- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05737966
Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist (CHECKLISTPEP)
Psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. Current research and recommendations for good practice are moving towards early detection and intervention. It is recognized that this leads to better adherence, alliance to care and knowledge of pathology for the patient, especially in young patients. For more than a decade, early intervention services (EIS) are opened in France over an increasingly large territory. Still too few studies assess the impact of these structures in France. These EIS offer a multimodal intervention (social, professional, psychotherapeutic). The intervention of case managers (or care coordinators in french) seems to be the core of EIS. The case manager has a fundamental role in the process of recovery in coordinating each individual's treatment and ensuring continuity of care.
The PEPsy-CM study aims to evaluate the effectiveness on the relapse rate of a 3 year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in a population of young people with a FEP.
A qualitative evaluation of case management practice in EIS seems essential to assess the impact of case managers under real conditions.
Based on the Australian Good Practice Recommendations (EPICC integrity tools) and the case management practice manuals, the PEPsy-CM check-list questionnaire was developed to evaluate the practice of case management in the EIS in France. This check-list contains different 35 items. The final score between 1(poor) to 5 (good) is established to determine the quality of the case management. Qualitative data are also collected during the interview with the participants.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nîmes, France, 30029
- Schandrin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Professional working in an early intervention center treating first episodes of psychosis
- Professional involved in the organization/management of the center or practicing case management.
Exclusion Criteria:
- Professional not working in the early intervention center
- Professional working in the early intervention center but not having a role in the organization or management of the center or as case manager
- Professional who does not take charge of people who have had a first psychotic episode
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
|
TIDieR checklist Patient - Use of the case management manual (yes or no)
|
1 year
|
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
|
TIDieR checklist Patient - Use of specific and validated tools for Psychoeducation (yes or no)
|
1 year
|
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
|
TIDieR checklist Patient - Use of an information brochure on First Episode Psychosis (yes or no)
|
1 year
|
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
|
TIDieR checklist Patient - Use of specific and validated tools to support families (yes or no)
|
1 year
|
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
|
TIDieR checklist Patient - Use of specific and validated tools for Motivational Interviewing (yes or no)
|
1 year
|
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
|
TIDieR checklist Patient - Presence of Individualized Therapeutic Plan (ITP) supervision system (yes or no)
|
1 year
|
conformity to TIDieR checklist in each center and for each case manager interviewed
Time Frame: 1 year
|
TIDieR checklist Patient - Use of Individualized Therapeutic Plan (ITP) supervision system (yes or no)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
description of the global organisation of each center
Time Frame: 1 year
|
Number of staff by trade
|
1 year
|
description of their involvement in the early intervention center
Time Frame: 1 year
|
number of years experience
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL/2022/RP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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