The DECIDE study: dementia carers making informed decisions
ISRCTN | ISRCTN58368696 |
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DOI | https://doi.org/10.1186/ISRCTN58368696 |
Secondary identifying numbers | N/A |
- Submission date
- 03/05/2016
- Registration date
- 14/06/2016
- Last edited
- 10/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Dementia is a common condition caused by the ongoing decline of the brain and its abilities with age. People with dementia and their relatives find it difficult to make decisions about whether they should live in a care home.The aim of this study is to develop and test a decision aid, known as the 'DECIDE manual', for carers of people with dementia to use when making decisions about living arrangements and place of care for their relative.
Who can participate?
Family/friend carers of people with dementia
What does the study involve?
Participants are randomly allocated to one of two groups. One group receives the 'usual treatment', in this case being given a copy of the Alzheimer’s Society factsheet 'Selecting a care home'. The other group receives the DECIDE manual, which the researcher takes participants through at the initial interview. All participants answer questions about decision-making and how they care currently feeling at the initial assessment, and 1 week and 10 weeks later.
What are the possible benefits and risks of participating?
We cannot promise the study will help participants but the information we get might help improve the support offered to carers of people with dementia and help healthcare staff discuss living arrangements and place of care with families in the future. We do not anticipate that there will be any disadvantages to taking part except for the inconvenience of making time for the interview, but it is possible that some topics discussed concerning the stresses of caring may be upsetting, so participants will be given details of appropriate, independent support services.
Where is the study run from?
This project is based at University College London and participants will be recruited from four memory clinics across three London boroughs: Camden Memory Service and Islington Memory Assessment and Treatment Service within Camden and Islington NHS Foundation trust; Haringey Memory Service within Barnet, Enfield and Haringey Mental Health trust and Tower Hamlets Diagnostic Memory Clinic within East London NHS Foundation trust.
When is the study starting and how long is it expected to run for?
August 2014 to April 2016
Who is funding the study?
UCL IMPACT studentship and the Division of Psychiatry (UK)
Who is the main contact?
Kathryn Lord
Contact information
Public
Division of Psychiatry
University College London (UCL)
6th Floor, Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
0000-0001-6681-2624 |
Study information
Study design | 10-week pre and post design |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Community |
Study type | Other |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | The DECIDE study: dementia carers making informed decisions |
Study objectives | Family carers who receive the DECIDE manual intervention will find the resource relevant and useful and to evaluate trial recruitment and retention in preparation for a full, pragmatic trial of the intervention. |
Ethics approval(s) | 1. National Research Ethics Service Committee North East – Newcastle & North Tyneside 2, January 2015; REC Reference: 15/NE/0015 2. Local approval was obtained from all regions where the study was conducted (East London and Camden and Islington NHS Foundation Trusts and Barnet, Enfield and Haringey Mental Health NHS Trust) |
Health condition(s) or problem(s) studied | Carers of people with dementia |
Intervention | Half of the cohort will receive the DECIDE decision aid we have created, the other half will receive 'treatment as usual'. In this instance that will be telling carers that if they want any further information they should speak with their healthcare professional. |
Intervention type | Behavioural |
Primary outcome measure | The proportion of family carers who receive the DECIDE manual who report finding it relevant (defined a priori as a score of 4 or 5 on a 5 point Likert scale) and the proportion of family carers who receive the DECIDE manual who report finding it useful (defined a priori as a score of 8, 9 or 10 on a 10 point Likert scale). |
Secondary outcome measures | To test the secondary hypothesis that family carers who receive the DECIDE manual intervention will report lower scores on the total Decisional Conflict Scale score and Informed sub-scale score, when compared to family carers in the treatment as usual group 10 weeks post baseline. |
Overall study start date | 07/08/2014 |
Completion date | 01/04/2016 |
Eligibility
Participant type(s) | Carer |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 40 |
Total final enrolment | 41 |
Key inclusion criteria | 1. Current, unpaid, main informal carer (e.g. a family member or friend in regular contact who is either next of kin or a ‘key decision maker’) 2. English language skills sufficient to participate in interviews. Whilst it is acknowledged that that the ideal would be to use the first language of all potential participants unfortunately there were not funds to provide interpreters |
Key exclusion criteria | 1. Carers under the age of 18 years 2. Carers where there are clinical concerns that may preclude them from being approached such as severe physical or mental illness or lack of capacity to give informed consent |
Date of first enrolment | 01/05/2015 |
Date of final enrolment | 01/01/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
University/education
Joint Research Office
Gower Street
London
WC1E 6BT
England
United Kingdom
https://ror.org/02jx3x895 |
Funders
Funder type
University/education
No information available
Results and Publications
Intention to publish date | 31/12/2016 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | We intend to publish the results of the feasibility trial this summer/before the end of the year. |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
HRA research summary | 28/06/2023 | No | No | ||
Results article | 02/02/2017 | 10/07/2023 | Yes | No |
Editorial Notes
10/07/2023: Publication reference and total final enrolment added.
24/05/2019: Internal review.