Title: 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
Funder: Department of Health and Social Care

Abstract: Research question: 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.

Lay abstract: Background There are 700,000 family and informal carers for people living with dementia in the UK alone. Sixty-four percent of informal carers in England say they have limited support for the range of psychological and social needs they experience. About 40% of informal carers of people with dementia have high levels of depression or anxiety. It can be difficult to keep communicating well due to some of the thinking and memory changes that arise when someone is living with dementia. This can lead to frustration, low mood and stress for both people living with dementia and their carers. There is an urgent need to reduce the distress of carers and support them in their caring role. The Empowered Conversations course has been designed to enable carers to establish and maintain good relationships with those they support. Course facilitators are mainly current or previous carers and are trained to provide specific communication techniques, ways of managing conflicts and working with difficult emotions. The course has been developed at the University of Salford in partnership with an organisation called Six Degrees. The course is made up of two-and-a-half-hour sessions run over 6-weeks. Aims and study design. The course has been tried out over the last four years and changes made to it. Feedback from informal carers indicates it is in an optimum form and so we are ready to test it further in a large trial. Before we can do this we need to do a smaller feasibility trial to find out whether such a larger trial is possible. This is important because a big trial will help us identify if our course works, but trials are expensive and unhelpful if they go wrong. Through our feasibility study we want to find out if carers are willing to take part in a trial. We want to make sure that carers would be willing to have an only 66% chance of receiving the course straight away. The remaining 33% of carers would be offered the course 6-months later. We also want to be sure that our design is good enough to identify any improvement in carers well-being, relationships and communication. We will examine whether measures of these can provide useful information about any changes experienced. We will ask carers to take part in a one-to-one interview about their experiences of the course. Patient and public involvement (PPI). We have worked closely with PPI representatives in the two studies leading up to this one and have designed this application during a workshop with PPI advisers. One of these advisers will be on our study Steering Group and will co-lead PPI in our study. This PPI representative has helped us develop this summary.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: NEUROLOGICAL