Severe Mental DisorderPASSVERS-2NCT05274126
Implementation of a Social and Mental Health Support to Promote Recovery in Five Mental Health Facilities in Paris Area
A study testing Patient group/Passvers in people with Severe Mental Disorder, run by Versailles Hospital at 5 sites in France.
Trial summary
Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures evolution during the implementation of recovery based intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Mental Disorder
- What is being tested?
- Patient group/Passvers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesFrance
- Study dates
- 1 May 2022to 1 May 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a severe and persistent mental disorder among the following ICD10 compliant diagnostic categories:
- Schizophrenia spectrum disorder (F2x)
- Recurrent or persistent mood disorders (F30.x, F31.x, F33.x, F34.x, F38.x)
- Psychological developmental disorders including autism spectrum disorders (F8x) and childhood and adolescent onset disorders (F9x)
- Presence of an indication for inclusion in the rehabilitation project identified by the treating psychiatrist and endorsed in the inclusion session by the PASSVers staff.
- Written consent from the patient or his/her legal representative to participate in the study.
Who cannot join
- Presence of an not stabilized or progressive organic neurological pathology, neurodegenerative disease
- Psychological or behavioral disorders mainly related to addictions with substances
- Psychiatric disorders secondary to an organic pathology that is not stabilized or that is evolving
- The following psychiatric situations are reasons for non-inclusion in the absence of an argued and collegial reassessment (the reason being that, although PASSVers2 must be considered as a first intention proposal in many situations meeting the inclusion criteria, it cannot intervene or be thought of as a "solution" to certain complex situations):
- Psychiatric disorders caused by pregnancy or immediate postpartum
- Severe borderline personality disorder
Show all 11Show fewer
- Current suicidal crisis
- Extreme fragility of the patient with respect to changes that may be induced by the project, associated with a high risk of self or hetero-aggression.
- Patient under justice constraint
- Foreseeable departure from the geographic area, not allowing for certainty of further evaluation
- Refusal of the patient to be followed by a social-health team (i.e. refusal of care or refusal of a dialogue on social aspects and projects).
Trial locations and contacts
5 sites in 1 country.
Eric Brunet-Gouet, MD PhD contact
5 sites in 1 country
France5 sites
Centre Hospitalier d'Argenteuil, secteurs 95G05, 95G06, 95G13,
Argenteuil
Dr Lamisse, MD
Hôpital Sainte Anne - GHU Paris Psychiatrie & Neurosciences, secteur G75015
Paris
Dr de Maricourt, MD
Centre Hospitalier de Plaisir, secteur 78G16, CMP de Rambouillet
Rambouillet
Dr Omnès, MD
Etablissement de Santé Mentale de Rueil-Malmaison, Groupe MGEN, secteur 92G13, CMP de Rueil-Malmaison
Rueil-Malmaison
Dr Matthieu, MD
Centre Hospitalier de Versailles, secteur 78G17, Centre Bleuler, Versailles
Versailles
Dr Bratu, MD
About this study
Official title: Implantation Sur Cinq Centres Médico-Psychologiques Franciliens du Parcours Socio-Sanitaire orienté Vers le Rétablissement (PASSVers2)
Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures evolution during the implementation of recovery based intervention.
Read the detailed description
This is a hybrid efficacy-implementation Type I recovery based interventional study based on a multicenter follow-up of a cohort of 300 patients with severe and persistent mental disorders (60 patients per center). The evolution of concepts and means of evaluation now allow a precise description of the mechanisms of recovery in all the diversity of its expression among patients, their entourages and the psychiatric facilities.
In the present study, the investigators aim to characterize simultaneously the patients' trajectories and the evolution of the care facilities and their professionals with respect to the principles of recovery. This double exploration should allow to build theoretical and practical references for the extension of this approach to other centers in France.
The study considers a dual timeline for data collection:
- The timeline associated with patients defined by the inclusion of each patient and extending to 24 months after, punctuated by an assessment at 12 months;
- The timeline of the inclusion centers and professionals involved in the rehabilitation projects defined by the beginning of the study and extending beyond the end of inclusion of the last patient, punctuated by annual intermediate evaluations of the means allocated by the structure and the positioning of the personnel in terms of recovery.
The intervention consists in a follow-up of the patients and their relatives by a psychiatric nurse and a social worker during 12 months. Both professionals, trained to rehabilitation and recovery principles, will focus on the patient's needs and goals in order to improve the outcome, quality-of-life and clinical status.
- Conditions
- Severe Mental Disorder
- Being tested
- Patient group/Passvers
- Keywords
- Schizophrenia, Bipolar disorder, Autism
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient group/PassversBehavioural
Passvers intervention aims at :
- helping patients followed in the centers, presenting a Severe and Persistent Mental Disorder (schizophrenia, mood disorder, autism spectrum disorder, etc.), at risk or in a situation of psychological disability, to enroll in a rehabilitation program towards recovery.
