- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01570712
Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France
19. september 2018 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
600
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Marseille, Frankrike, 13354
- Assistance Publique Hôpitaux de Marseille
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2011
Primær fullføring (Faktiske)
1. mai 2016
Studiet fullført (Forventet)
1. juni 2019
Datoer for studieregistrering
Først innsendt
2. april 2012
Først innsendt som oppfylte QC-kriteriene
3. april 2012
Først lagt ut (Anslag)
4. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. september 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. september 2018
Sist bekreftet
1. september 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2011-A00668-33
- 2011-12 (Annen identifikator: AP HM)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .