Mental HealthNCT03992105
Alternative Care to the Accompaniment Called "Place of Respite" in the Resolution of the Psychotic Crises of Homeless People With Severe Mental Pathology
A study testing prospective cohort in people with Mental Health, run by Assistance Publique Hopitaux De Marseille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- prospective cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Oct 2020
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Mental Health
- Being tested
- prospective cohort
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective cohortOther
topics included openly in the "Respite Site", made up of the first 50 subjects followed prospectively
| Study group | Role | What they receive |
|---|---|---|
| historical cohort | Other | 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. Receives: Other: prospective cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needs Assessement
Scoring the Montreal Assement Need questionnaire
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992105
- Sponsor's protocol ID
- 2019-33
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03992105
- Acronym / sponsor ID
- 2019-33
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 20 Jun 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| historical cohort | Other | Other: prospective cohort150 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| prospective cohorttopics included openly in the "Respite Site", made up of the first 50 subjects followed prospectively | Other | historical cohort |
Primary outcome
Needs Assessement
Time frame: 36 months
Scoring the Montreal Assement Need questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing prospective cohort in people with Mental Health, 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 20 Jun 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needs Assessement (time frame: 36 months). 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 20 Jun 2019.