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Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted (MED COMPANION)

Primary Purpose

Suicide Attempt by Scalding

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
application on smartphone
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide Attempt by Scalding focused on measuring Suicide attempts, digital device, adolescent, adults

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU d'Angers
  • CH Poitiers
  • CH Rennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm 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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Evaluation of the use rate of the application over 6 months
duration of use of the application
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)
Evaluation of suicidal recidivism at 6 months
Rate of suicidal recidivism at 6 months evaluated by phone call in families
Assessment of the compliance rate at recommended care
Rate of compliance to recommended care at discharge from hospital (number of appointments honored)
Assessment of the compliance rate at recommended care
Rate of compliance to recommended care at 6 months evaluated by phone call in families
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
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.

Full Information

First Posted
April 9, 2018
Last Updated
June 4, 2019
Sponsor
Nantes University Hospital
Collaborators
University Hospital, Angers, Rennes University Hospital, Saint Antoine University Hospital, Université de Nantes, Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03975881
Brief Title
Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted
Acronym
MED COMPANION
Official Title
Multicenter Open Pilot Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
University Hospital, Angers, Rennes University Hospital, Saint Antoine University Hospital, Université de Nantes, Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Attempt by Scalding
Keywords
Suicide attempts, digital device, adolescent, adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
application on smartphone
Other Intervention Name(s)
MEDICAL COMPANION
Intervention Description
The aim of this study is to test the feasibility of our approach of preventing suicide relapse with the use of a smartphone application.
Primary Outcome Measure Information:
Title
Evaluate the usage rate of the Medical Companion application over a period of 6 months.
Description
Ratio calculation (r) : r = (number of uses done) / (number of uses expected)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluation of the use rate of the application over 6 months
Description
Frequency of use of the application, data generated automatically by the internal program of the application Medical Companion
Time Frame
6 months
Title
Evaluation of the use rate of the application over 6 months
Description
duration of use of the application
Time Frame
6 months
Title
Evaluation of suicidal ideation after 6 months of use of the application,
Description
Rate of suicidal ideation at 6 months assessed by telephone call in families using ( 1 to 7)
Time Frame
6 months
Title
Evaluation of suicidal recidivism at 6 months
Description
Rate of suicidal recidivism at 6 months evaluated by phone call in families
Time Frame
6 months
Title
Assessment of the compliance rate at recommended care
Description
Rate of compliance to recommended care at discharge from hospital (number of appointments honored)
Time Frame
6 months
Title
Assessment of the compliance rate at recommended care
Description
Rate of compliance to recommended care at 6 months evaluated by phone call in families
Time Frame
6 months
Title
Evaluation of the evolution of the level of sadness of the subject during the 6 months of follow-up
Description
Visual Analogic scale (1 is bad to 10 is perfect ) generated automatically from the subject's responses by the application's internal program
Time Frame
6 months
Title
Evaluation of the evolution of the level of sleep disorders of the subject during the 6 months of follow-up
Description
Visual Analogic scale (1 is bad to 10 is perfect ) generated automatically from the subject's responses by the application's internal program.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fanny GOLLIER BRIANT
Phone
0253482653
Email
fanny.gollierbriant@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier BONNOT
Phone
0253482653
Email
olivier.bonnot@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanny GOLLIER BRIANT
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
CHU d'Angers
City
Angers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénédicte GOHIER
Email
BeGoohier@chu-anger.fr
Facility Name
CH Poitiers
City
Poitiers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludovic Gicquel
Email
ludovic.gicquel@ch-poitiers.fr
Facility Name
CH Rennes
City
Rennes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Drapier
Email
d.drapier@ch-guillaumerenier.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
34591030
Citation
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.
Results Reference
derived

Learn more about this trial

Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted

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