Bipolar Disorder Type I or II (According to DSM-5)AppEduc-BDNCT04775498
Psychoeducation Programmes - Patients With Bipolar Disorder
A study testing Face-to-face psychoeducation group and SIMPLe mobile application in people with Bipolar Disorder Type I or II (According to DSM-5), run by University Hospital, Clermont-Ferrand at 10 sites in France.
Trial summary
This is a controlled, randomized, prospective, open-label, non-inferiority trial lasting 12 months. The effectiveness of using a psychoeducational smartphone application (SIMPLe) will be compared to the effectiveness of face-to-face group psychoeducation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder Type I or II (According to DSM-5)
- What is being tested?
- Face-to-face psychoeducation group and SIMPLe mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 10 sitesFrance
- Study dates
- 1 Feb 2021to 1 Feb 2025
- 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
- Suffering from bipolar disorder (type 1 or 2) according to DSM-5 criteria
- Not presenting a mood episode according to DSM-5 criteria
- Stable for at least 1 month with scores on YMRS < 8 and MADRS < 8
- Owning a smartphone
- Agreeing to attend group psychoeducation sessions
- Having no problem understanding fluent French
- Having given free and informed consent and signed the consent to participate in the study
- Available for 12 onth follow-up
Who cannot join
- Not having a smartphone compatible with the SIMPLe application
- Cannot attend psychoeducation group sessions on a regular basis
- Not having given their consent to participate in the study or unable to give their informed consent
- Not affiliation with a social security scheme
- Having a legal protection measure (safeguard of justice or guardianship)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites, 10 recruiting
- Not yet recruiting
CH Charles Perrens
Bordeau, 33076
Sebastien Gard, sgard@ch-perrens.fr
- Recruiting
CHU - Gabriel Montpied
Clermont-Ferrand, 63000
Samalin Ludovic, lsamalin@chu-clermontferrand.fr
Pierre-Michel Llorca, pmllorca@chu-clermontferrand.fr
- Not yet recruiting
CHU - Hôpital Lapeyronie
Montpellier, 34295
Emilie Olié, e-olie@chu-montpellier.fr
- Not yet recruiting
CHU
Nantes, 44000
Anne Sauvaget, anne.oiry@univ-nantes.fr
- Not yet recruiting
CHU - Hôpital Universitaire Carémeau
Nîmes, 30029
Mocrane Abbar, mocrane.abbar@chu-nimes.fr
- Not yet recruiting
APHP - Hôpital Fernand-Widal
Paris, 75010
Sébastien Etain, bruno.etain@inserm.fr
- Not yet recruiting
CH Saint-Anne
Paris, 75674
Philip Gorwood
- Not yet recruiting
APHP - Centre Hospitalier Henri Mondor
Paris, 94010
Marion Leboyer, marion.leboyer@inserm.fr
- Not yet recruiting
CHI HC site rives du Doubs Pontarlier
Pontarlier, 25304
Andreea Marinescu
- Not yet recruiting
CHU - Hôpital de Psychiatrie
Toulouse, 31059
Antoine Yrondi, yrondi.a@chu-toulouse.fr
About this study
Official title: Non-inferiority Study Comparing Two Psychoeducation Programmes (Mobile Application Versus Face-to-face Psychoeducation Group) in a Population of Patients With Bipolar Disorder
This is a controlled, randomized, prospective, open-label, non-inferiority trial lasting 12 months. The effectiveness of using a psychoeducational smartphone application (SIMPLe) will be compared to the effectiveness of face-to-face group psychoeducation.
Read the detailed description
Bipolar disorder (affecting 3 to 5% of French population) is characterized by the recurrence of severe symptomatic periods (depression, mania, hypomania) and interepisodic periods characterized by the persistence of residual symptoms, impaired psychosocial functioning and quality of life. The combination of psychosocial strategies with drug treatment is associated with an improvement in the prognosis of the disease. Among these complementary strategies, psychoeducation has been shown to be effective in reducing the risk of recurrence, the length of hospital stays and improving compliance. It improves an individual's understanding and knowledge of their disorder and its various treatments. Despite its effectiveness, psychoeducation for bipolar disorder remains relatively scarcely applied in France due to a limited healthcare offer (44 available programmes labeled by the Regional Health Agencies in 2017).
