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Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01570712
Recruitment Status : Active, not recruiting
First Posted : April 4, 2012
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE April 2, 2012
First Posted Date  ICMJE April 4, 2012
Last Update Posted Date September 20, 2018
Study Start Date  ICMJE August 2011
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
healthcare utilisation [ Time Frame: 3 YEARS ]
hospitalizations, hospital days, and emergency department visits
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01570712 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France
Official Title  ICMJE Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France: a Multicentric Randomized Controlled Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Subnormal; Mental, Severe
Intervention  ICMJE
  • Other: HOUSING FIRST PROGRAM

    Realization of a psychosocial organic evaluation and a citizen;

    • Support in the development and the maintenance of the housing;
    • Support in the diverse steps (administrative, judicial, financiers, etc.);
    • Support around addictions / alcohol;
    • 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)
    • 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.
  • Other: traditional French services
    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
Study Arms  ICMJE
  • Experimental: Housing First Program
    Intervention: Other: HOUSING FIRST PROGRAM
  • Active Comparator: traditional French services
    Intervention: Other: traditional French services
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2012)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01570712
Other Study ID Numbers  ICMJE 2011-A00668-33
2011-12 ( Other Identifier: AP HM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: EMILIE GARRIDO PRADALIE Assistance Publique hôpitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP