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Alternative Care to the Accompaniment Called "Place of Respite" in the Resolution of the Psychotic Crises of Homeless People With Severe Mental Pathology

Primary Purpose

Mental Health

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
prospective cohort
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Over 18 years old Diagnosed with schizophrenia, bipolar I disorder, or schizoaffective disorder according to the DSMIV classification Homeless "ETHOS 1 or 2" (FEANTSA classification) In a crisis situation: psychiatric crisis (PANSS increase of more than 20%), social crisis (significant alteration of social relations) Affiliated to a social protection scheme Accepting to participate in the study An HCAT score greater than or equal to 3

Exclusion Criteria:

Under 18 years old Participant in another study simultaneously in accordance with Article L112112 of the public health code Refusing to participate in the study, or whose legal representative refuses to participate in the study in the case of a person under guardianship or curatorship A score on the HCAT scale (decision-making competence) strictly less than 3

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    historical cohort

    Arm Description

    150 homeless patients in crisis, identified from an extraction of the database of psychiatric emergencies of the same territory, and matched for age, sex, and main diagnosis.

    Outcomes

    Primary Outcome Measures

    Needs Assessement
    Scoring the Montreal Assement Need questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    June 18, 2019
    Last Updated
    June 18, 2019
    Sponsor
    Assistance Publique Hopitaux De Marseille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03992105
    Brief Title
    Alternative Care to the Accompaniment Called "Place of Respite" in the Resolution of the Psychotic Crises of Homeless People With Severe Mental Pathology
    Official Title
    Alternative Device to the Accompaniment Called "Place of Respite" in the Resolution of the Psychotic Crises of the People Without a Severe Mental Pathology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    December 30, 2019 (Anticipated)
    Study Completion Date
    October 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique Hopitaux De Marseille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Document the effectiveness of the "Respite Site" program in relation to the current health system. Document in particular the number and type of constraints, lengths of hospitalization and mode of exit, as well as the exit destination of psychotic homeless people.
    Detailed Description
    Between 2012 and 2015, the practice of "stress-related care" related to crisis situations increased by 15%, with about 90,000 people under duress making France one of the European countries where practice most under stress. Being homeless, from a visible ethnic minority, combined with the lack of alternatives in the territory are well-documented risk factors for being hospitalized under duress. A review of the 2015 literature has shown that out-of-hospital crisis sites achieve results equivalent to those of conventional hospitalization in terms of reduced symptomatology and would have better outcomes in terms of increase in remission and recovery times of professional activity and social inclusion, with greater efficiency. In Marseille, an experimental device has shown its capacity to propose an alternative to hospitalization, for this type of population.Running the lessons of this experiment and inspired by the experimentation Parachute, a new device experimental, called "Place of respite", This place proposes a model of resolution of the psychotic crisis where the person decides the type of care that she wish to receive. It is a device that is therefore an alternative to conventional psychiatric care under duress. The investigators formulate the hypothesis that alternative support to the resolution of the crisis by using the skills of people with disorders severe psychiatric conditions in the experimental "Respite site" decreases in the short term the number of hospitalizations and their duration, as well as the experience of the constraint in the course of care of these people, compared to the subjects who did not benefit from this device and could represent a model of crisis management / psychiatric emergency efficient with regard to the current offer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Health

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    historical cohort
    Arm Type
    Other
    Arm Description
    150 homeless patients in crisis, identified from an extraction of the database of psychiatric emergencies of the same territory, and matched for age, sex, and main diagnosis.
    Intervention Type
    Other
    Intervention Name(s)
    prospective cohort
    Intervention Description
    topics included openly in the "Respite Site", made up of the first 50 subjects followed prospectively
    Primary Outcome Measure Information:
    Title
    Needs Assessement
    Description
    Scoring the Montreal Assement Need questionnaire
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Over 18 years old Diagnosed with schizophrenia, bipolar I disorder, or schizoaffective disorder according to the DSMIV classification Homeless "ETHOS 1 or 2" (FEANTSA classification) In a crisis situation: psychiatric crisis (PANSS increase of more than 20%), social crisis (significant alteration of social relations) Affiliated to a social protection scheme Accepting to participate in the study An HCAT score greater than or equal to 3 Exclusion Criteria: Under 18 years old Participant in another study simultaneously in accordance with Article L112112 of the public health code Refusing to participate in the study, or whose legal representative refuses to participate in the study in the case of a person under guardianship or curatorship A score on the HCAT scale (decision-making competence) strictly less than 3

    12. IPD Sharing Statement

    Learn more about this trial

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