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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Recruiting
CT.gov ID
NCT03689296
Collaborator
(none)
157
1
53.2
3

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaires (Phase 3)
  • Other: Focus groups (Phase 2)
  • Other: semi-structured interviews (Phase 1)

Study Design

Study Type:
Observational
Anticipated Enrollment :
157 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Patient-caregiver Collaboration for Better Cardiovascular Care for Patients With Long-term Mental Disorders: Multicentre Qualitative and Feasibility Studies
Actual Study Start Date :
Jun 27, 2019
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Focus group interview completion [Through study completion, an average of 14 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

  1. For the "Users" group:
  • Person with a long-term psychological disorder: Long-term illness (ALD 23), followed by outpatient or full hospitalization
  1. 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,
  1. 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),
  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT03689296
Other Study ID Numbers:
  • DENIS PREPS 2017
First Posted:
Sep 28, 2018
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022