Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-03 @ 10:31 PM
Study NCT ID:
NCT05737966
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2022-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'conformity to TIDieR checklist in each center and for each case manager interviewed', 'timeFrame': '1 year', 'description': 'TIDieR checklist Patient - Use of the case management manual (yes or no)'}, {'measure': 'conformity to TIDieR checklist in each center and for each case manager interviewed', 'timeFrame': '1 year', 'description': 'TIDieR checklist Patient - Use of specific and validated tools for Psychoeducation (yes or no)'}, {'measure': 'conformity to TIDieR checklist in each center and for each case manager interviewed', 'timeFrame': '1 year', 'description': 'TIDieR checklist Patient - Use of an information brochure on First Episode Psychosis (yes or no)'}, {'measure': 'conformity to TIDieR checklist in each center and for each case manager interviewed', 'timeFrame': '1 year', 'description': 'TIDieR checklist Patient - Use of specific and validated tools to support families (yes or no)'}, {'measure': 'conformity to TIDieR checklist in each center and for each case manager interviewed', 'timeFrame': '1 year', 'description': 'TIDieR checklist Patient - Use of specific and validated tools for Motivational Interviewing (yes or no)'}, {'measure': 'conformity to TIDieR checklist in each center and for each case manager interviewed', 'timeFrame': '1 year', 'description': 'TIDieR checklist Patient - Presence of Individualized Therapeutic Plan (ITP) supervision system (yes or no)'}, {'measure': 'conformity to TIDieR checklist in each center and for each case manager interviewed', 'timeFrame': '1 year', 'description': 'TIDieR checklist Patient - Use of Individualized Therapeutic Plan (ITP) supervision system (yes or no)'}], 'secondaryOutcomes': [{'measure': 'description of the global organisation of each center', 'timeFrame': '1 year', 'description': 'Number of staff by trade'}, {'measure': 'description of their involvement in the early intervention center', 'timeFrame': '1 year', 'description': 'number of years experience'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['first episode of psychosis assertive community treatment', 'early intervention in mental health', 'case management', 'assertive community treatment'], 'conditions': ['First Episode Psychosis']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nA qualitative evaluation of case management practice in EIS seems essential to assess the impact of case managers under real conditions.\n\nBased 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Professional working in an early intervention center treating first episodes of psychosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Professional working in an early intervention center treating first episodes of psychosis\n* Professional involved in the organization/management of the center or practicing case management.\n\nExclusion Criteria:\n\n* Professional not working in the early intervention center\n* Professional working in the early intervention center but not having a role in the organization or management of the center or as case manager\n* Professional who does not take charge of people who have had a first psychotic episode'}, 'identificationModule': {'nctId': 'NCT05737966', 'acronym': 'CHECKLISTPEP', 'briefTitle': 'Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist', 'orgStudyIdInfo': {'id': 'LOCAL/2022/RP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'evaluation of professional practices', 'type': 'OTHER', 'description': 'Evaluation of professional practices : evaluation of the case management carried out in a program for early psychosis in France using a checklist according good practices guidelines'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Schandrin', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}