; Registered 02/03/2022 https://www.isrctn.com/ISRCTN15261686