- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01570712
Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France
19. september 2018 opdateret af: Assistance Publique Hopitaux De Marseille
Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France: a Multicentric Randomized Controlled Study
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
600
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Marseille, Frankrig, 13354
- Assistance Publique Hopitaux de Marseille
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
aged over 18;
- 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.
- living with schizophrenia or bipolar disorder (diagnosis of DSM-IV);
- with a sufficient understanding of written and spoken French to be able to provide informed consent and to participate to face-to-face interviews;
- affiliated to a social protection;
- who have lived in the city targeted for at least 6 months and willing to stand in the city during the 2 next years;
- with a global score measured on Multnomah Community Ability Scale (MCAS) (scale <=62 (high need criteria));
- 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).
Exclusion Criteria:
- being considered unable to provide informed consent;
- having dependent children;
- pregnancy;
- or a DSM-IV Axis I diagnosis other than schizophrenia or bipolar disorder
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Housing First Program
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Realization of a psychosocial organic evaluation and a citizen;
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Aktiv komparator: traditional French services
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
healthcare utilisation
Tidsramme: 3 YEARS
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hospitalizations, hospital days, and emergency department visits
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3 YEARS
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2011
Primær færdiggørelse (Faktiske)
1. maj 2016
Studieafslutning (Forventet)
1. juni 2019
Datoer for studieregistrering
Først indsendt
2. april 2012
Først indsendt, der opfyldte QC-kriterier
3. april 2012
Først opslået (Skøn)
4. april 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. september 2018
Sidst verificeret
1. september 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011-A00668-33
- 2011-12 (Anden identifikator: AP HM)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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