Suicide Attempt by ScaldingMED COMPANIONNCT03975881
Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted
A study testing application on smartphone in people with Suicide Attempt by Scalding, run by Nantes University Hospital at 3 sites in France.
Trial summary
Context: Suicide is the 2nd cause of death during adolescence Compliance with post SA care is low and variable with effective compliance ranging from 17.5% to 47% . Therefore, prevention programs should also focus on high-risk individuals with a previous history of SA. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Suicide Attempt by Scalding
- What is being tested?
- application on smartphone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jun 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Boy or girl, aged 15 to 35 years and having made a suicide attempt within 96 hours requiring emergency admission.
- Informed and signed consent of patient and parents (if applicable)
- Patient affiliated to social security
Who cannot join
- Patient with a severe psychiatric condition such as, schizophrenia, autistic spectrum disorder and antecedent of more than one suicide attempt (not counting this).
- Patient without smartphone under iOS (mobile operating system developed by Apple) or Android, or without easy access (eg boarding school, social center ...)
- Patient with an intellectual disability making it impossible to use the application (clinically estimated).
- Absence of motivation in relation to the study.
- Patient who does not want or can not give informed consent or understand it.
- Patient whose follow-up seems difficult for psychological, geographical or social reasons, according to the judgment of the investigator
- Not affiliated to social security
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU d'Angers
Angers
Bénédicte GOHIER, BeGoohier@chu-anger.fr
CH Poitiers
Poitiers
Ludovic Gicquel, ludovic.gicquel@ch-poitiers.fr
CH Rennes
Rennes
Dominique Drapier, d.drapier@ch-guillaumerenier.fr
About this study
Official title: Multicenter Open Pilot Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted
Context: Suicide is the 2nd cause of death during adolescence Compliance with post SA care is low and variable with effective compliance ranging from 17.5% to 47% . Therefore, prevention programs should also focus on high-risk individuals with a previous history of SA.
Adolescents and young adults are considered to be digital natives, they are therefore a relevant population for the testing of Smartphone Application.
Read more
Project: The Investigators propose an innovative and new approach to prevent SA and Suicide for patients, based on a mobile healthcare application.
The program is an add-on to the usual care process.
Study: In a multicentric randomized pilot study with 15 to 35 years-old patients having previous SA, the primary goal for pilot study is to observe the filling rate of the application (feasibility).
Read the detailed description
Suicide is the 2nd cause of death during adolescence in Europe (1.200/year, 7.9 % of deaths in this age group) and the prevalence of Lifetime Suicide Attempts (SA) in this population is 4.2%. Within a year of the SA, the repetition rate in adolescent populations ranges from 15% to 28%.
Post-SA management is crucial and treatment compliance is a major concern in adolescent populations. A French consensus psychiatric workgroup recommends that when patient is discharged from emergency room (ER) or hospitalization, it is important to organize health care. Unfortunately, these recommendations are imprecise and, moreover, from 40 to 77% of adolescents with previous SAs do not follow the recommendations of the post crisis program. In real clinical practice, patients barely follow the recommended treatment.
Reducing the SA repetition rate and increasing compliance with the recommended post-crisis program are two synergic issues.
The incredible and recent adoption of smartphone health applications (apps), that collect data (weight, exercises…) and allow the consumer to see graphs and diagrams, illustrates the sociological and psychological power of digital self-care and self-management. This phenomenon is particularly important for adolescents and young adults, who are considered to be digital natives. Medical experience is mainly based on the idea that is could be very useful to ask the patient to fill in scales or questionnaires on his/her smartphone instead of on a computer or a paper sheet. This is called Ecological Momentary Assessment (EMA) as it is a naturalistic method to access clinical data.
There are a few positive experiments in self-management (or self-care) using smartphone applications in psychiatry. In the field of suicide and mood disorders they have very interesting and promising results (high filling rates and better compliance to heath care programs). However, despite a few self-care aspects most of these apps are based on psycho-education programs and suffer in reality from lack of feedback.
Second field of apps use is Ecological Momentary intervention (EMI). Main idea is to use EMA data in algorithm in order to produce personalized comments and advises for patients. With the development of machine learning, it is obvious that EMI will have great implication in the future. There are few experiences with EMI but recent reviews all suggest that it is results are promising in mood disorders and anxiety.