In recent years, a significant number of smartphone applications have been developed in the field of mental health. To date, none of these applications has proven effective in patients with bipolar disorder. In this context, the Institute of Neuroscience of Barcelona has developed a "SIMPLe" application to assess and record a subject's symptoms and deliver personalized psychoeducation. In terms of efficacy, a study has shown the interest of this application in improving biological rhythms, thereby reducing the risk of relapse and improving psychosocial functioning and the quality of life of patients suffering from bipolar disorder in remission phase. This application has been translated and adapted into French as part of a partnership with the Barcelona Institute of Neuroscience. However, the benefits of this type of application in terms of effectiveness, accessibility or reduction of health costs have never been studied in comparison to face-to-face psychoeducation programmes. This research project therefore represents a real opportunity to evaluate for the first time the effectiveness of an application allowing the delivery of personalized psychoeducation in comparison to a face-to-face group psychoeducation program (reference treatment for relapse prevention).
The SIMPLe app includes 5 daily questions (mood, energy, sleep, irritability, medication adherence) that will assess different areas associated with bipolar disorder. The user will also receive a weekly test to determine the presence and intensity of depressive or manic symptoms. Daily and personalized psychoeducation messages (adapted to the answers to the tests carried out) will be sent to the user by notifications. The app contains a bank of around 400 psychoeducational messages, based on Prof. Vieta and Dr Colom's Psychoeducation Manual for Bipolar Disorders.
Eligible patients, after obtaining their consent, will be randomized (i) either in the face-to-face psychoeducation group which will consist of the participation by the patients in all the sessions of a therapeutic education program (labeled and controlled by their Regional Health Agency) of the investigator center, (ii) or in the SIMPLe application group and will benefit from access to the application via a code that will be sent to them.
Three additional visits to the usual care are planned (assessment visit, 6 months and 12 months). At each visit, patients must complete questionnaires (CSRI, YMRS, MADRS, FAST, MARS, WHOQOL-BREF and EQ-5D).
The hypothesis formulated by the investigator is that a psychoeducational strategy using the SIMPLe smartphone application has an effect comparable to participation in a face-to-face psychoeducation group, in term of the recurrence prevention in a sample of stabilized patients with bipolar disorder (at 12 months). The recurrence rate is defined by the percentage of patients having presented a mood episode of bipolar disorder, namely a major depressive episode, manic or hypomanic episode, according to the criteria of DSM-5 and on the basis of the judgment of the clinician since the beginning of the intervention.
- Being tested
- Face-to-face psychoeducation group, SIMPLe mobile application
- Keywords
- Bipolar disorder, Psychoeducation, Mobile application, Smartphone, Recurrence prevention
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face psychoeducation groupBehavioural
All of the investigation centers participating in this study have a psychoeducation programme on bipolar disorders labeled and monitored by their Regional Health Agency. For this, he must respect the decree of January 14, 2015 relating to the specifications of therapeutic education programs for the patient. Patients will be receive by an investigator, for inclusion and baseline evaluation and at 6 and 12 months after inclusion. During this meeting, investigator and patient will be complete 7 questionnaires (about disease, treatment observance and quality of life), investigator will collect treatment, style life and adverse event(s).
SIMPLe mobile applicationBehavioural
The experimental intervention consists of 12 months use SIMPLe smartphone application who has been developed by the Barcelona Institute of neuroscience. The purpose of this application is to deliver individualized psychoeducation messages to the patient's clinical condition. The psychoeducational messages correspond to the contents of the different modules and sessions carried out in face-to-face psychoeducation groups (Colomm \& Vieta ; 2015). Patients will be receive by an investigator for inclusion and baseline evaluation, at 6 and 12 months after inclusion. During this meeting, investigator and patient will be complete 7 questionnaires (about disease, treatment observance and quality of life), investigator will collect treatment, style life and adverse event(s).
