CareCoach Feasibility trial – part of the CareCoach programme: adapting and testing an intervention for carers of people with dementia
| ISRCTN | ISRCTN12540555 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12540555 |
| IRAS number | 316710 |
| Secondary identifying numbers | IRAS316710 |
- Submission date
- 12/08/2022
- Registration date
- 18/11/2022
- Last edited
- 21/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Family and informal carers are the main source of support and care for people with dementia. Such carers need to have information and skills to manage and support the day-to-day care they give to the person with dementia. Attention to the carer’s own wellbeing can have positive benefits to the carer and the person with dementia. We have taken a promising online intervention developed in the Netherlands, called ‘Partner in Balance’ (PiB), and adapted this to the UK setting to produce the ‘CareCoach intervention’ package. This is a package of online resources and tips to help carers with the support of a coach to help guide and support carers. The aim of this study is to run a small study of the CareCoach intervention to see if a larger randomised controlled trial is feasible. The main objectives are to test the procedures to identify and recruit carers of people with dementia, test the procedures for collecting outcome data and to see how well we can deliver the CareCoach intervention.
Who can participate?
Participants will be adults (18 years or over) who are currently caring for a person with dementia (all subtypes, diagnosed within the last 5 years). They may be a family member or close friend of the person with dementia. They need to have a spoken understanding of English (with the help of family translators if required). As this is an online intervention, they must have access to internet via a computer, laptop, tablet, iPad or mobile phone with internet capability. If the person with dementia currently lives in a care home, then this intervention would not be suitable for them.
We aim to recruit 42 carers from 7 sites across England and Wales.
What does the study involve?
We will compare the CareCoach intervention with current care as usual (control group). After consenting to the study, approximately half the Carer participants will be randomly assigned to the CareCoach intervention or and the other half will continue usual care. Those in the CareCoach intervention group will be given a personal login and have access to the CareCoach online resources and a coach for 8 weeks who will encourage the participant to work through several of the CareCoach modules. After 8 weeks, CareCoach participants may continue to have access to the online resources but not the coach. At 6 months, we will ask all participants a series of questions about their health, wellbeing, use of health resources and the person with dementia’s health and wellbeing.
A small number of participants will be asked to take part in an interview study to find out their views and experiences of being part of this study.
What are the possible benefits and risks of participating
The possible benefits of taking part are that some participants may enjoy taking part in research and may find some benefit of the intervention or talking about their situation. The risks are that it may take up some of their time and could raise sensitive issues or anxieties around the person with dementia that they care for.
Where is the study run from?
The study is run from the Norwich Clinical Trials Unit, based at the University of East Anglia, UK. The University of Exeter is sponsoring the whole programme of research.
When is the study starting and how long is it expected to run for?
August 2021 to December 2024
Who is funding the study?
The study is funded as part of the programme grant from the National Institute for Health and Care Research, UK. (PGfAR NIHR201076)
Who is the main contact?
1. Dr Helen Morse, carecoach@uea.ac.uk
2. Prof. Chris Fox, christopher.fox@exeter.ac.uk
Contact information
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 |
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 |
Study information
| Study design | Mixed methods multicentre randomized controlled trial feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | CareCoachWP3 - A feasibility trial to assess the design and deliverability of a multi-centre randomised controlled trial of the CareCoach package, part of the CareCoach programme: adapting and testing an intervention for carers of people with dementia |
| Study acronym | CareCoachWP3 |
| Study objectives | It is feasible to run a full scale randomised controlled trial to test the effectiveness of the CareCoach intervention package? |
| Ethics approval(s) |
Approved 08/11/2022, North West Greater Manchester East Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 2071048199; gmeast.rec@hra.nhs.uk), ref: 22/NW/0293 |
| Health condition(s) or problem(s) studied | The well-being of carers of people with dementia |