The investigators are proposing an EMA + EMI new approach to prevent patient SA and Suicide based on a mobile healthcare application. This application is not connected. This is noticeably different then connected approach, using connected technology (phone, visual-phone and text messages) such as the Suicide Intervention Assisted by Message (SIAM) program, with text messages sent (sometimes automatically) by healthcare professionals to high-risk suicide subjects has shown positive preliminary results, with a reduced repetition rate. The App will be customised for each user when redeemed with a personal code provided by the practitioner. The App will collect data from the patient regarding anxiety, mood and sleep disorders twice a day (with a decreased frequence along the period of use), essentially based on analogic visual scales and drop-down lists. An algorithm-based feedback will pro-actively inform the patient with comments and advice based on WHO recommendations and/or associated with self-coping or Mindfulness practices. The aim is to position the smartphone application like a health care partner, it's name will be Medical Companion.
In order to assess the efficiency of the complete app the investigators will first lead a multicentre open pilot study with 6 months of follow-up in an adolescents and young adults population with a history of suicide attempts.
The application is an association of a "conventional" EMA program and an innovative algorithm-based response to the patient. Built on the notion of self-care, this app is not connected and the patient's responses are processed in the algorithm: (i) to provide feed-back regarding their mental state (contextualized, i.e. "you seem to be less anxious then yesterday") and, (ii) to advice them about what to do (for example "call a friend" "breath deeply 5 times in a row"…). Each mental status will be analysed by the Bayesian application algorithm. Regular evaluations are also provided on screen with easy to see graphs that might be viewed by the patient. These graphs could (and should) be seen by the psychiatrist, or psychologist involved in the Care as Usual program that all participants will still have. In sum, medical practitioners involved in the patient's usual care will have access to synthetic presentation of patient's responses and the investigators plan to ask participants about their experience.
- Conditions
- Suicide Attempt by Scalding
- Being tested
- application on smartphone
- Keywords
- Suicide attempts, digital device, adolescent, adults
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application on smartphoneOther
Also called MEDICAL COMPANION
The aim of this study is to test the feasibility of our approach of preventing suicide relapse with the use of a smartphone application.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Patients aged 15 to 35 who made a suicide attempt and went through the emergency departments of the participating hospitals (Nantes, Angers, Rennes and Poitiers). Receives: Other: application on smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the usage rate of the Medical Companion application over a period of 6 months.
Ratio calculation (r) : r = (number of uses done) / (number of uses expected)
Measured: 6 months
Secondary outcomes (8)
Evaluation of the use rate of the application over 6 months
Frequency of use of the application, data generated automatically by the internal program of the application Medical Companion
Measured: 6 months
Evaluation of the use rate of the application over 6 months
duration of use of the application
Measured: 6 months
Evaluation of suicidal ideation after 6 months of use of the application,
Rate of suicidal ideation at 6 months assessed by telephone call in families using ( 1 to 7)
Measured: 6 months
Evaluation of suicidal recidivism at 6 months
Rate of suicidal recidivism at 6 months evaluated by phone call in families
Measured: 6 months
Assessment of the compliance rate at recommended care
Rate of compliance to recommended care at discharge from hospital (number of appointments honored)
Measured: 6 months
Assessment of the compliance rate at recommended care
Rate of compliance to recommended care at 6 months evaluated by phone call in families
Measured: 6 months
Evaluation of the evolution of the level of sadness of the subject during the 6 months of follow-up
Visual Analogic scale (1 is bad to 10 is perfect ) generated automatically from the subject's responses by the application's internal program
Measured: 6 months
Evaluation of the evolution of the level of sleep disorders of the subject during the 6 months of follow-up
Visual Analogic scale (1 is bad to 10 is perfect ) generated automatically from the subject's responses by the application's internal program.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (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 Suicide Attempt by ScaldingStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients aged 15 to 35 who made a suicide attempt and went through the emergency departments of the participating hospitals (Nantes, Angers, Rennes and Poitiers).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers, Rennes University Hospital, Saint Antoine University Hospital, Université de Nantes, Poitiers University Hospital
- Responsible party
- Sponsor
- Investigators
- Fanny GOLLIER BRIANT, Study chair, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975881
- Sponsor's protocol ID
- RC18_0038
- Acronym
- MED COMPANION
- Status last verified
- May 2019
- First submitted
- 9 Apr 2018
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mouchabac S, Leray P, Adrien V, Gollier-Briant F, Bonnot O. Prevention of Suicidal Relapses in Adolescents With a Smartphone Application: Bayesian Network Analysis of a Preclinical Trial Using In Silico Patient Simulations. J Med Internet Res. 2021 Sep 30;23(9):e24560. doi: 10.2196/24560.
