Care for depression in people with diabetes and/or coronary heart disease
| ISRCTN | ISRCTN80309252 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80309252 |
| Secondary identifying numbers | 11201 |
- Submission date
- 25/01/2012
- Registration date
- 25/01/2012
- Last edited
- 18/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study aims to evaluate the effectiveness and cost-effectiveness of collaborative care in treating the symptoms of depression in patients who have coronary heart disease (CHD) and/or diabetes. Collaborative care is a method of care management in which the patient, medical doctors and other specialists collaborate to design and deliver a structured care programme for the patient. In the USA there is a lot of evidence suggesting that collaborative care may be beneficial to patients with depression as well as CHD and/or diabetes.
Who can participate?
The study is open to patients aged 18 and over in the North West of the UK who have a diagnosis of CHD and/or diabetes as well as depressive symptoms.
What does the study involve?
General practice surgeries that enter the study are randomly allocated to provide either collaborative care or usual care for patients who are participating in the study.
What are the possible benefits and risks of participating?
Participants will have the chance to receive collaborative care, which has been shown to reduce symptoms of depression for CHD and/or diabetes patients in the USA. We do not anticipate any side effects, risks or disadvantages for people who participate in this study.
Where is the study run from?
The study is being run by the Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at the University of Manchester (UK).
When is the study starting and how long is it expected to run for?
January 2012 to January 2013.
Who is funding the study?
National Institute of Health Research (UK).
Who is the main contact?
Andrea Cherrington
Andrea.Cherrington@manchester.ac.uk
Contact information
Scientific
Community Based Medicine
The University of Manchester
Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 306 7043 |
|---|---|
| Andrea.Cherrington@manchester.ac.uk |
Study information
| Study design | Randomised interventional treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | COllaborative INterventions for CIrculation and DEpression (COINCIDE): Care for depression in people with diabetes and/or coronary heart disease |
| Study acronym | COINCIDE |
| Study objectives | Depression is a prevalent issue for patients suffering from long term conditions (LTC) such as diabetes or coronary heart disease. Patients who experience depression alongside a LTC may find it more difficult to manage their illness properly and experience a poorer standard of health. Effective treatments for depression are available but are under-prescribed for patients with LTCs as depression is frequently undetected and may be viewed by both patients and health professionals as a normal consequence of ill health. The COINCIDE trial will test the effectiveness of collaborative care in the UK for patients with depression and a long-term condition. More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11201 |
| Ethics approval(s) | Preston MRES North West, 28/10/2011 ref: 11/NW/0742 |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | The trial is being run by the University of Manchester and will recruit 450 patients from 30 general practices in the North West of the UK. Patients will be recruited who have signs of depression as well as depression and/or diabetes. General practices will be randomised to give their patients collaborative care or usual care. We will measure levels of depression at study entry and at six month follow-up to evaluate if patients receiving collaborative care have lower levels of depression, compared to those that received usual care. The trial will also evaluate the extent to which patients have utilised health care services and examine the cost-effectiveness of collaborative care. Followed up at 6 months. |
| Intervention type | Other |
| Primary outcome measure | SCL90 depression scale measured at 6 months |
| Secondary outcome measures | Patient Health Questionnaire (PHQ-9) measured at 6 months |
| Overall study start date | 01/01/2012 |
| Completion date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 450 |
| Key inclusion criteria | 1. Patients aged 18 or over 2. Are listed on GP practice QOF registers with a diagnosis of coronary heart disease and/or Type 1 or Type 2 diabetes 3. Have persistent depressive symptoms (>10 on Patient Health Questionnaire PHQ9). 4. Patients who are already receiving antidepressant medication or psychotherapy but who still score >10 on the PHQ9. 5. We will also include non-English speaking patients of South Asian origin 6. Male and female participants |
| Key exclusion criteria | 1. Aged less than 18 years old 2. Refused to consent 3. GP has removed them from the diabetes/CHD database 4. Suffer from a severe and enduring mental disorder 5. At risk of suicide and require immediate care from a crisis management team 6. If their depression is linked to bereavement |
| Date of first enrolment | 01/03/2012 |
| Date of final enrolment | 01/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M13 9PL
United Kingdom
Sponsor information
University/education
c/o Lynne Macrae
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)161 306 6000 |
|---|---|
| Lynne.k.macrae@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/08/2012 | Yes | No | |
| Protocol article | protocol update | 11/05/2013 | Yes | No | |
| Results article | results | 16/02/2015 | Yes | No | |
| Results article | results | 07/10/2016 | Yes | No |
Editorial Notes
18/11/2016: Publication reference added.
