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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03689296
Other study ID # DENIS PREPS 2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 27, 2019
Est. completion date June 2025

Study information

Verified date May 2024
Source Centre Hospitalier Universitaire Dijon
Contact Frédéric DENIS
Phone +33 3 80 42 56 59
Email frederic.denis@chlcdijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 157
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Questionnaires (Phase 3)
CardioVascular Risk (CVR) questionnaire representation SF12 Getting Better My Way My recovery plan Psycom Partner In Health scale
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.
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

Locations

Country Name City State
France Chu Dijon Bourogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Focus group interview completion Through study completion, an average of 14 months