RecoveryEQUARNCT06874439
An Evaluation of the WHO QUAlityRights Program
A study testing WHO QualityRights program in people with Recovery and Organization of Health Service, run by GCS-CCOMS at 10 sites in France.
Trial summary
The World Health Organization's (WHO) QualityRights (QR) program offers assessments and recommendations to help mental health facilities, on a voluntary basis, improve their care practices towards better respect of the rights of service users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recovery, Organization of Health Service, Mental Health Care
- What is being tested?
- WHO QualityRights program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 10 sitesFrance
- Study dates
- 17 Jun 2024to Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years or older)
- Persons having formulated a non-opposition to participate in the study
- Population a (users): Service users of the psychiatric sectors involved in the study hospitalized full-time since at least 3 days in an inpatient unit.
- Population b (professionals): Mental health professionals working in the sector since at least 3 months at the time of study participation
Who cannot join
- Persons physically or psychologically unable to participate at the time of the study
- Persons subject to a safeguard of justice measure
- Persons who do not speak or understand the French language
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Public mental health establishment of Lille Metropole (59G09/G10)
Armentières, 59280
Public mental health establishment of Lille Metropole (59G20)
Armentières, 59280
Hospital Centre of Erstein
Erstein, 67150
Psychotherapeutic Center of Nancy
Laxou, 54520
Hospital Centre Drôme Vivarais
Montéléger, 26760
Hospital Care Center of Nanterre
Nanterre, 92014
Hospital Centre Sainte-Marie Nice
Nice, 06100
Hospital Center of Plaisir (78G16)
Plaisir, 78370
Hospital Center of Plaisir (78G18)
Plaisir, 78370
Hospital Center of Candélie
Pont-du-Casse, 47480
About this study
The World Health Organization's (WHO) QualityRights (QR) program offers assessments and recommendations to help mental health facilities, on a voluntary basis, improve their care practices towards better respect of the rights of service users. The aim of this study is to evaluate the QR program in a French national context.
The main questions it aims to answer are:
- Does the QR program improve perceived satisfaction with care among mental health service users?
- What are the implementation procedures of the program?
- What is its budgetary impact?
Researchers will compare the QR program intervention with usual practices.
Read the detailed description
In France, despite the existence of recommendations and a restrictive legal framework, the use of restraint practices in psychiatry remains widespread, and the duration and conditions of hospitalization do not always guarantee respect for users' rights.
The World Health Organization's (WHO) QualityRights (QR) program offers assessments, called "observations", and recommendations to help mental health facilities, on a voluntary basis, improve their care practices towards better respect of the rights of service users. However, the program has never been evaluated in a French national context.
The WHO QR program, published in 2012 and regularly updated since, aims to improve the quality of care in mental health and related services and promote the rights of people with psychosocial, intellectual and cognitive disabilities.
The reference base for the tools that make up the program is the United Nations Convention on the Rights of Persons with Disabilities (CRPD), ratified by France in 2010. This international convention defines ambitious objectives in terms of respect for rights, some of which are particularly relevant to mental health services. However, the convention does not offer any concrete indications as to how these major international standards are to be applied.
The QR program provides a concrete response to this need, offering observation and training tools not only for mental health services, but more broadly for all those concerned by mental health issues. In particular, the observation methodology is designed to respond to a request for support in changing practices that comes directly from a facility.
The WHO Collaborating Centre in Lille is mandated by the WHO to roll out this program in France and other French-speaking countries. It is expected that the QualityRights approach will act as a lever for change in the organization of services, providing a multidisciplinary perspective on users' rights and recovery-oriented practices.
The primary research objective is to evaluate the effectiveness of the QR program on the perceived satisfaction with care of mental health service users.
The secondary research objectives concern:
- Evaluating the effectiveness of the QR program on:
- Improving work-related quality of life among mental health professionals
- Decreasing the number of involuntary admissions
- Reducing the length of full-time hospital stays
- Reducing the number of acts of seclusion and restraint
- The distribution of clinical activity in favour of ambulatory activity
- Evaluating the efficiency and the budgetary impact of the QR program.
- Conducting an implementation study to understand the appropriation of the recommendations by professionals and management following the introduction of the QR program by exploring the representations linked to the QR program and respect for users' rights among mental health professionals.
This research involves an effectiveness study, supplemented by an implementation study based on a qualitative methodology, and an economic evaluation.
The effectiveness study is a cluster randomized trial designed to compare the effectiveness of the QR program intervention versus usual practices on user satisfaction. The cluster is defined at the level of the psychiatric sector (the public psychiatric care entity organizing the mental health care of a population within a pre-specified geographical and demographic area in France, to meet local needs). 10 psychiatric sectors are participating, randomized into two groups: the intervention group receiving the QR program and the control group maintaining their usual practices.
Data will be collected in both groups at baseline, and during follow-up at 1 and 2 years. The implementation study and the economic evaluation will be carried out in the intervention group after the effectiveness study.
