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

December 7, 2023 updated by: Centre Hospitalier Universitaire Dijon

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Users
Person with a long-term mental disorder
Other: Questionnaires (Phase 3)
  • CardioVascular Risk (CVR) questionnaire representation
  • SF12
  • Getting Better My Way
  • My recovery plan
  • Psycom
  • Partner In Health scale
Other: 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: 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
Caregivers
Adult helping a person with a long-term psychological disorder
Other: 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: 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
Primary care professionals
Primary care professional in practice following at least one person with a long-term mental disorder
Other: 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: 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
Psychiatric professionals
Psychiatric specialist working in a hospital or in private practice
Other: 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Focus group interview completion
Time Frame: Through study completion, an average of 14 months
Through study completion, an average of 14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DENIS PREPS 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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