Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01570712
Status:
UNKNOWN
Last Update Posted:
2018-09-20
First Post:
2012-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-19', 'studyFirstSubmitDate': '2012-04-02', 'studyFirstSubmitQcDate': '2012-04-03', 'lastUpdatePostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'healthcare utilisation', 'timeFrame': '3 YEARS', 'description': 'hospitalizations, hospital days, and emergency department visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Subnormal; Mental, Severe']}, 'referencesModule': {'references': [{'pmid': '35125129', 'type': 'DERIVED', 'citation': "Loubiere S, Lemoine C, Boucekine M, Boyer L, Girard V, Tinland A, Auquier P; French Housing First Study Group. Housing First for homeless people with severe mental illness: extended 4-year follow-up and analysis of recovery and housing stability from the randomized Un Chez Soi d'Abord trial. Epidemiol Psychiatr Sci. 2022 Feb 7;31:e14. doi: 10.1017/S2045796022000026."}, {'pmid': '34215235', 'type': 'DERIVED', 'citation': 'Tinland A, Loubiere S, Cantiello M, Boucekine M, Girard V, Taylor O, Auquier P. Mortality in homeless people enrolled in the French housing first randomized controlled trial: a secondary outcome analysis of predictors and causes of death. BMC Public Health. 2021 Jul 2;21(1):1294. doi: 10.1186/s12889-021-11310-w.'}, {'pmid': '32679400', 'type': 'DERIVED', 'citation': 'Loubiere S, Tinland A, Taylor O, Loundou A, Girard V, Boyer L, Auquier P. Determinants of healthcare use by homeless people with schizophrenia or bipolar disorder: results from the French Housing First Study. Public Health. 2020 Aug;185:224-231. doi: 10.1016/j.puhe.2020.05.019. Epub 2020 Jul 14.'}, {'pmid': '30423419', 'type': 'DERIVED', 'citation': 'Fond G, Boyer L, Boucekine M, Girard V, Loubiere S, Lenoir C, Auquier P, Tinland A; French Housing First Study Group. Illness and drug modifiable factors associated with violent behavior in homeless people with severe mental illness: results from the French Housing First (FHF) program. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 2;90:92-96. doi: 10.1016/j.pnpbp.2018.11.006. Epub 2018 Nov 10.'}, {'pmid': '29673362', 'type': 'DERIVED', 'citation': 'Rhenter P, Tinland A, Grard J, Laval C, Mantovani J, Moreau D, Vidaud B, Greacen T, Auquier P, Girard V. Problems maintaining collaborative approaches with excluded populations in a randomised control trial: lessons learned implementing Housing First in France. Health Res Policy Syst. 2018 Apr 19;16(1):34. doi: 10.1186/s12961-018-0305-1.'}, {'pmid': '28656452', 'type': 'DERIVED', 'citation': 'Tinland A, Zemmour K, Auquier P, Boucekine M, Girard V, Loubiere S, Fond G, Boyer L; French Housing First Study Group. Homeless women with schizophrenia reported lower adherence to their medication than men: results from the French Housing First experience. Soc Psychiatry Psychiatr Epidemiol. 2017 Sep;52(9):1113-1122. doi: 10.1007/s00127-017-1411-z. Epub 2017 Jun 27.'}, {'pmid': '24063556', 'type': 'DERIVED', 'citation': 'Tinland A, Fortanier C, Girard V, Laval C, Videau B, Rhenter P, Greacen T, Falissard B, Apostolidis T, Lancon C, Boyer L, Auquier P. Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial. Trials. 2013 Sep 24;14:309. doi: 10.1186/1745-6215-14-309.'}]}, 'descriptionModule': {'briefSummary': 'As mental health care shifted from state psychiatric hospitals to the community in France and western countries, the mental health system became inevitably involved in housing as it strove to meet the broader psychosocial needs of consumers. Simultaneously, as many consumers found themselves unable to find stable living in the community and struggling with addictions, they became a significant subgroup within a larger homeless population, which has received increasing policy attention over the past three decades. There are two distinct service models for adults who have severe mental illness and are homeless: the residential continuum model and the Housing First model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\naged over 18;\n\n* who are absolutely homeless or precariously housed. Absolutely homeless is defined as having had no fixed place to stay for at least the past seven nights with little likelihood of finding a place in the coming month. Precariously housed is defined as being housed a in single room occupancy, rooming house, or hotel/motel as a primary residence AND in the past year having experienced two or more episodes of being absolutely homeless OR one episode of being absolutely homeless that lasted for more than four weeks in the preceding 12 months.\n* living with schizophrenia or bipolar disorder (diagnosis of DSM-IV);\n* with a sufficient understanding of written and spoken French to be able to provide informed consent and to participate to face-to-face interviews;\n* affiliated to a social protection;\n* who have lived in the city targeted for at least 6 months and willing to stand in the city during the 2 next years;\n* with a global score measured on Multnomah Community Ability Scale (MCAS) (scale \\<=62 (high need criteria));\n* hospitalized at least twice on the past 12 months OR held in prison on the past 24 months OR presenting substance or alcohol abuse or dependence (high need criteria).\n\nExclusion Criteria:\n\n* being considered unable to provide informed consent;\n* having dependent children;\n* pregnancy;\n* or a DSM-IV Axis I diagnosis other than schizophrenia or bipolar disorder'}, 'identificationModule': {'nctId': 'NCT01570712', 'briefTitle': 'Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France: a Multicentric Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2011-A00668-33'}, 'secondaryIdInfos': [{'id': '2011-12', 'type': 'OTHER', 'domain': 'AP HM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Housing First Program', 'interventionNames': ['Other: HOUSING FIRST PROGRAM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional French services', 'interventionNames': ['Other: traditional French services']}], 'interventions': [{'name': 'HOUSING FIRST PROGRAM', 'type': 'OTHER', 'description': 'Realization of a psychosocial organic evaluation and a citizen;\n\n* Support in the development and the maintenance of the housing;\n* Support in the diverse steps (administrative, judicial, financiers, etc.);\n* Support around addictions / alcohol;\n* Supportin the family and social relations, in the environment of the person -to favor the occupational integration, by prioritizing the insertion in ordinary environment(middle)\n* to favor the access and the preservation of the patient to the psychiatric and somatic care, to the devices and the departments favoring the social insertion and the integration.', 'armGroupLabels': ['Housing First Program']}, {'name': 'traditional French services', 'type': 'OTHER', 'description': 'The person will not receive from intervention of the team of site, but the person can resort(turn) without limitation to all the range of services said " about "common law " set up in the direction of the persons homeless persons, as well as to every type of care. She can too reach the housing and\\\\or the restoring, but this by means of the existing devices', 'armGroupLabels': ['traditional French services']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'EMILIE GARRIDO PRADALIE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}