| Intervention | Participants will be randomised by a computer generated randomisation scheme on an individual participant level (1:1) stratified by site. They will be allocated to the CareCoach intervention group or control arm. CareCoach intervention – This group will be given access to an online self-management CareCoach programme comprising an 8 week course of up to 9 modules with 1-to-1 support from a coach. The coach will arrange at least two meetings with them (at the start and end of the 8 week course) and may be available for additional brief meetings or on the message function of the programme at other times. After 8 weeks, the participants will continue to have access to the online materials, but not to the coach. The usual care/control group – This will be care as usual as per NICE guidance. This may include carer support groups or information leaflets provided by the Trust or other organisations. Both groups will be asked to complete follow up questionnaires (paper or online) at 6 months post randomisation. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. The recruitment rate will be recorded as the number of eligible participants who consented to participate in the study over the 6 month recruitment period. 2. The attrition rate will be recorded as the number of eligible participants who consented to participate in the study but had not completed the final 6 month follow-up measures. |
| Secondary outcome measures | Measured at baseline and 6 months: 1. The Caregiver Self-Efficacy Scale (CSES) 2. The Pearlin Mastery Scale (PMS) 3. The Perceived Stress Scale (PSS) 4. The Centre for Epidemiological Studies Depression scale (CES-D) 5. The Generalised Anxiety Disorder 7-item scale (GAD-7) 6. Scale measuring the Impact of DEmentia on CARers (SIDECAR-D) 7. Modified Client Service Receipt Inventory (CSRI) 8. EuroQol Health Related Quality of Life (EQ-5D-5L) 9. Patient Health Questionnaire (PHQ-9). 10. The Goal Attainment Scaling (GAS, intervention only) Carer proxy rating of the person with Dementia: 11. Neuropsychiatric Inventory (NPI-Q) 12. Proxy EuroQol Health Related Quality of Life (EQ-5D-5L) 13. A small subset of participants will be interviewed and qualitative data will assess whether the intervention is perceived as acceptable to participants. |
| Overall study start date | 01/08/2021 |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 42 |
| Total final enrolment | 42 |
| Key inclusion criteria | 1. Aged 18 years old or above 2. Spoken understanding of the English language (with the help of family translators if required) 3. Currently caring for a person with dementia (all subtypes, diagnosed within the last 5 years) 4. Has a first-degree relationship (spouse/partner, sibling, son or daughter) with a person with dementia; OR must have a close personal relationship with a person with dementia (e.g. in-law family member, close friend or neighbour) 5. Has capacity to give informed consent to participate; 6. Has access to the internet (via a home computer/laptop, iPad/tablet or mobile phone with internet capability) |
| Key exclusion criteria | 1. Potential participants with insufficient cognitive abilities to engage in the online programme 2. Overburdened, as determined by study staff. 3. If the person with dementia they care for currently resides in a care home |
| Date of first enrolment | 19/06/2023 |
| Date of final enrolment | 19/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Drayton High Road
Norwich
NR6 5BE
United Kingdom
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
Dryden Road
Exeter
EX2 5AF
United Kingdom
Highpoint Venue
Bursledon Road
Southampton
SO19 8BR
United Kingdom
Nottingham
NG6 9DR
United Kingdom
Heights Lane
Bradford
BD9 6DP
United Kingdom
Royal United Hospital
Combe Park
Bath
BA1 3NG
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 | http://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 | 30/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Given that this is a feasibility study, the results of this trial will inform the study processes and outcome measures of a definitive RCT (CareCoachWP4). The results of the wider programme will be disseminated regardless of the direction of effect. We will inform professionals through academic and professional journals, conferences, events, and social media. Participants taking part in the study may be sent a newsletter and can be kept informed about the study by accessing our study website and social media. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Statistical Analysis Plan | version 1.0 | 11/05/2024 | 15/05/2024 | No | No |
| Results article | 22/05/2024 | 23/05/2024 | Yes | No | |
| Statistical Analysis Plan | version 2.0 | 07/11/2024 | 21/11/2024 | No | No |
Additional files
Editorial Notes
21/11/2024: Statistical analysis plan added.
23/05/2024: Publication reference added.
15/05/2024: Statistical analysis plan added.
04/12/2023: The following changes were made to the study record:
1. The recruitment start date was changed from 01/03/2023 to 19/06/2023.
2. The recruitment end date was changed from 30/12/2023 to 19/10/2023.
3. The overall study end date was changed from 30/12/2024 to 31/05/2024.
4. Total final enrolment added.
5. Contact and sponsor details added.
6. Nottinghamshire Healthcare NHS Foundation Trust, Bradford District Care Foundation Trust and RICE - The Research Institute for the Care of Older People were added as study participating centres.
10/01/2023: Ethics approval details added. The recruitment start date was changed from 03/01/2023 to 01/03/2023.
16/08/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