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face psychoeducation group | Active comparator | The group of face-to-face psychoeducation or standard intervention will consist of the participation by the patients include in all the sessions of a therapeutic education programme of the investigator center. Receives: Behavioral: Face-to-face psychoeducation group |
| SIMPLe mobile application | Experimental | The experimental intervention consists of the use of the SIMPLe application during 1 year: answers of 5 daily questions and to the weekly questions. Moreover, daily and personalized psychoeducation messages (adapted to the answers to the tests carried out) will be sent to user by notifications. Receives: Behavioral: SIMPLe mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Measure the difference of recurrence rate (defined by the percentage of patients having presented a mood episode of bipolar disorder, namely a major depressive episode, manic or hypomanic episode, according to the criteria of DSM-5 and on the judgment of the clinician since the beginning of the intervention) between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application
Measured: 12 months after inclusion
Secondary outcomes (14)
Hospitalization number
Measure the difference of number and duration of hospitalization between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application
Measured: 6 months after inclusion
Hospitalization number
Measure the difference of number and duration of hospitalization between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application
Measured: 12 months after inclusion
Maniac and depressive symptomatology intensity
Measure the difference of maniac and depressive symptomatology intensity between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application. These measures are based on YMRS (for maniac symptomatology) questionnaire.
Measured: 6 months after inclusion.
Maniac and depressive symptomatology intensity
Measure the difference of maniac and depressive symptomatology intensity between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application. These measures are based on YMRS (for maniac symptomatology) questionnaire.
Measured: 12 months after inclusion.
Maniac and depressive symptomatology intensity
Measure the difference of maniac and depressive symptomatology intensity between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application. These measures are based on MADRS (for depressive symptomatology) questionnaires.
Measured: 6 months after inclusion.
Maniac and depressive symptomatology intensity
Measure the difference of medication compliance between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application. This measure is based on MARS (Medication Adherence Report Scale) questionnaire.
Measured: 6 months after inclusion.
Medication compliance
Measure the difference of medication compliance between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application. This measure is based on MARS (Medication Adherence Report Scale) questionnaire.
Measured: 12 months after inclusion.
Psychosocial functioning
Measure the difference of psychosocial functioning between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application. This measure is based on FAST (Functional Analysis Screening Tool ) questionnaire.
Measured: 6 months after inclusion.
Psychosocial functioning
Measure the difference of psychosocial functioning between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application. This measure is based on FAST (Functional Analysis Screening Tool ) questionnaire.
Measured: 12 months after inclusion.
Evaluation of Quality of life
Measure the difference of quality of life between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application. This measure is based on WHOQOL-BREF (World Health Organization Quality of Life) questionnaire.
Measured: 6 months ater inclusion
Evaluation of Quality of life
Measure the difference of quality of life between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application. This measure is based on WHOQOL-BREF (World Health Organization Quality of Life) questionnaire.
Measured: 12 months ater inclusion
Cost efficiency
Cost efficiency evaluation of SIMPLe application using CSRI (Client Service Receipt Inventory) questionnaire
Measured: 12 month after inclusion
Cost / utility ratio
Evaluation of cost / utility ratio of SIMPLe application using the EQ-5D (EuroQol 5 Dimensions) questionnaire.
Measured: 12 month after inclusion
Qualitative analysis
Some patients of SIMPLe application group (4 womens and 4 mens < 30 years, 4 womens and 4 mens 30 to 50 years and 4 womens and 4 mens > 50 years) will participate in an individual interview. These semi-structured individual interviews will be carried out by a psychologist. During these interviews the perception and use of the SIMPLe application by patients will be gathered (both positive opinions and negative criticisms and possible obstacles to its use).
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder Type I or II (According to DSM-5)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Standard group : patients will participate at all sessions of face-to-face psychoeducation (sessions labeled and controlled by their Regional Health Agency). * Experimental group: patients will use SIMPLe application during 12 months.
