Trial of Empowered Conversations dementia carer training
| ISRCTN | ISRCTN15261686 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15261686 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 301042 |
| Protocol serial number | IRAS 301042, CPMS 51659 |
| Sponsor | University of Manchester |
| Funder | National Institute for Health Research |
- Submission date
- 25/02/2022
- Registration date
- 02/03/2022
- Last edited
- 10/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
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. It can be difficult to keep communicating well due to 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.
The six-session online Empowered Conversations course is designed to enable carers to establish and maintain good communication and relationships with those they support. Course facilitators are trained to provide specific communication techniques, ways of managing conflicts and working with difficult emotions.
The course has been tried out over the last 4 years and changes have been made. Feedback from informal carers indicates it is in an optimum form and the researchers are ready to test it further in a large trial. Before they do this, they need to do a smaller ‘feasibility’ trial to check whether such a larger trial is possible. This is important because a big trial will help identify if the course works, but trials are expensive and unhelpful if they go wrong. This ‘feasibility’ trial will check several things. The researchers want to make sure that carers would be willing to have an only 66% chance of receiving the course straight away, because it is essential to have a comparison group. The remaining 33% of carers would be offered the course 6 months later. The researchers want to ensure that the design is good enough to identify any improvement in carers’ well-being,
relationships and communication. They will also ask carers to take part in a one-to-one interview about their experiences of the course.
Who can participate?
Carer participants will be included if they live within the Greater Manchester area and are informally caring for someone living with dementia
What does the study involve?
Participants are randomly allocated to the Empowered Conversations training intervention (plus treatment as usual), or the treatment as usual (TAU) waitlist control group. Empowered Conversations is a six-session online course and a psychosocial intervention. Carer self-report measures will be analysed at the start of the study and at a 6-month follow-up. Cost-effectiveness data will also be collected. Those in the TAU group will receive the Empowered Conversations training intervention at the end of their follow-up, assuming they still wish to receive it.
What are the possible benefits and risks of participating?
Participants will attend the Empowered Conversations course with other people in a caring relationship with a person living with dementia. These courses have been found to be supportive and enjoyable. However, talking about caring experiences could be upsetting. The research and facilitator team will support participants if they feel distressed. There are no expected risks to taking part in the research activities (questionnaires and interviews). Potential benefits to carers are through attending the course. Initial evidence indicates that Empowered Conversations can improve stress levels and communication of care partners and this in turn may help the person living with dementia that you are supporting. It is hoped that the findings of the overall study will be useful in evaluating and improving access to Empowered Conversations.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
October 2021 to August 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Cassie Eastham
cassandra.eastham@gmmh.nhs.uk
Contact information
Public
Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
| Phone | +44 (0)7920451062 |
|---|---|
| cassandra.eastham@gmmh.nhs.uk |
Principal investigator
Division of Psychology and Mental Health
School of Health Sciences
University of Manchester
2nd Floor Zochonis Building
Brunswick Street
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 306 0400 |
|---|---|
| lydia.morris@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional single-blind randomized controlled feasibility trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of the feasibility of a randomized controlled trial of Empowered Conversations: a training to enhance relationships and communication between family carers and people living with dementia |
| Study objectives | The primary aim is to establish the feasibility of examining Empowered Conversations (EC) within a multi-centre randomized controlled trial (RCT). The study has the following key objectives to: 1. Establish recruitment pathways 2. Identify facilitators/barriers to recruitment. This will include specifically examine whether the online format presents any barriers to under-served, or other, groups accessing the trial. 3. Estimate retention levels and response rates to questionnaires 4. Obtain additional evidence regarding proof of concept 5. Estimate potential effectiveness on a range of candidate primary outcome measures, and their standard deviations (SDs) 6. Identify the most appropriate primary outcome measure for a multi-centre effectiveness trial 7. Establish the optimum way of evaluating the cost-effectiveness 8. Involve carers and people living with dementia in key decisions about the study and explore opportunities for Patient and Public Involvement and Engagement (PPIE) in the multi-site RCT |
| Ethics approval(s) | Approved 23/02/2022, Welsh Research Ethics Committee 2 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2920 230457, +44 (0)7787 371748, +44 (0)1686 252101; Wales.REC2@wales.nhs.uk), REC ref: 22/WA/0010 |
| Health condition(s) or problem(s) studied | Carers of people living with dementia; some of whom will be experiencing anxiety and/or depression |
| Intervention | The two arms will be the Empowered Conversations training intervention (plus Treatment as Usual), or Treatment as Usual (TAU) waitlist control. Empowered Conversations is a six-session online course and a psychosocial intervention. Randomisation will be performed as block randomisation with a 2:1 allocation, in favour of the immediate intervention arm. Carer self-report measures will be analysed at baseline and 6-month follow up in order to estimate the SD of outcome measures and examine recruitment and retention. Cost-effectiveness feasibility data will also be collected as part of this work package. Those in the TAU arm will receive EC at the end of their follow-up, assuming they still wish to receive it. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Recruitment numbers achieved per month, i.e. per month an average of 6-10 carers |
| Key secondary outcome measure(s) |
The candidate primary outcome measures (all measured at 6 months) are: |
| Completion date | 31/08/2023 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 75 |
| Key inclusion criteria | 1. Carer participants will be included if they live within the Greater Manchester area and are informally caring for someone living with dementia 2. Able to give informed consent 3. Have sufficient English language skills to understand the training (i.e. verbal and written language abilities required to understand verbal presentations and complete simple exercises) 4. Carer ability to participate will not be conditional on carers’ agreement to approach the person living with dementia or being able to consent the person living with dementia to be interviewed |
| Key exclusion criteria | Unable to give informed consent to the trial |
| Date of first enrolment | 07/03/2022 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Ashton-under-lyne
OL6 7SR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | Fully anonymised data will be deposited in a public repository (Figshare), which is a publicly available and searchable platform where it will be permanently stored. Researchers at other institutions and others can access the anonymised data directly from the repository and use it for further research or to check the analysis and results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 10/07/2023 | 26/10/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Participant experiences | 09/10/2024 | 10/10/2024 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/10/2024: Publication reference added.
26/10/2023: Publication reference added.
28/02/2022: Trial's existence confirmed by the Welsh Research Ethics Committee 2.
