Severe Psychiatric DisordersREDAPNCT02857296
Evaluative Research in the Process of Implementation of an Alternative Device to Hospitalization for People Homeless With Severe Psychiatric Disorders
An observational study of Severe Psychiatric Disorders, run by Assistance Publique Hopitaux De Marseille.
Trial summary
The research project aims to analyze the implementation of a new health care system - "alternative device to hospitalization and crisis home for people without home" - whose objective is to provide the homeless and suffering from severe psychiatric disorders adequate care to prevent situations from seeking care or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Psychiatric Disorders
- What is being tested?
- interview and observation
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults without home, with severe psychiatric disorders;
Who may be able to join
- Adults without home with severe psychiatric disorders utilizing the structure, adults who master the French language
Who cannot join
- adults not mastered the French language
Trial locations and contacts
No sites are listed yet.
About this study
The research project aims to analyze the implementation of a new health care system - "alternative device to hospitalization and crisis home for people without home" - whose objective is to provide the homeless and suffering from severe psychiatric disorders adequate care to prevent situations from seeking care or complication of their disease. This device, if it has the administrative and legal structure of the Twin Stop Health Care (LHSS), is based on the original concept of "Soteria House." This will build tools for evaluating the performance of care device by a process evaluation describing and analyzing what activity involves the device, This research seeks to analyze the experimental device in the early stages of its implementation. The observation and analysis of the program period will adjust the management arrangements of the device. The data and conclusions from this research will identify the contributions and benefits of such a device and analyze the difficulties encountered in its implementation.
- Conditions
- Severe Psychiatric Disorders
- Being tested
- interview and observation
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interview and observationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
socio-anthropological survey
Biographical interviews and three du'entretiens targeted series on the course therapy will be conducted
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Psychiatric DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857296
- Sponsor's protocol ID
- RC12_3681 - 5325
- Acronym
- REDAP
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluative Research in the Process of Implementation of an Alternative Device to Hospitalization for People Homeless With Severe Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT02857296
- Acronym / sponsor ID
- REDAP / RC12_3681 - 5325
- Conditions
- Severe Psychiatric Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research project aims to analyze the implementation of a new health care system - "alternative device to hospitalization and crisis home for people without home" - whose objective is to provide the homeless and suffering from severe psychiatric disorders adequate care to prevent situations from seeking care or complication of their disease. This device, if it has the administrative and legal structure of the Twin Stop Health Care (LHSS), is based on the original concept of "Soteria House." This will build tools for evaluating the performance of care device by a process evaluation describing and analyzing what activity involves the device, This research seeks to analyze the experimental device in the early stages of its implementation. The observation and analysis of the program period will adjust the management arrangements of the device. The data and conclusions from this research will identify the contributions and benefits of such a device and analyze the difficulties encountered in its implementation.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults without home, with severe psychiatric disorders;
Key inclusion criteria (1 listed)
- Adults without home with severe psychiatric disorders utilizing the structure, adults who master the French language
Key exclusion criteria (1 listed)
- adults not mastered the French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interview and observation | Other | – |
Primary outcome
socio-anthropological survey
Time frame: 1 year
Biographical interviews and three du'entretiens targeted series on the course therapy will be conducted
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Psychiatric Disorders, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aline SARRADON (04 91 38 27 47 ext. +33, drci@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
socio-anthropological survey (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.