- supporting the emergence and construction of projects by the people themselves, and to accompany them to realize them.
- Encouraging the use of resources in their environment and common law mechanisms (city hall, department, associations, etc.) for better social integration.
- encouraging involvement in care understood as useful tools for the realization of the personal project.
Passvers also aims at :
- promoting a change in professional practices within the team, in favor of recovery-oriented practices based on the concept of engagement or empowerment.
- allowing cooperation between health and social structures aiming at destigmatizing mental illness.
| Study group | Role | What they receive |
|---|---|---|
| Patient group (single group) | Experimental | 300 Patients involved in the recovery process. Receives: Behavioral: Patient group/Passvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self rating of recovery support by caregivers T0
5-item short version of INSPIRE measure (Brief INSPIRE), range from 5 to 25, 25 corresponds to maximal support
Measured: baseline
Patient self rating of recovery support by caregivers T12
5-item short version of INSPIRE measure (Brief INSPIRE), range from 5 to 25, 25 corresponds to maximal support
Measured: 1 year
Patient self rating of recovery support by caregivers and structure T0
Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
Measured: baseline
Patient self rating of recovery support by caregivers and structure T12
Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
Measured: 1 year
Patient functioning T0
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Measured: baseline
Patient functioning T12
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Measured: 1 year
Patient functioning T24
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Measured: 2 years
Patient self rating of quality of life T0
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Measured: baseline
Patient self rating of quality of life T12
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Measured: 1 year
Patient self rating of quality of life T24
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Measured: 2 years
Psychotic symptoms T0
Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
Measured: baseline
Psychotic symptoms T12
Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
Measured: 1 year
Depression T0
Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
Measured: baseline
Depression T12
Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
Measured: 1 year
Clinical outcome T0: Clinically significant events
Record of occurrences (boolean) and dates of any clinical event (hospitalizations, self-harming behavior) occurring during the course of the illness
Measured: baseline
Clinical outcome T12: Clinically significant events
Record of occurrences (boolean) and dates of any clinical event (hospitalizations, self-harming behavior) occurring during the course of the illness
Measured: 1 year
Patient self rating of recovery T0
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Measured: baseline
Patient self rating of recovery T12
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Measured: 1 year
Patient self rating of recovery T24
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Measured: 2 years
Secondary outcomes (20)
Professional's Recovery knowledge on patients T0
Recovery knowledge inventory (RKI), range 20-100, higher values correspond to better knowledge on recovery processes
Measured: baseline
Professional's Recovery knowledge on patients T12
Recovery knowledge inventory (RKI), range 20-100, higher values correspond to better knowledge on recovery processes
Measured: 1 year
Professional's Recovery opinions on patients T0
Practitioners' Beliefs, Goals and Practices in Psychiatric Rehabilitation (PBGP), range 26-104, higher values correspond to better views on patients recovery
Measured: baseline
Professional's Recovery opinions on patients T12
Practitioners' Beliefs, Goals and Practices in Psychiatric Rehabilitation (PBGP), range 26-104, higher values correspond to better views on patients recovery
Measured: 1 year
Stigmatization T0
Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception
Measured: baseline
Stigmatization T12
Internalized stigma of mental illness: self-stigma (ISMI), range 29-116, higher values correspond to worse stigmatization perception
Measured: 1 year
Perceived needs T0
Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help
Measured: baseline
Perceived needs T12
Perceived needs scale (ELADEB), Composite measure of perceived difficulty in meeting needs and needs of help
Measured: 1 year
Goal achievement T12
Goal achievement scale (GAS), range -2 to +2, higher values correspond to better achievement of one specific goal
Measured: 1 year
Metacognitive strategies T0
Versailles Metacognitive Strategies Evaluation Questionnaire (V-MSEQ), range 25-175, higher values correspond to better metacognitive strategies
Measured: baseline
Sleep T0
Patient self rating of sleep (1 item Pittsburgh sleep quality index PSQI), range 1-4, lower values correspond to better sleep quality
Measured: baseline
Sleep T12
Patient self rating of sleep (1 item Pittsburgh sleep quality index PSQI), range 1-4, lower values correspond to better sleep quality
Measured: 1 year
