Long-term Mental DisordersCOPsyCATNCT03689296
Patient-caregiver Collaboration for Better Cardiovascular Care for Patients With Long-term Mental Disorders: Multicentre Qualitative and Feasibility Studies
An observational study of Long-term Mental Disorders, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
People with severe and persistent mental disorders (or SMI, Severe Mental Illness) have a life expectancy which is 20 years less than the general population, mainly due to excess mortality related to cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long-term Mental Disorders
- What is being tested?
- Questionnaires (Phase 3), Focus groups (Phase 2) and semi-structured interviews (Phase 1)
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2019to 7 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed in ambulatory or full hospitalization (depending study phase)
Who may be able to join
- For all groups:
- Adult person,
- Person who has given his or her consent to participate in the study, with the consent of the tutor in the context of guardianship,
- Fluent use of the French language,
- For the "Users" group:
- Person with a long-term psychological disorder: Long-term illness (ALD 23), followed by outpatient or full hospitalization
Show all 11Show fewer
- For the "Caregivers" group:
- Adult helping a person with a long-term psychological disorder with a Long-Term Disability (ALD 23) and who has given his or her consent to be contacted for the study,
- For the "Primary Care Professionals" group:
- Primary care professional in practice following at least one person with a long-term psychological disorder with a Long-Term Disability (ALD 23),
- For the "Psychiatric Professionals" group - Professional currently in practice who is part of a psychiatry team or in private practice
Who cannot join
- 1. For all groups:
- Person who is physically or psychologically unable to participate in the focus group and/or program at the time of the study
- Person not affiliated to the National Health Insurance
- Objection to participation by the patient or his legal representative, carers and health professionals.
- Patient under guardianship
- Patient who participated in Phase 1 or 2 of the study
- Patient not able to attend the 6-month visit
Trial locations and contacts
1 site in 1 country.
About this study
People with severe and persistent mental disorders (or SMI, Severe Mental Illness) have a life expectancy which is 20 years less than the general population, mainly due to excess mortality related to cardiovascular disease. Moreover, despite an overall increase in life expectancy, the gap is widening between people with long-term psychological disorders and the general population.
This early excess mortality is explained by disparities between people with SMI and the general population not only in access to and use of health services but also in the quality and type of care provided. There is also an over-representation of risk factors and cardiovascular pathologies regardless of the mental disorder, despite the current recommendations for best practices.
Read more
The World Health Organization has defined the fight against somatic comorbidities as one of the axes of the European Mental Health Plan and one of the reference themes of the World Health Organization Mental Health Evidence and Research Programme (EPSM-Lille-Métropole). The Groupement de Coopération Sanitaire pour la recherche et la formation en santé mentale, which brings together 17 hospitals in France and relays the actions of the World Health Organization's Collaborating Centre, has decided to make it into a national research project.
Moreover, it is recognized that "medical" management of a disease is all the more effective when the patient is involved. However, the empowerment of people with long-term psychological disorders has never been put at the centre of a strategy to reduce cardiovascular risk.
In this context, we hypothesize that one of the keys to reducing cardiovascular risk would be to take into account the experience and representations of this risk by all stakeholders (people with long-term psychological disorders, their carers, primary health professionals and psychiatric professionals).
- Conditions
- Long-term Mental Disorders
- Being tested
- Questionnaires (Phase 3), Focus groups (Phase 2), semi-structured interviews (Phase 1)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires (Phase 3)Other
- CardioVascular Risk (CVR) questionnaire representation
- SF12
- Getting Better My Way
- My recovery plan
- Psycom
- Partner In Health scale
Focus groups (Phase 2)Other
Focus group interviews conducted by two health sociologists in 4 distinct categories: caregivers, patients, primary health care professionals and psychiatric professionals.
semi-structured interviews (Phase 1)Other
Conduct of exploratory semi-directive interviews with users, caregivers, primary health care professionals and psychiatric professionals by a health sociologist
| Study group | Role | What they receive |
|---|---|---|
| Users | Person with a long-term mental disorder Receives: Other: Questionnaires (Phase 3); Other: Focus groups (Phase 2); Other: semi-structured interviews (Phase 1) | |
| Caregivers | Adult helping a person with a long-term psychological disorder Receives: Other: Focus groups (Phase 2); Other: semi-structured interviews (Phase 1) | |
| Primary care professionals | Primary care professional in practice following at least one person with a long-term mental disorder Receives: Other: Focus groups (Phase 2); Other: semi-structured interviews (Phase 1) | |
| Psychiatric professionals | Psychiatric specialist working in a hospital or in private practice Receives: Other: Focus groups (Phase 2); Other: semi-structured interviews (Phase 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focus group interview completion
Measured: Through study completion, an average of 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start27 Jun 2019
- Primary completion7 Aug 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long-term Mental DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689296
- Sponsor's protocol ID
- DENIS PREPS 2017
- Acronym
- COPsyCAT
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2018
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baleige A, Besnard JF, Meunier-Beillard N, Demassiet V, Monnier A, Ouezini A, Lambert O, Charrel C, Mazas O, Oberlin J, Roelandt JL, Denis F. A collaboration between service users and professionals for the development and evaluation of a new program for cardiovascular risk management in persons with a diagnosis of severe mental illness: French multicenter qualitative and feasibility studies. Int J Ment Health Syst. 2019 Dec 27;13:74. doi: 10.1186/s13033-019-0331-6. eCollection 2019.