- Being tested
- WHO QualityRights program
- Keywords
- User rights, Recovery-oriented practices, Mental Health Settings, Satisfaction with care, Interventional study, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO QualityRights programOther
The WHO's QualityRights program involves an assessment, called observation, of mental health care services by an ephemeral multidisciplinary team, which provides feedback and recommendations for improving care practices. The observation team, trained in the QualityRights (QR) methodology, includes mental health professionals, researchers, legal experts, and management staff from mental health organizations. Each team always incorporates at least one expert by experience and one informal caregiver or family member. Participation in the program is voluntary and initiated at the request of healthcare facilities.
The observation is structured into three stages:
- Site preparation
- On-site observation
- Restitution of observation report and follow-up
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Sectors receiving the WHO QualityRights program Receives: Other: WHO QualityRights program |
| Usual practices | No intervention | Sectors not receiving the WHO QualityRights program, and maintaining usual practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with care
Service user satisfaction with care score assessed using the Verona Service Satisfaction Scale (VSSS-EU)
Measured: At baseline, at 1 year, and at 2 years
Secondary outcomes (13)
Work-related quality of life
Work-related quality of life score for mental health professionals assessed using the SERENAT scale
Measured: At baseline, at 1 year, and at 2 years
Involuntary psychiatric hospitalisations
Number of involuntary hospitalizations in the 6 months preceding the time point
Measured: At baseline, at 1 year, and at 2 years
Length of stay
Length of stay for each patient in the 6 months preceding the time points
Measured: At baseline, at 1 year, and at 2 years
Seclusion and restraint
Number of acts of seclusion and restraint in the 6 months preceding the time points
Measured: At baseline, at 1 year, and at 2 years
Distribution of hospital activity
Hospital case load and outpatient service utilization in the 6 months preceding the time points
Measured: At baseline, at 1 year, and at 2 years
Cost-utility
Incremental cost-utility ratio in cost per QALY gained (EQ-5D-5L questionnaire)
Measured: 24 months
Cost-effectiveness
Incremental cost-effectiveness ratio in cost per VSSS-EU score points gained
Measured: 24 months
Budgetary impact - costs
Costs associated with the generalization of the QR program
Measured: 5 years after hypothetical generalization
Budgetary impact - QALY
The number of QALYs will be calculated with and without the QR program to assess the gains associated with its generalization.
Measured: 5 years after hypothetical generalization
Budgetary impact - Involuntary psychiatric hospitalizations
The number of involuntary hospitalizations will be calculated with and without the QR program to assess the gains associated with its generalization.
Measured: 5 years after hypothetical generalization
Budgetary impact - Length of stay
The length of stay will be calculated with and without the QR program to assess the gains associated with its generalization.
Measured: 5 years after hypothetical generalization
Budgetary impact - Seclusion and restraint
The number of acts of seclusion and restraint will be calculated with and without the QR program to assess the gains associated with its generalization.
Measured: 5 years after hypothetical generalization
Implementation
Qualitative methods will be used through semi-structured interviews conducted with 10 mental health professionals per sector of the intervention group.
Measured: In the 1 year following the last time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start17 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecoveryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS-CCOMS
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM ECEVE 1123, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Déborah Sebbane, MD, PhD, Study chair, GCS-CCOMS & ECEVE 1123 INSERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874439
- Sponsor's protocol ID
- 2024-A00092-45
- Other IDs
- PREPS-22-0042
- Acronym
- EQUAR
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the WHO QUAlityRights Program
- ClinicalTrials.gov ID
- NCT06874439
- Acronym / sponsor ID
- EQUAR / 2024-A00092-45
- Keywords
- User rights, Recovery-oriented practices, Mental Health Settings, Satisfaction with care, Interventional study, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- GCS-CCOMSUniversity, hospital or other
- Collaborators
- INSERM ECEVE 1123, Assistance Publique - Hôpitaux de Paris
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 13 Mar 2025 (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.
The World Health Organization's (WHO) QualityRights (QR) program offers assessments and recommendations to help mental health facilities, on a voluntary basis, improve their care practices towards better respect of the rights of service users. The aim of this study is to evaluate the QR program in a French national context.
The main questions it aims to answer are:
- Does the QR program improve perceived satisfaction with care among mental health service users?
- What are the implementation procedures of the program?
- What is its budgetary impact?
Researchers will compare the QR program intervention with usual practices.
Detailed description
In France, despite the existence of recommendations and a restrictive legal framework, the use of restraint practices in psychiatry remains widespread, and the duration and conditions of hospitalization do not always guarantee respect for users' rights.
The World Health Organization's (WHO) QualityRights (QR) program offers assessments, called "observations", and recommendations to help mental health facilities, on a voluntary basis, improve their care practices towards better respect of the rights of service users. However, the program has never been evaluated in a French national context.
The WHO QR program, published in 2012 and regularly updated since, aims to improve the quality of care in mental health and related services and promote the rights of people with psychosocial, intellectual and cognitive disabilities.