Medication adherence T0
Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment
Measured: baseline
Medication adherence T12
Medication Adherence Rating Scale (MARS), range 5-25, lower values correspond to better adherence to treatment
Measured: 1 year
Illness severity T0
Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness
Measured: baseline
Illness severity T12
Clinical Global Impressions Scale (CGI-S), range 1-7, higher values correspond to more severe illness
Measured: 1 year
Cognitive disability T0
Cognitive processes involved in disability in schizophrenia scale (CPSD), range 0-78, higher values correspond to better cognitive functioning
Measured: baseline
Cognitive disability T12
Cognitive processes involved in disability in schizophrenia scale (CPSD), range 0-78, higher values correspond to better cognitive functioning
Measured: 1 year
Entourage assessment of structure recovery orientation T0
Recovery Self-Assessment Significant other version (RSA-R entourage), range 40-200, higher values correspond to better recovery orientation
Measured: baseline
Entourage assessment of structure recovery orientation T12
Recovery Self-Assessment Significant other version (RSA-R entourage), range 40-200, higher values correspond to better recovery orientation
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 posted10 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Mental DisorderStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agence régionale de santé Ile de France, UNION NATIONALE DE FAMILLES ET AMIS DE PERSONNES MALADES ET/OU HANDICAPÉES PSYCHIQUES
- Responsible party
- Principal investigator, Dr Christine PASSERIEUX, Versailles Hospital
- Investigators
- Christine Passerieux, Prof, Principal investigator, CH Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274126
- Sponsor's protocol ID
- P20/03_ PASSVERS-2
- Acronym
- PASSVERS-2
- Status last verified
- Mar 2022
- First submitted
- 15 Feb 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bazin, N. Les suivis sociosanitaires des personnes présentant un trouble mental sévère et persistant : expérimentation PASSVers à Versailles. Inf. Psychiatr. 95, 509-513 (2019).
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation Sur Cinq Centres Médico-Psychologiques Franciliens du Parcours Socio-Sanitaire orienté Vers le Rétablissement (PASSVers2)
- ClinicalTrials.gov ID
- NCT05274126
- Acronym / sponsor ID
- PASSVERS-2 / P20/03_ PASSVERS-2
- Conditions
- Severe Mental Disorder
- Keywords
- Schizophrenia, Bipolar disorder, Autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Collaborators
- Agence régionale de santé Ile de France, UNION NATIONALE DE FAMILLES ET AMIS DE PERSONNES MALADES ET/OU HANDICAPÉES PSYCHIQUES
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 10 Mar 2022 (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.
Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures evolution during the implementation of recovery based intervention.
Detailed description
This is a hybrid efficacy-implementation Type I recovery based interventional study based on a multicenter follow-up of a cohort of 300 patients with severe and persistent mental disorders (60 patients per center). The evolution of concepts and means of evaluation now allow a precise description of the mechanisms of recovery in all the diversity of its expression among patients, their entourages and the psychiatric facilities.
In the present study, the investigators aim to characterize simultaneously the patients' trajectories and the evolution of the care facilities and their professionals with respect to the principles of recovery. This double exploration should allow to build theoretical and practical references for the extension of this approach to other centers in France.
The study considers a dual timeline for data collection:
- The timeline associated with patients defined by the inclusion of each patient and extending to 24 months after, punctuated by an assessment at 12 months;
- The timeline of the inclusion centers and professionals involved in the rehabilitation projects defined by the beginning of the study and extending beyond the end of inclusion of the last patient, punctuated by annual intermediate evaluations of the means allocated by the structure and the positioning of the personnel in terms of recovery.
The intervention consists in a follow-up of the patients and their relatives by a psychiatric nurse and a social worker during 12 months. Both professionals, trained to rehabilitation and recovery principles, will focus on the patient's needs and goals in order to improve the outcome, quality-of-life and clinical status.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures.
| Arm | Type | Receives |
|---|---|---|
| Patient group (single group) | Experimental | Behavioral: Patient group/Passvers300 Patients involved in the recovery process. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of a severe and persistent mental disorder among the following ICD10 compliant diagnostic categories:
- Presence of an indication for inclusion in the rehabilitation project identified by the treating psychiatrist and endorsed in the inclusion session by the PASSVers staff.
- Written consent from the patient or his/her legal representative to participate in the study.
