Condition category
Mental and Behavioural Disorders
Date applied
25/01/2012
Date assigned
25/01/2012
Last edited
18/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

http://www.coincidehealth.co.uk

Contact information

Type

Scientific

Primary contact

Dr Andrea Cherrington

ORCID ID

Contact details

Community Based Medicine
The University of Manchester
Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 7043
Andrea.Cherrington@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11201

Study information

Scientific title

COllaborative INterventions for CIrculation and DEpression (COINCIDE): Care for depression in people with diabetes and/or coronary heart disease

Acronym

COINCIDE

Study hypothesis

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

Preston MRES North West, 28/10/2011 ref: 11/NW/0742

Study design

Randomised interventional treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

SCL90 depression scale measured at 6 months

Secondary outcome measures

Patient Health Questionnaire (PHQ-9) measured at 6 months

Overall trial start date

01/01/2012

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 450

Participant 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

Recruitment start date

01/03/2012

Recruitment end date

01/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Lynne Macrae
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 6000
Lynne.k.macrae@manchester.ac.uk

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) - CLAHRC (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22906179
2013 protocol update in: http://www.ncbi.nlm.nih.gov/pubmed/23663556
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25687344
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27855101

Publication citations

  1. Protocol

    Coventry PA, Lovell K, Dickens C, Bower P, Chew-Graham C, Cherrington A, Garrett C, Gibbons CJ, Baguley C, Roughley K, Adeyemi I, Keyworth C, Waheed W, Hann M, Davies L, Jeeva F, Roberts C, Knowles S, Gask L, Collaborative Interventions for Circulation and Depression (COINCIDE): study protocol for a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease., Trials, 2012, 13, 139, doi: 10.1186/1745-6215-13-139.

  2. Protocol update

    Coventry PA, Lovell K, Dickens C, Bower P, Chew-Graham C, Cherrington A, Garrett C, Gibbons CJ, Baguley C, Roughley K, Adeyemi I, Keyworth C, Waheed W, Hann M, Davies L, Jeeva F, Roberts C, Knowles S, Gask L, Update on the collaborative interventions for circulation and depression (COINCIDE) trial: changes to planned methodology of a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease., Trials, 2013, 14, 136, doi: 10.1186/1745-6215-14-136.

  3. Results

    Coventry P, Lovell K, Dickens C, Bower P, Chew-Graham C, McElvenny D, Hann M, Cherrington A, Garrett C, Gibbons CJ, Baguley C, Roughley K, Adeyemi I, Reeves D, Waheed W, Gask L, Integrated primary care for patients with mental and physical multimorbidity: cluster randomised controlled trial of collaborative care for patients with depression comorbid with diabetes or cardiovascular disease, BMJ, 2015, 350, h638, doi: 10.1136/bmj.h638.

Additional files

Editorial Notes

18/11/2016: Publication reference added.