CareCoach Study: Testing the clinical and cost-effectiveness of an online support package (CareCoach) for family carers of people living with dementia
| ISRCTN | ISRCTN15462720 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15462720 |
| IRAS number | 338454 |
| Secondary identifying numbers | PGfAR NIHR201076, CPMS 61261 |
- Submission date
- 18/11/2024
- Registration date
- 27/01/2025
- Last edited
- 17/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
People who care for those living with dementia (carers or caregivers) need information and skills to manage daily care. This study aims to test the effects of an online support package called CareCoach. We want to see if CareCoach improves carers' ability to care, their mood, and quality of life. This study is part of the larger CareCoach Research Programme and follows a successful pilot study. We aim to recruit 404 family carers for this trial.
Who can participate?
Family carers of people living with dementia who are 18 years or older, living in the UK, and have access to a device with a camera and microphone connected to the internet.
What does the study involve?
Participants will be randomly assigned to either the CareCoach group or a control group that receives usual care. Those in the CareCoach group will use the online platform and receive support from a coach for 8 weeks. All participants will complete questionnaires online or by post at the start, 10 weeks, and 6 months into the study. Recruitment will be through various channels including social media, community groups, and charities. There will also be group discussions and interviews to explore experiences with CareCoach.
What are the possible benefits and risks of participating?
Participants may benefit from improved caregiving skills, mood, and quality of life. There are minimal risks, but some may find the questionnaires or discussions time-consuming or emotionally challenging.
Where is the study run from?
The study is run from the University of Exeter (UK).
When is the study starting and how long is it expected to run for?
December 2023 to January 2027.
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
carecoach@uea.ac.uk
Christopher.Fox@exeter.ac.uk
j.cross@uea.ac.uk
Contact information
Public
Norwich Clinical Trials Unit
Norwich Medical School
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
| Phone | +44 1603 591120 |
|---|---|
| carecoach@uea.ac.uk |
Principal Investigator
College of Medicine & Health
St Luke’s Campus
Heavitree Road
Exeter
EX1 2HZ
United Kingdom
 ORCID ID |
0000-0001-9480-5704 |
|---|---|
| Phone | +44 7411 746549 |
| Christopher.Fox@exeter.ac.uk |
Scientific
School of Health Sciences
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
| ORCID ID |
0000-0002-7003-1916 |
|---|---|
| Phone | +44 1603593315 |
| j.cross@uea.ac.uk |
Study information
| Study design | Multicentre mixed-methods two-armed parallel group (intervention vs control) randomized controlled trial with health economic evaluation and embedded qualitative sub-study (implementation and carer experience evaluation) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Home, Internet/virtual |
| Study type | Quality of life, Efficacy |
| Participant information sheet | Available when recruitment opens at https://carecoachtimes.org/take-part/ |
| Scientific title | CareCoach Study: Testing the clinical and cost-effectiveness of CareCoach for family carers of people living with dementia. |
| Study objectives | Testing the clinical and cost-effectiveness of using a blended care (e-health, one-to-one coaching) intervention (CareCoach) for family carers of people living with dementia compared to usual care. |
| Ethics approval(s) |
Approved 27/12/2024, North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 207 104 8077; gmeast.rec@hra.nhs.uk), ref: 24/NW/0376 |
| Health condition(s) or problem(s) studied | Family carers/caregivers of people living with dementia |
| Intervention | Randomisation to treatment arm will take place after consent and baseline data have been collected. The randomisation scheme will be computer-generated by the Clinical Trials Unit data manager. This will be an individually randomised trial. Randomisation will be stratified by recruiting site, age (<65 years vs ≥65 years), and relationship to the person living with dementia (e.g. spouse/partner versus all others). Randomisation will be blocked with random block lengths of either 2, 4 or 6. Intervention Arm: In addition to standard care, participants will be allocated a ‘coach’ (health, social care or dementia charity worker) and given a personal login to the CareCoach platform which is an online self-management programme where participants work through up to four learning modules. After an initial meeting with the coach (e.g., via video call), carers will use CareCoach for 8 weeks. They can consult with the coach throughout this period for guidance via the messaging function within the CareCoach platform. At the end of the 8-week course, the participant has a final review meeting with the coach. Control (Usual Care): Standard care provided by NHS and non-NHS organisations as per NICE guidance including advice from dementia services (e.g. memory clinics) and carer support (e.g. groups, leaflets from NHS Trust, Dementia UK, Alzheimer’s Society, signpost to local authority carer forums, and carer counselling). Participants in the control group will be offered access to the CareCoach online resources for 6 months following the end of the study. |
