Mental DisorderEVA-DLAINCT06636474
Evaluation of the Supported Housing System for the Inclusion of People Suffering From Mental Disorders
A study testing patients with mental disorders in people with Mental Disorder, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
Access to housing, in the current context of extreme tension in the rental housing market in Paris and throughout the Ile-de-France region, is proving to be extremely complex for people with mental health problems.National and international scientific studies have quantified the problem of homelessness and precarious… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mental Disorder
- What is being tested?
- patients with mental disorders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2020to 27 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patient followed for a psychiatric disorder patient benefiting from a DLAI
Who cannot join
- patient not followed for psychiatric disorder patient who refused to participate in the research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Sainte Anne
Paris, 75014
Alexandra PHAM - SCOTTEZ, MD, +33 145 65 89 18, a.pham@ch-sainte-anne.fr
Alexandra PHAM - SCOTTEZ, MD
About this study
Access to housing, in the current context of extreme tension in the rental housing market in Paris and throughout the Ile-de-France region, is proving to be extremely complex for people with mental health problems.National and international scientific studies have quantified the problem of homelessness and precarious or inappropriate housing among patients suffering from psychiatric disorders, and show the impact of housing problems on the consumption of psychiatric care.The DÉLAI's mission is to facilitate access to housing for people enrolled in a psychiatric care pathway, with teams from the psychiatric sectors
Read the detailed description
- Written and oral information provided to the patient by the patient's referring psychiatrist (Investigator of one of the five recruiting sites) during a regular consultation appointment.
- Initial assessment (V inclusion): reminder of the information concerning the research, collection of consent, collection of sociodemographic data, and standardized assessment scales (quality of life, clinical state, level of functioning) + standardized semi-structured interview for the diagnosis of psychiatric disorders + completion by the referring psychiatrist of the data corresponding to the patient's care pathway.
- Then follow-up visit at an annual rate (V1 ... VX), and DLAI exit assessment (V exit) as soon as the patient stops benefiting from the DLAI.
- Conditions
- Mental Disorder
- Being tested
- patients with mental disorders
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with mental disordersOther
administration of standardized questionnaires and scales, upon entering the research, then annually, and finally upon leaving the research
| Study group | Role | What they receive |
|---|---|---|
| patients with mental disorders | Other | administration of standardized questionnaires and scales, upon entering the research, then annually, and finally upon leaving the research Receives: Other: patients with mental disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of quality of life
World Health Organization Quality of Life-26,26-item self-assessment questionnaire for assessing quality of life covering four major dimensions: physical health, mental health, social relationships and environment
Measured: one year
improvement of quality of life
quality of life rating scale (each item is rated from 0 to 6, giving a total score out of 42 points), assessing interpersonal relationships (relationships with close acquaintances and social initiatives), social status, intrapsychic functioning (degree of motivation, anhedonia and capacity for empathy) and regular activities.
Measured: one year
Secondary outcomes (1)
clinical condition
Mini International Neuropsychiatric Interview : structured diagnostic interview, relatively short in duration, exploring in a standardized way the main psychiatric disorders
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start27 Jul 2020
- Primary completion27 Jul 2030 (estimated)
- Study completion27 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe 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
- Model description
- All patients benefiting from a DLAI and suffering from psychiatric disorders, monitored in sector 75G08-09 of the Saint-Maurice hospitals, and sectors 75G19, 75G20-21, 75G25, 75G26 of the GHU Paris.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636474
- Sponsor's protocol ID
- D20-P007
- Acronym
- EVA-DLAI
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Supported Housing System for the Inclusion of People Suffering From Mental Disorders
- ClinicalTrials.gov ID
- NCT06636474
- Acronym / sponsor ID
- EVA-DLAI / D20-P007
- Conditions
- Mental Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 27 Jul 2030 (estimated)
- Study completion
- 27 Dec 2030 (estimated)
- First posted
- 10 Oct 2024 (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.
Access to housing, in the current context of extreme tension in the rental housing market in Paris and throughout the Ile-de-France region, is proving to be extremely complex for people with mental health problems.National and international scientific studies have quantified the problem of homelessness and precarious or inappropriate housing among patients suffering from psychiatric disorders, and show the impact of housing problems on the consumption of psychiatric care.The DÉLAI's mission is to facilitate access to housing for people enrolled in a psychiatric care pathway, with teams from the psychiatric sectors
Detailed description
- Written and oral information provided to the patient by the patient's referring psychiatrist (Investigator of one of the five recruiting sites) during a regular consultation appointment.
- Initial assessment (V inclusion): reminder of the information concerning the research, collection of consent, collection of sociodemographic data, and standardized assessment scales (quality of life, clinical state, level of functioning) + standardized semi-structured interview for the diagnosis of psychiatric disorders + completion by the referring psychiatrist of the data corresponding to the patient's care pathway.
- Then follow-up visit at an annual rate (V1 ... VX), and DLAI exit assessment (V exit) as soon as the patient stops benefiting from the DLAI.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients benefiting from a DLAI and suffering from psychiatric disorders, monitored in sector 75G08-09 of the Saint-Maurice hospitals, and sectors 75G19, 75G20-21, 75G25, 75G26 of the GHU Paris.
| Arm | Type | Receives |
|---|---|---|
| patients with mental disorders | Other | Other: patients with mental disordersadministration of standardized questionnaires and scales, upon entering the research, then annually, and finally upon leaving the research |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patient followed for a psychiatric disorder patient benefiting from a DLAI
Key exclusion criteria (1 listed)
- patient not followed for psychiatric disorder patient who refused to participate in the research
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 |
|---|---|---|
| patients with mental disordersadministration of standardized questionnaires and scales, upon entering the research, then annually, and finally upon leaving the research | Other | patients with mental disorders |
Primary outcome
improvement of quality of life
Time frame: one year
World Health Organization Quality of Life-26,26-item self-assessment questionnaire for assessing quality of life covering four major dimensions: physical health, mental health, social relationships and environment
improvement of quality of life
Time frame: one year
quality of life rating scale (each item is rated from 0 to 6, giving a total score out of 42 points), assessing interpersonal relationships (relationships with close acquaintances and social initiatives), social status, intrapsychic functioning (degree of motivation, anhedonia and capacity for empathy) and regular activities.
1 secondary outcome
clinical condition
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patients with mental disorders in people with Mental Disorder, run by Centre Hospitalier St Anne at 1 site in France.
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: looking for participants now, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra PHAM-scottez, Pr (+ 33 (0)1 45 65 83 70 / 81 08, a.pham@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of quality of life (time frame: one year). The study lists 2 primary outcomes in all. 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 10 Oct 2024.