Evaluation of the feasibility of a RCT of Empowered Conversations: a training to enhance relationships and communication between family carers and people living with dementia

Award Number
NIHR201093
Programme
Research for Patient Benefit
Status / Stage
Active
Dates
10 February 2021 -
10 January 2023
Duration (calculated)
01 years 11 months
Funder(s)
NIHR
Funding Amount
£255,109.00
Funder/Grant study page
NIHR
Contracted Centre
Greater Manchester Mental Health NHS Foundation Trust
Contracted Centre Webpage
Principal Investigator
Dr Lydia Morris
PI Contact
lydia.morris@manchester.ac.uk
PI ORCID
0000-0002-3337-8144,0000-0002-5697-1784
Principal Investigator
Dr Warren Mansell
WHO Catergories
Economic Impact of Dementia
Methodologies and approaches for risk reduction research
Disease Type
Dementia (Unspecified)

CPEC Review Info
Reference ID21
ResearcherReside Team
Published12/06/2023

Data

Award NumberNIHR201093
Status / StageActive
Start Date20210210
End Date20230110
Duration (calculated) 01 years 11 months
Funder/Grant study pageNIHR
Contracted CentreGreater Manchester Mental Health NHS Foundation Trust
Contracted Centre Webpage
Funding Amount£255,109.00

Abstract

Is it feasible to evaluate Empowered Conversations, a face-to-face course for informal carers of people living with dementia, within a multi-centre RCT? Background: Almost one in two informal carers of people with dementia reports clinically significant depression or anxiety. Challenges to communication are a substantial source of frustration, low mood and stress for both people living with dementia and their carers. Improved communication can enhance relationships and support people living with dementia to feel connected and understood. Extensive literature review and scoping identified a need for an interactive training that supports carers and provides them with tools to cope with the emotional challenges they experience, as well as with more specific communication skills to improve person-to-person connection. We have developed a training course for informal carers of people living with dementia: Empowered Conversations . Initial qualitative findings indicate that it improves the relationship between carers and those they support, and enables carers to feel less stressed and more competent in their caring role. Carers can be supporting someone living with dementia for over 10-years and Empowered Conversations can improve carer well-being, reduce relational stress and increase positive connection. This has the potential to prevent relationship breakdown and admission into residential care for the person living with dementia. Aims and Objectives: The key aim is to establish the feasibility of a multi-centre trial of Empowered Conversations compared to Treatment As Usual (TAU). The main objectives are to: Establish recruitment pathways and facilitators/barriers to recruitment. Investigate potential effectiveness on a range of outcome and process measures. Establish the optimum way of evaluating cost-effectiveness and obtain preliminary economic data to estimate potential cost-effectiveness. Meaningfully involve carers and people with dementia; identify Patient and Public Involvement opportunities in the feasibility and multi-site RCT. Methods: Participants will be informal carers for people with dementia. A mixed methods approach will be used. Work package 1 will be a pragmatic data-collector blind parallel two-group RCT to acquire feasibility data. Participants will be randomised into the Empowered Conversations training-intervention or TAU waitlist control. Those in the TAU arm will receive Empowered Conversations at the end of their follow-up, assuming they still wish to receive it. Randomisation will be performed with a 2:1 allocation, in favour of the immediate intervention arm. Self-report measures from the perspective of carers will be collected at baseline appointment and 6-month follow up. Cost-effectiveness data will also be collected. Work package 2 will be a qualitative study. Twenty to 25 Empowered Conversations participants will be interviewed using a semi-structured interview schedule. The interviews will focus upon the decision making process around taking part in the study, whether there is an optimum time and mechanism to offer people such an intervention and whether there were any unmet needs after Empowered Conversations. Impact: The findings of this study will form the basis of a definitive multi-centre RCT to establish effectiveness and cost-effectiveness of Empowered Conversations, providing feasibility is established. There is a substantial need for evidence-based interventions for informal carers that enhance relationships and well-being.

Aims

The key aim is to establish the feasibility of a multi-centre trial of Empowered Conversations compared to Treatment As Usual (TAU). The main objectives are to: Establish recruitment pathways and facilitators/barriers to recruitment. Investigate potential effectiveness on a range of outcome and process measures. Establish the optimum way of evaluating cost-effectiveness and obtain preliminary economic data to estimate potential cost-effectiveness.