PubMed 31889999
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-caregiver Collaboration for Better Cardiovascular Care for Patients With Long-term Mental Disorders: Multicentre Qualitative and Feasibility Studies
- ClinicalTrials.gov ID
- NCT03689296
- Acronym / sponsor ID
- COPsyCAT / DENIS PREPS 2017
- Conditions
- Long-term Mental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with severe and persistent mental disorders (or SMI, Severe Mental Illness) have a life expectancy which is 20 years less than the general population, mainly due to excess mortality related to cardiovascular disease. Moreover, despite an overall increase in life expectancy, the gap is widening between people with long-term psychological disorders and the general population.
This early excess mortality is explained by disparities between people with SMI and the general population not only in access to and use of health services but also in the quality and type of care provided. There is also an over-representation of risk factors and cardiovascular pathologies regardless of the mental disorder, despite the current recommendations for best practices.
The World Health Organization has defined the fight against somatic comorbidities as one of the axes of the European Mental Health Plan and one of the reference themes of the World Health Organization Mental Health Evidence and Research Programme (EPSM-Lille-Métropole). The Groupement de Coopération Sanitaire pour la recherche et la formation en santé mentale, which brings together 17 hospitals in France and relays the actions of the World Health Organization's Collaborating Centre, has decided to make it into a national research project.
Moreover, it is recognized that "medical" management of a disease is all the more effective when the patient is involved. However, the empowerment of people with long-term psychological disorders has never been put at the centre of a strategy to reduce cardiovascular risk.
In this context, we hypothesize that one of the keys to reducing cardiovascular risk would be to take into account the experience and representations of this risk by all stakeholders (people with long-term psychological disorders, their carers, primary health professionals and psychiatric professionals).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Users | – | Other: Questionnaires (Phase 3), Other: Focus groups (Phase 2), Other: semi-structured interviews (Phase 1)Person with a long-term mental disorder |
| Caregivers | – | Other: Focus groups (Phase 2), Other: semi-structured interviews (Phase 1)Adult helping a person with a long-term psychological disorder |
| Primary care professionals | – | Other: Focus groups (Phase 2), Other: semi-structured interviews (Phase 1)Primary care professional in practice following at least one person with a long-term mental disorder |
| Psychiatric professionals | – | Other: Focus groups (Phase 2), Other: semi-structured interviews (Phase 1)Psychiatric specialist working in a hospital or in private practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed in ambulatory or full hospitalization (depending study phase)
Key inclusion criteria (11 listed)
- For all groups:
- For the "Users" group:
- For the "Caregivers" group:
- For the "Primary Care Professionals" group:
- For the "Psychiatric Professionals" group - Professional currently in practice who is part of a psychiatry team or in private practice
Key exclusion criteria (7 listed)
- Person who is physically or psychologically unable to participate in the focus group and/or program at the time of the study
- Person not affiliated to the National Health Insurance
- Objection to participation by the patient or his legal representative, carers and health professionals.
- Patient under guardianship
- Patient who participated in Phase 1 or 2 of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires (Phase 3)* CardioVascular Risk (CVR) questionnaire representation * SF12 * Getting Better My Way * My recovery plan * Psycom * Partner In Health scale | Other | Users |
| Focus groups (Phase 2)Focus group interviews conducted by two health sociologists in 4 distinct categories: caregivers, patients, primary health care professionals and psychiatric professionals. | Other | Caregivers, Primary care professionals, Psychiatric professionals, Users |
| semi-structured interviews (Phase 1)Conduct of exploratory semi-directive interviews with users, caregivers, primary health care professionals and psychiatric professionals by a health sociologist | Other | Caregivers, Primary care professionals, Psychiatric professionals, Users |
Primary outcome
Focus group interview completion
Time frame: Through study completion, an average of 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 31889999Baleige A, Besnard JF, Meunier-Beillard N, Demassiet V, Monnier A, Ouezini A, Lambert O, Charrel C, Mazas O, Oberlin J, Roelandt JL, Denis F. A collaboration between service users and professionals for the development and evaluation of a new program for cardiovascular risk management in persons with a diagnosis of severe mental illness: French multicenter qualitative and feasibility studies. Int J Ment Health Syst. 2019 Dec 27;13:74. doi: 10.1186/s13033-019-0331-6. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-term Mental Disorders, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focus group interview completion (time frame: Through study completion, an average of 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.