PubMed 34591030
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Open Pilot Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted
- ClinicalTrials.gov ID
- NCT03975881
- Acronym / sponsor ID
- MED COMPANION / RC18_0038
- Conditions
- Suicide Attempt by Scalding
- Keywords
- Suicide attempts, digital device, adolescent, adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Angers, Rennes University Hospital, Saint Antoine University Hospital, Université de Nantes, Poitiers University Hospital
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Context: Suicide is the 2nd cause of death during adolescence Compliance with post SA care is low and variable with effective compliance ranging from 17.5% to 47% . Therefore, prevention programs should also focus on high-risk individuals with a previous history of SA.
Adolescents and young adults are considered to be digital natives, they are therefore a relevant population for the testing of Smartphone Application.
Project: The Investigators propose an innovative and new approach to prevent SA and Suicide for patients, based on a mobile healthcare application.
The program is an add-on to the usual care process.
Study: In a multicentric randomized pilot study with 15 to 35 years-old patients having previous SA, the primary goal for pilot study is to observe the filling rate of the application (feasibility).
Detailed description
Suicide is the 2nd cause of death during adolescence in Europe (1.200/year, 7.9 % of deaths in this age group) and the prevalence of Lifetime Suicide Attempts (SA) in this population is 4.2%. Within a year of the SA, the repetition rate in adolescent populations ranges from 15% to 28%.
Post-SA management is crucial and treatment compliance is a major concern in adolescent populations. A French consensus psychiatric workgroup recommends that when patient is discharged from emergency room (ER) or hospitalization, it is important to organize health care. Unfortunately, these recommendations are imprecise and, moreover, from 40 to 77% of adolescents with previous SAs do not follow the recommendations of the post crisis program. In real clinical practice, patients barely follow the recommended treatment.
Reducing the SA repetition rate and increasing compliance with the recommended post-crisis program are two synergic issues.
The incredible and recent adoption of smartphone health applications (apps), that collect data (weight, exercises…) and allow the consumer to see graphs and diagrams, illustrates the sociological and psychological power of digital self-care and self-management. This phenomenon is particularly important for adolescents and young adults, who are considered to be digital natives. Medical experience is mainly based on the idea that is could be very useful to ask the patient to fill in scales or questionnaires on his/her smartphone instead of on a computer or a paper sheet. This is called Ecological Momentary Assessment (EMA) as it is a naturalistic method to access clinical data.
There are a few positive experiments in self-management (or self-care) using smartphone applications in psychiatry. In the field of suicide and mood disorders they have very interesting and promising results (high filling rates and better compliance to heath care programs). However, despite a few self-care aspects most of these apps are based on psycho-education programs and suffer in reality from lack of feedback.
Second field of apps use is Ecological Momentary intervention (EMI). Main idea is to use EMA data in algorithm in order to produce personalized comments and advises for patients. With the development of machine learning, it is obvious that EMI will have great implication in the future. There are few experiences with EMI but recent reviews all suggest that it is results are promising in mood disorders and anxiety.
The investigators are proposing an EMA + EMI new approach to prevent patient SA and Suicide based on a mobile healthcare application. This application is not connected. This is noticeably different then connected approach, using connected technology (phone, visual-phone and text messages) such as the Suicide Intervention Assisted by Message (SIAM) program, with text messages sent (sometimes automatically) by healthcare professionals to high-risk suicide subjects has shown positive preliminary results, with a reduced repetition rate. The App will be customised for each user when redeemed with a personal code provided by the practitioner. The App will collect data from the patient regarding anxiety, mood and sleep disorders twice a day (with a decreased frequence along the period of use), essentially based on analogic visual scales and drop-down lists. An algorithm-based feedback will pro-actively inform the patient with comments and advice based on WHO recommendations and/or associated with self-coping or Mindfulness practices. The aim is to position the smartphone application like a health care partner, it's name will be Medical Companion.