The reference base for the tools that make up the program is the United Nations Convention on the Rights of Persons with Disabilities (CRPD), ratified by France in 2010. This international convention defines ambitious objectives in terms of respect for rights, some of which are particularly relevant to mental health services. However, the convention does not offer any concrete indications as to how these major international standards are to be applied.
The QR program provides a concrete response to this need, offering observation and training tools not only for mental health services, but more broadly for all those concerned by mental health issues. In particular, the observation methodology is designed to respond to a request for support in changing practices that comes directly from a facility.
The WHO Collaborating Centre in Lille is mandated by the WHO to roll out this program in France and other French-speaking countries. It is expected that the QualityRights approach will act as a lever for change in the organization of services, providing a multidisciplinary perspective on users' rights and recovery-oriented practices.
The primary research objective is to evaluate the effectiveness of the QR program on the perceived satisfaction with care of mental health service users.
The secondary research objectives concern:
- Evaluating the effectiveness of the QR program on:
- Improving work-related quality of life among mental health professionals
- Decreasing the number of involuntary admissions
- Reducing the length of full-time hospital stays
- Reducing the number of acts of seclusion and restraint
- The distribution of clinical activity in favour of ambulatory activity
- Evaluating the efficiency and the budgetary impact of the QR program.
- Conducting an implementation study to understand the appropriation of the recommendations by professionals and management following the introduction of the QR program by exploring the representations linked to the QR program and respect for users' rights among mental health professionals.
This research involves an effectiveness study, supplemented by an implementation study based on a qualitative methodology, and an economic evaluation.
The effectiveness study is a cluster randomized trial designed to compare the effectiveness of the QR program intervention versus usual practices on user satisfaction. The cluster is defined at the level of the psychiatric sector (the public psychiatric care entity organizing the mental health care of a population within a pre-specified geographical and demographic area in France, to meet local needs). 10 psychiatric sectors are participating, randomized into two groups: the intervention group receiving the QR program and the control group maintaining their usual practices.
Data will be collected in both groups at baseline, and during follow-up at 1 and 2 years. The implementation study and the economic evaluation will be carried out in the intervention group after the effectiveness study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: WHO QualityRights programSectors receiving the WHO QualityRights program |
| Usual practices | No intervention | –Sectors not receiving the WHO QualityRights program, and maintaining usual practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (18 years or older)
- Persons having formulated a non-opposition to participate in the study
- Population a (users): Service users of the psychiatric sectors involved in the study hospitalized full-time since at least 3 days in an inpatient unit.
- Population b (professionals): Mental health professionals working in the sector since at least 3 months at the time of study participation
Key exclusion criteria (3 listed)
- Persons physically or psychologically unable to participate at the time of the study
- Persons subject to a safeguard of justice measure
- Persons who do not speak or understand 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 |
|---|---|---|
| WHO QualityRights programThe WHO's QualityRights program involves an assessment, called observation, of mental health care services by an ephemeral multidisciplinary team, which provides feedback and recommendations for improving care practices. The observation team, trained in the QualityRights (QR) methodology, includes mental health professionals, researchers, legal experts, and management staff from mental health organizations. Each team always incorporates at least one expert by experience and one informal caregiver or family member. Participation in the program is voluntary and initiated at the request of healthcare facilities. The observation is structured into three stages: 1. Site preparation 2. On-site observation 3. Restitution of observation report and follow-up | Other | Intervention |
Primary outcome
Satisfaction with care
Time frame: At baseline, at 1 year, and at 2 years
Service user satisfaction with care score assessed using the Verona Service Satisfaction Scale (VSSS-EU)
13 secondary outcomes
Work-related quality of life
Time frame: At baseline, at 1 year, and at 2 years
Involuntary psychiatric hospitalisations
Time frame: At baseline, at 1 year, and at 2 years
Length of stay
Time frame: At baseline, at 1 year, and at 2 years
Seclusion and restraint
Time frame: At baseline, at 1 year, and at 2 years
Distribution of hospital activity
Time frame: At baseline, at 1 year, and at 2 years
Cost-utility
Time frame: 24 months
Cost-effectiveness
Time frame: 24 months
Budgetary impact - costs
Time frame: 5 years after hypothetical generalization
Budgetary impact - QALY
Time frame: 5 years after hypothetical generalization
Budgetary impact - Involuntary psychiatric hospitalizations
Time frame: 5 years after hypothetical generalization
Budgetary impact - Length of stay
Time frame: 5 years after hypothetical generalization
Budgetary impact - Seclusion and restraint
Time frame: 5 years after hypothetical generalization
Implementation
Time frame: In the 1 year following the last time point
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 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Recovery
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
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.
Déborah Sebbane, MD, PhD study chair
GCS-CCOMS & ECEVE 1123 INSERM
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO QualityRights program in people with Recovery and Organization of Health Service, run by GCS-CCOMS at 10 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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?
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?
Satisfaction with care (time frame: At baseline, at 1 year, and at 2 years). 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 15 Oct 2026.