| Intervention type | Behavioural |
| Primary outcome measure | Carer self-efficacy symptom management in the Caregiver Self-Efficacy Scale (CSES) at 6 months post-randomisation |
| Secondary outcome measures | Clinical outcomes (carers only): 1. Self-efficacy for symptom management is measured using CSES at 10 weeks post-randomisation 2. Self-efficacy for community support service use is measured using CSES at baseline, 10 weeks post-randomisation, and 6 months post-randomisation 3. Mastery is measured using the Pearlin Mastery Scale (PMS) at baseline, 10 weeks post-randomisation, and 6 months post-randomisation 4. Impact of dementia on carers is measured using SIDECAR-D at baseline, 10 weeks post-randomisation, and 6 months post-randomisation 5. Perceived stress is measured using the Perceived Stress Scale (PSS) at baseline, 10 weeks post-randomisation, and 6 months post-randomisation 6. Anxiety is measured using the Generalised Anxiety Disorder Scale (GAD-7) at baseline, 10 weeks post-randomisation, and 6 months post-randomisation 7. Depression is measured using the Patient Health Questionnaire (PHQ-9) at baseline, 10 weeks post-randomisation, and 6 months post-randomisation 8. Health-related quality of life is measured using EQ-5D-5L at baseline, 10 weeks post-randomisation, and 6 months post-randomisation Cost-effectiveness outcomes: 9. Carer-rated proxy health-related quality of life of the person living with dementia is measured using EQ-5D-5L at baseline, 10 weeks post-randomisation, and 6 months post-randomisation 10. Service use is measured using the Modified Client Service Receipt Inventory (CSRI) at baseline and 6 months post-randomisation |
| Overall study start date | 01/12/2023 |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 404 |
| Key inclusion criteria | 1. Currently care/support (e.g., informally, unpaid*) for a person living with dementia (may be a partner, family member, in-law, close friend or neighbour) 2. The person living with dementia (all subtypes) has been diagnosed within the last 5 years 3. 18 years or over 4. Living in the UK 5. Access to a device with a camera and microphone which connects to the internet (e.g., laptop, tablet, smartphone) 6. Seeking to learn new skills and knowledge to cope well while caring for a person living with dementia 7. Able to engage in and understand the programme delivered in English (with the help of a family interpreter if required) *Family carers claiming carer’s allowance are not excluded |
| Key exclusion criteria | 1. Potential participants with insufficient cognitive abilities to engage with the online programme 2. Potential participants who report feeling overburdened 3. The person living with dementia currently resides in a care home 4. Taking part or recently taken part in a research study using a similar behaviour change or psychological intervention 5. Taken part in CareCoach (Work Package 3) feasibility study (ISRCTN12540555) 6. Is a paid, professional carer Multiple members of the same family (e.g., individuals caring for the same person living with dementia) should not sign up for the trial to avoid potential contamination between groups |
| Date of first enrolment | 31/01/2025 |
| Date of final enrolment | 07/04/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Earlham Road
Norwich
NR4 7TJ
United Kingdom
Sponsor information
University/education
Research Ethics and Governance Office
Lafrowda House
St German’s Road
Exeter
EX4 6TL
England
United Kingdom
| Phone | +44 1392 723588 |
|---|---|
| res-sponsor@exeter.ac.uk | |
| Website | https://www.exeter.ac.uk/ |
"ROR" |
https://ror.org/03yghzc09 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of the trial will be disseminated regardless of the direction of effect. Outputs from the trial will be available on the trial website and social media for public access and in programme newsletters. The results of this trial (and wider programme) will be also be disseminated in peer reviewed scientific journals, funder report, and conference presentations. The Arising Intellectual Property in the research data and results of analysis of such shall be owned by UEA. The publication policy is in line with rules of the International Committee of Medical Journal Editors . |
| IPD sharing plan | A formal data-sharing plan for this trial is not yet available. Requests for access to trial data will be considered, and approved in writing where appropriate, after formal application to the Programme Management Group and/or Programme Steering Committee. |
Editorial Notes
17/04/2025: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment end date was changed from 31/01/2026 to 07/04/2026.
18/11/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
