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Background <p>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.</p> Methods <p>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.</p> Results <p>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%–&lt;80%; green ≥ 80% retention).</p> Conclusion <p>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.</p> Trial Registration <p>ISRCTN15261686; Registered 02/03/2022 <a href="https://www.isrctn.com/ISRCTN15261686">https://www.isrctn.com/ISRCTN15261686</a></p>

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A feasibility randomised controlled trial of Empowered Conversations: training family carers to enhance their relationships and communication with people living with dementia

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月2日

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  • Lydia Morris,
  • Cassie Eastham,
  • Chris Sutton,
  • Yeliz Prior,
  • Yvonne Sylvestre,
  • Gemma Shields,
  • John Keady,
  • Cathy Riley,
  • Mal Walters,
  • Warren Mansell

摘要

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