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludovic Samalin, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775498
- Sponsor's protocol ID
- PREPS 2017 SAMALIN
- Acronym
- AppEduc-BD
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 1 Mar 2021
- 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 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study Comparing Two Psychoeducation Programmes (Mobile Application Versus Face-to-face Psychoeducation Group) in a Population of Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT04775498
- Acronym / sponsor ID
- AppEduc-BD / PREPS 2017 SAMALIN
- Keywords
- Bipolar disorder, Psychoeducation, Mobile application, Smartphone, Recurrence prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 1 Mar 2021 (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.
This is a controlled, randomized, prospective, open-label, non-inferiority trial lasting 12 months. The effectiveness of using a psychoeducational smartphone application (SIMPLe) will be compared to the effectiveness of face-to-face group psychoeducation.
Detailed description
Bipolar disorder (affecting 3 to 5% of French population) is characterized by the recurrence of severe symptomatic periods (depression, mania, hypomania) and interepisodic periods characterized by the persistence of residual symptoms, impaired psychosocial functioning and quality of life. The combination of psychosocial strategies with drug treatment is associated with an improvement in the prognosis of the disease. Among these complementary strategies, psychoeducation has been shown to be effective in reducing the risk of recurrence, the length of hospital stays and improving compliance. It improves an individual's understanding and knowledge of their disorder and its various treatments. Despite its effectiveness, psychoeducation for bipolar disorder remains relatively scarcely applied in France due to a limited healthcare offer (44 available programmes labeled by the Regional Health Agencies in 2017).
In recent years, a significant number of smartphone applications have been developed in the field of mental health. To date, none of these applications has proven effective in patients with bipolar disorder. In this context, the Institute of Neuroscience of Barcelona has developed a "SIMPLe" application to assess and record a subject's symptoms and deliver personalized psychoeducation. In terms of efficacy, a study has shown the interest of this application in improving biological rhythms, thereby reducing the risk of relapse and improving psychosocial functioning and the quality of life of patients suffering from bipolar disorder in remission phase. This application has been translated and adapted into French as part of a partnership with the Barcelona Institute of Neuroscience. However, the benefits of this type of application in terms of effectiveness, accessibility or reduction of health costs have never been studied in comparison to face-to-face psychoeducation programmes. This research project therefore represents a real opportunity to evaluate for the first time the effectiveness of an application allowing the delivery of personalized psychoeducation in comparison to a face-to-face group psychoeducation program (reference treatment for relapse prevention).
The SIMPLe app includes 5 daily questions (mood, energy, sleep, irritability, medication adherence) that will assess different areas associated with bipolar disorder. The user will also receive a weekly test to determine the presence and intensity of depressive or manic symptoms. Daily and personalized psychoeducation messages (adapted to the answers to the tests carried out) will be sent to the user by notifications. The app contains a bank of around 400 psychoeducational messages, based on Prof. Vieta and Dr Colom's Psychoeducation Manual for Bipolar Disorders.
Eligible patients, after obtaining their consent, will be randomized (i) either in the face-to-face psychoeducation group which will consist of the participation by the patients in all the sessions of a therapeutic education program (labeled and controlled by their Regional Health Agency) of the investigator center, (ii) or in the SIMPLe application group and will benefit from access to the application via a code that will be sent to them.
Three additional visits to the usual care are planned (assessment visit, 6 months and 12 months). At each visit, patients must complete questionnaires (CSRI, YMRS, MADRS, FAST, MARS, WHOQOL-BREF and EQ-5D).
The hypothesis formulated by the investigator is that a psychoeducational strategy using the SIMPLe smartphone application has an effect comparable to participation in a face-to-face psychoeducation group, in term of the recurrence prevention in a sample of stabilized patients with bipolar disorder (at 12 months). The recurrence rate is defined by the percentage of patients having presented a mood episode of bipolar disorder, namely a major depressive episode, manic or hypomanic episode, according to the criteria of DSM-5 and on the basis of the judgment of the clinician since the beginning of the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Standard group : patients will participate at all sessions of face-to-face psychoeducation (sessions labeled and controlled by their Regional Health Agency). * Experimental group: patients will use SIMPLe application during 12 months.
