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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689296
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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
Long-term Mental Disorders Other: Questionnaires

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Study Type : Observational
Estimated Enrollment : 120 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 : June 27, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Users
Person with a long-term mental disorder
Other: Questionnaires
  • CardioVascular Risk (CVR) questionnaire representation
  • SF12
  • Citizenship Measurement (CM) Scale
  • Recovery Assessment Scale
  • Score Ricci-Gagnon

Caregivers
Adult helping a person with a long-term psychological disorder
Other: Questionnaires
  • CardioVascular Risk (CVR) questionnaire representation
  • SF12
  • Citizenship Measurement (CM) Scale
  • Recovery Assessment Scale
  • Score Ricci-Gagnon

Primary care professionals
Primary care professional in practice following at least one person with a long-term mental disorder
Other: Questionnaires
  • CardioVascular Risk (CVR) questionnaire representation
  • SF12
  • Citizenship Measurement (CM) Scale
  • Recovery Assessment Scale
  • Score Ricci-Gagnon

Psychiatric professionals
Psychiatric specialist working in a hospital or in private practice
Other: Questionnaires
  • CardioVascular Risk (CVR) questionnaire representation
  • SF12
  • Citizenship Measurement (CM) Scale
  • Recovery Assessment Scale
  • Score Ricci-Gagnon




Primary Outcome Measures :
  1. Focus group interview completion [ Time Frame: Through study completion, an average of 14 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed in ambulatory or full hospitalization
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689296


Contacts
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Contact: Frédéric DENIS +33 3 80 42 56 59 frederic.denis@chlcdijon.fr

Locations
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France
Chu Dijon Bourogne Recruiting
Dijon, France, 21000
Contact: Frédéric DENIS    +33 3 80 42 56 59    frederic.denis@chlcdijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03689296    
Other Study ID Numbers: DENIS PREPS 2017
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders