- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03992105
Alternative Care to the Accompaniment Called "Place of Respite" in the Resolution of the Psychotic Crises of Homeless People With Severe Mental Pathology
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 Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: historical cohort
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.
|
topics included openly in the "Respite Site", made up of the first 50 subjects followed prospectively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Needs Assessement
Time Frame: 36 months
|
Scoring the Montreal Assement Need questionnaire
|
36 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-33
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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