Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT05385666
Status:
UNKNOWN
Last Update Posted:
2022-08-25
First Post:
2022-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collaborative Mental Health Care Model: an Evaluation of the Implementation of a Pilot in Four Primary Care Organization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2022-05-12', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the first implementation in France of collaborative care for frequent psychic disorders', 'timeFrame': '36 months', 'description': 'numbers of patients and medical caregivers who participate in collaborative care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Disorder']}, 'descriptionModule': {'briefSummary': 'Frequent mental disorders (anxiety or mood disorders), an important part of primary care patient care, remain insufficiently detected and treated. Improving their care requires better coordination between general practice and specialized care. The collaborative care model developed in Washington State with the introduction of a care manager is recognized. About 100 randomized controlled trials have established its effectiveness and efficiency, in terms of improving the progression of disorders (remission rate), adherence, quality of life, professional and patient satisfaction, and cost savings. However, the possibility of implementation of these validated care remains to be explored. A dozen collaborative care implementation studies exist, all conducted in the USA and not having considered all the dimensions of the indicators of penetration, acceptability/adoption, feasibility, fidelity and cost. A first implementation in France is implemented since September 2021 in the Yvelines department on four sites of different size, organization and environments: the multi-professional health centers (MSP) of Mureaux and Celle St Cloud, the Chevreuse medical house and MG in isolated practice in Versailles.\n\nThe main objective of the research project is to evaluate the first implementation in France of collaborative care for frequent psychic disorders according to the indicators of penetration, acceptability/adoption, fidelity, relevance, feasibility and cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthcare professionals involved in the collaborative care system\n* patients who have been referred for collaborative care by their family physician\n\nExclusion Criteria:\n\n* patient refusal to participate in research\n* adults protected by law'}, 'identificationModule': {'nctId': 'NCT05385666', 'acronym': 'Mosaique', 'briefTitle': 'Collaborative Mental Health Care Model: an Evaluation of the Implementation of a Pilot in Four Primary Care Organization', 'organization': {'class': 'OTHER', 'fullName': 'Versailles Hospital'}, 'officialTitle': 'Collaborative Mental Health Care Model: an Evaluation of the Implementation of a Pilot in Four Health Homes', 'orgStudyIdInfo': {'id': 'P21/10_mosaïque'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group experimental', 'interventionNames': ['Other: collaborative cares']}], 'interventions': [{'name': 'collaborative cares', 'type': 'OTHER', 'description': 'coordinate care between city medicine and specialized psychiatric care to improve the management of common mental disorders', 'armGroupLabels': ['group experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78460', 'city': 'Chevreuse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie Anne Duval-Cattaneo', 'role': 'CONTACT'}], 'facility': 'Maison de Santé Pluridisciplinaire', 'geoPoint': {'lat': 48.70662, 'lon': 2.03329}}, {'zip': '78130', 'city': 'Les Mureaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'marie Hélène certain', 'role': 'CONTACT'}], 'facility': 'Maison de Santé Pluridisciplinaire', 'geoPoint': {'lat': 48.99173, 'lon': 1.90972}}, {'zip': '78000', 'city': 'Versailles', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'xavier gayraud', 'role': 'CONTACT'}], 'facility': 'Cabinet Médical Versailles', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}, {'zip': '78000', 'city': 'Versailles', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'laurent de bastard', 'role': 'CONTACT'}], 'facility': 'cabinet médical Versailles', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}, {'zip': '78000', 'city': 'Versailles', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'jerome barre', 'role': 'CONTACT'}], 'facility': 'Cabinet Médical Versailles', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}], 'centralContacts': [{'name': 'nadia Younes', 'role': 'CONTACT', 'email': 'nyounes@ch-versailles.fr', 'phone': '01 39 63 83 12'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Nadia YOUNES', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator Coordinator', 'investigatorFullName': 'Dr Nadia YOUNES', 'investigatorAffiliation': 'Versailles Hospital'}}}}