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Completed

NCT Number: NCT03689296

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Focus group interview completion

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: COPsyCAT

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2018
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.