| Arm | Type | Receives |
|---|---|---|
| Face-to-face psychoeducation group | Active comparator | Behavioral: Face-to-face psychoeducation groupThe group of face-to-face psychoeducation or standard intervention will consist of the participation by the patients include in all the sessions of a therapeutic education programme of the investigator center. |
| SIMPLe mobile application | Experimental | Behavioral: SIMPLe mobile applicationThe experimental intervention consists of the use of the SIMPLe application during 1 year: answers of 5 daily questions and to the weekly questions. Moreover, daily and personalized psychoeducation messages (adapted to the answers to the tests carried out) will be sent to user by notifications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Suffering from bipolar disorder (type 1 or 2) according to DSM-5 criteria
- Not presenting a mood episode according to DSM-5 criteria
- Stable for at least 1 month with scores on YMRS < 8 and MADRS < 8
- Owning a smartphone
- Agreeing to attend group psychoeducation sessions
Key exclusion criteria (5 listed)
- Not having a smartphone compatible with the SIMPLe application
- Cannot attend psychoeducation group sessions on a regular basis
- Not having given their consent to participate in the study or unable to give their informed consent
- Not affiliation with a social security scheme
- Having a legal protection measure (safeguard of justice or guardianship)
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 |
|---|---|---|
| Face-to-face psychoeducation groupAll of the investigation centers participating in this study have a psychoeducation programme on bipolar disorders labeled and monitored by their Regional Health Agency. For this, he must respect the decree of January 14, 2015 relating to the specifications of therapeutic education programs for the patient. Patients will be receive by an investigator, for inclusion and baseline evaluation and at 6 and 12 months after inclusion. During this meeting, investigator and patient will be complete 7 questionnaires (about disease, treatment observance and quality of life), investigator will collect treatment, style life and adverse event(s). | Behavioural | Face-to-face psychoeducation group |
| SIMPLe mobile applicationThe experimental intervention consists of 12 months use SIMPLe smartphone application who has been developed by the Barcelona Institute of neuroscience. The purpose of this application is to deliver individualized psychoeducation messages to the patient's clinical condition. The psychoeducational messages correspond to the contents of the different modules and sessions carried out in face-to-face psychoeducation groups (Colomm \& Vieta ; 2015). Patients will be receive by an investigator for inclusion and baseline evaluation, at 6 and 12 months after inclusion. During this meeting, investigator and patient will be complete 7 questionnaires (about disease, treatment observance and quality of life), investigator will collect treatment, style life and adverse event(s). | Behavioural | SIMPLe mobile application |
Primary outcome
Recurrence rate
Time frame: 12 months after inclusion
Measure the difference of recurrence rate (defined by the percentage of patients having presented a mood episode of bipolar disorder, namely a major depressive episode, manic or hypomanic episode, according to the criteria of DSM-5 and on the judgment of the clinician since the beginning of the intervention) between patients who participated to face-to-face psychoeducation group and patients who use SIMPLe application
14 secondary outcomes
Hospitalization number
Time frame: 6 months after inclusion
Hospitalization number
Time frame: 12 months after inclusion
Maniac and depressive symptomatology intensity
Time frame: 6 months after inclusion.
Maniac and depressive symptomatology intensity
Time frame: 12 months after inclusion.
Maniac and depressive symptomatology intensity
Time frame: 6 months after inclusion.
Maniac and depressive symptomatology intensity
Time frame: 6 months after inclusion.
Medication compliance
Time frame: 12 months after inclusion.
Psychosocial functioning
Time frame: 6 months after inclusion.
Psychosocial functioning
Time frame: 12 months after inclusion.
Evaluation of Quality of life
Time frame: 6 months ater inclusion
Evaluation of Quality of life
Time frame: 12 months ater inclusion
Cost efficiency
Time frame: 12 month after inclusion
Cost / utility ratio
Time frame: 12 month after inclusion
Qualitative analysis
Time frame: 12 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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.
Ludovic Samalin principal investigator
University Hospital, Clermont-Ferrand
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face psychoeducation group and SIMPLe mobile application in people with Bipolar Disorder Type I or II (According to DSM-5), run by University Hospital, Clermont-Ferrand 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 8 inclusion and 5 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 1 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (33.4.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 12 months after inclusion). 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 1 Mar 2021.