Key exclusion criteria (11 listed)
- Presence of an not stabilized or progressive organic neurological pathology, neurodegenerative disease
- Psychological or behavioral disorders mainly related to addictions with substances
- Psychiatric disorders secondary to an organic pathology that is not stabilized or that is evolving
- The following psychiatric situations are reasons for non-inclusion in the absence of an argued and collegial reassessment (the reason being that, although PASSVers2 must be considered as a first intention proposal in many situations meeting the inclusion criteria, it cannot intervene or be thought of as a "solution" to certain complex situations):
- Foreseeable departure from the geographic area, not allowing for certainty of further evaluation
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 |
|---|---|---|
| Patient group/PassversPassvers intervention aims at : * helping patients followed in the centers, presenting a Severe and Persistent Mental Disorder (schizophrenia, mood disorder, autism spectrum disorder, etc.), at risk or in a situation of psychological disability, to enroll in a rehabilitation program towards recovery. * supporting the emergence and construction of projects by the people themselves, and to accompany them to realize them. * Encouraging the use of resources in their environment and common law mechanisms (city hall, department, associations, etc.) for better social integration. * encouraging involvement in care understood as useful tools for the realization of the personal project. Passvers also aims at : * promoting a change in professional practices within the team, in favor of recovery-oriented practices based on the concept of engagement or empowerment. * allowing cooperation between health and social structures aiming at destigmatizing mental illness. | Behavioural | Patient group (single group) |
Primary outcome
Patient self rating of recovery support by caregivers T0
Time frame: baseline
5-item short version of INSPIRE measure (Brief INSPIRE), range from 5 to 25, 25 corresponds to maximal support
Patient self rating of recovery support by caregivers T12
Time frame: 1 year
5-item short version of INSPIRE measure (Brief INSPIRE), range from 5 to 25, 25 corresponds to maximal support
Patient self rating of recovery support by caregivers and structure T0
Time frame: baseline
Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
Patient self rating of recovery support by caregivers and structure T12
Time frame: 1 year
Recovery Self-Assessment (RSA-R), range from 32 to 160, higher values correspond to more perceived help
Patient functioning T0
Time frame: baseline
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Patient functioning T12
Time frame: 1 year
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Patient functioning T24
Time frame: 2 years
Personal and Social Performance scale (PSP), range 0-100, 100 corresponds to better functioning
Patient self rating of quality of life T0
Time frame: baseline
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Patient self rating of quality of life T12
Time frame: 1 year
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Patient self rating of quality of life T24
Time frame: 2 years
Shortened quality of life questionnaire (SQoL-18), range 18-90, higher values correspond to better quality of life
Psychotic symptoms T0
Time frame: baseline
Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
Psychotic symptoms T12
Time frame: 1 year
Positive and negative syndrome scale (PANSS), range 30-210, higher values correspond to higher symptoms levels
Depression T0
Time frame: baseline
Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
Depression T12
Time frame: 1 year
Psychiatric symptoms scales rated by the clinicians (CDSS), range 0-27, higher values correspond to higher depressive symptoms
Clinical outcome T0: Clinically significant events
Time frame: baseline
Record of occurrences (boolean) and dates of any clinical event (hospitalizations, self-harming behavior) occurring during the course of the illness
Clinical outcome T12: Clinically significant events
Time frame: 1 year
Record of occurrences (boolean) and dates of any clinical event (hospitalizations, self-harming behavior) occurring during the course of the illness
Patient self rating of recovery T0
Time frame: baseline
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Patient self rating of recovery T12
Time frame: 1 year
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
Patient self rating of recovery T24
Time frame: 2 years
Questionnaire about the process of recovery (QPR), range from 22 to 110, higher values correspond to better recovery
20 secondary outcomes
Professional's Recovery knowledge on patients T0
Time frame: baseline
Professional's Recovery knowledge on patients T12
Time frame: 1 year
Professional's Recovery opinions on patients T0
Time frame: baseline
Professional's Recovery opinions on patients T12
Time frame: 1 year
Stigmatization T0
Time frame: baseline
Stigmatization T12
Time frame: 1 year
Perceived needs T0
Time frame: baseline
Perceived needs T12
Time frame: 1 year
Goal achievement T12
Time frame: 1 year
Metacognitive strategies T0
Time frame: baseline
Sleep T0
Time frame: baseline
Sleep T12
Time frame: 1 year
Medication adherence T0
Time frame: baseline
Medication adherence T12
Time frame: 1 year
Illness severity T0
Time frame: baseline
Illness severity T12
Time frame: 1 year
Cognitive disability T0
Time frame: baseline
Cognitive disability T12
Time frame: 1 year
Entourage assessment of structure recovery orientation T0
Time frame: baseline
Entourage assessment of structure recovery orientation T12
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- BackgroundBazin, N. Les suivis sociosanitaires des personnes présentant un trouble mental sévère et persistant : expérimentation PASSVers à Versailles. Inf. Psychiatr. 95, 509-513 (2019).
- Individual participant dataSharing planned: No
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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.
Eric Brunet-Gouet, MD PhD contact
Christine Passerieux, Prof principal investigator
CH Versailles
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient group/Passvers in people with Severe Mental Disorder, run by Versailles Hospital at 5 sites 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 6 inclusion and 11 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginie Bulot, MD (33 1 39 63 90 11, vbulot@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient self rating of recovery support by caregivers T0 (time frame: baseline). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274126, which also lists 1 linked publication.
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 25 Mar 2022.