In order to assess the efficiency of the complete app the investigators will first lead a multicentre open pilot study with 6 months of follow-up in an adolescents and young adults population with a history of suicide attempts.
The application is an association of a "conventional" EMA program and an innovative algorithm-based response to the patient. Built on the notion of self-care, this app is not connected and the patient's responses are processed in the algorithm: (i) to provide feed-back regarding their mental state (contextualized, i.e. "you seem to be less anxious then yesterday") and, (ii) to advice them about what to do (for example "call a friend" "breath deeply 5 times in a row"…). Each mental status will be analysed by the Bayesian application algorithm. Regular evaluations are also provided on screen with easy to see graphs that might be viewed by the patient. These graphs could (and should) be seen by the psychiatrist, or psychologist involved in the Care as Usual program that all participants will still have. In sum, medical practitioners involved in the patient's usual care will have access to synthetic presentation of patient's responses and the investigators plan to ask participants about their experience.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients aged 15 to 35 who made a suicide attempt and went through the emergency departments of the participating hospitals (Nantes, Angers, Rennes and Poitiers).
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Other: application on smartphonePatients aged 15 to 35 who made a suicide attempt and went through the emergency departments of the participating hospitals (Nantes, Angers, Rennes and Poitiers). |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Boy or girl, aged 15 to 35 years and having made a suicide attempt within 96 hours requiring emergency admission.
- Informed and signed consent of patient and parents (if applicable)
- Patient affiliated to social security
Key exclusion criteria (7 listed)
- Patient with a severe psychiatric condition such as, schizophrenia, autistic spectrum disorder and antecedent of more than one suicide attempt (not counting this).
- Patient without smartphone under iOS (mobile operating system developed by Apple) or Android, or without easy access (eg boarding school, social center ...)
- Patient with an intellectual disability making it impossible to use the application (clinically estimated).
- Absence of motivation in relation to the study.
- Patient who does not want or can not give informed consent or understand it.
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 |
|---|---|---|
| application on smartphoneAlso: MEDICAL COMPANIONThe aim of this study is to test the feasibility of our approach of preventing suicide relapse with the use of a smartphone application. | Other | Open Label |
Primary outcome
Evaluate the usage rate of the Medical Companion application over a period of 6 months.
Time frame: 6 months
Ratio calculation (r) : r = (number of uses done) / (number of uses expected)
8 secondary outcomes
Evaluation of the use rate of the application over 6 months
Time frame: 6 months
Evaluation of the use rate of the application over 6 months
Time frame: 6 months
Evaluation of suicidal ideation after 6 months of use of the application,
Time frame: 6 months
Evaluation of suicidal recidivism at 6 months
Time frame: 6 months
Assessment of the compliance rate at recommended care
Time frame: 6 months
Assessment of the compliance rate at recommended care
Time frame: 6 months
Evaluation of the evolution of the level of sadness of the subject during the 6 months of follow-up
Time frame: 6 months
Evaluation of the evolution of the level of sleep disorders of the subject during the 6 months of follow-up
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Derived from this study: PubMed 34591030Mouchabac S, Leray P, Adrien V, Gollier-Briant F, Bonnot O. Prevention of Suicidal Relapses in Adolescents With a Smartphone Application: Bayesian Network Analysis of a Preclinical Trial Using In Silico Patient Simulations. J Med Internet Res. 2021 Sep 30;23(9):e24560. doi: 10.2196/24560.
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.
Fanny GOLLIER BRIANT study chair
Nantes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application on smartphone in people with Suicide Attempt by Scalding, run by Nantes University Hospital at 3 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 3 inclusion and 7 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 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Fanny GOLLIER BRIANT (0253482653, fanny.gollierbriant@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the usage rate of the Medical Companion application over a period of 6 months. (time frame: 6 months). 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 NCT03975881, 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 5 Jun 2019.