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CompletedNCT03689296COPsyCATUpdated Feb 5, 2026

Patient-caregiver Collaboration for Better Cardiovascular Care for Patients With Long-term Mental Disorders: Multicentre Qualitative and Feasibility Studies

An observational study in Long-term Mental Disorders, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
127
Ages
18 Years and older
Sex
All
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Study 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. 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).

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Conditions studied

  • Long-term Mental Disorders
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In context

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients followed in ambulatory or full hospitalization (depending study phase)

Inclusion criteria

  1. 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,
  2. For the "Users" group:

    - Person with a long-term psychological disorder: Long-term illness (ALD 23), followed by outpatient or full hospitalization

  3. 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,

  4. 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),

  5. For the "Psychiatric Professionals" group - Professional currently in practice who is part of a psychiatry team or in private practice

Exclusion criteria

Exclusion Criteria:

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
127 participants (actual)
Patient registry
No

Groups and cohorts

  • Users

    Person with a long-term mental disorder

    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

    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

    Other: Focus groups (Phase 2) · Other: semi-structured interviews (Phase 1)

  • Psychiatric professionals

    Psychiatric specialist working in a hospital or in private practice

    Other: Focus groups (Phase 2) · Other: semi-structured interviews (Phase 1)

Interventions

  • OtherQuestionnaires (Phase 3)

    * CardioVascular Risk (CVR) questionnaire representation * SF12 * Getting Better My Way * My recovery plan * Psycom * Partner In Health scale

  • OtherFocus groups (Phase 2)

    Focus group interviews conducted by two health sociologists in 4 distinct categories: caregivers, patients, primary health care professionals and psychiatric professionals.

  • Othersemi-structured interviews (Phase 1)

    Conduct of exploratory semi-directive interviews with users, caregivers, primary health care professionals and psychiatric professionals by a health sociologist

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What researchers measure

Primary outcomes

  1. Focus group interview completion

    Time frame: Through study completion, an average of 14 months

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Study locations

1 site
  • Chu Dijon Bourogne
    Dijon, 21000, France
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03689296
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Sep 28, 2018
Start date
Jun 27, 2019
Primary completion
Aug 7, 2024
Completion
Aug 7, 2024
Last update
Feb 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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