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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)

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ClinicalTrials.gov Identifier: NCT03975881
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
University Hospital, Angers
Rennes University Hospital
Saint Antoine University Hospital
Université de Nantes
Poitiers University Hospital
Information provided by (Responsible Party):
Nantes University Hospital

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).


Condition or disease Intervention/treatment Phase
Suicide Attempt by Scalding Other: application on smartphone Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Multicenter Open Pilot Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Open Label
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).
Other: application on smartphone
The aim of this study is to test the feasibility of our approach of preventing suicide relapse with the use of a smartphone application.
Other Name: MEDICAL COMPANION




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Evaluation of the use rate of the application over 6 months [ Time Frame: 6 months ]
    Frequency of use of the application, data generated automatically by the internal program of the application Medical Companion

  2. Evaluation of the use rate of the application over 6 months [ Time Frame: 6 months ]
    duration of use of the application

  3. Evaluation of suicidal ideation after 6 months of use of the application, [ Time Frame: 6 months ]
    Rate of suicidal ideation at 6 months assessed by telephone call in families using ( 1 to 7)

  4. Evaluation of suicidal recidivism at 6 months [ Time Frame: 6 months ]
    Rate of suicidal recidivism at 6 months evaluated by phone call in families

  5. Assessment of the compliance rate at recommended care [ Time Frame: 6 months ]
    Rate of compliance to recommended care at discharge from hospital (number of appointments honored)

  6. Assessment of the compliance rate at recommended care [ Time Frame: 6 months ]
    Rate of compliance to recommended care at 6 months evaluated by phone call in families

  7. Evaluation of the evolution of the level of sadness of the subject during the 6 months of follow-up [ Time Frame: 6 months ]
    Visual Analogic scale (1 is bad to 10 is perfect ) generated automatically from the subject's responses by the application's internal program

  8. Evaluation of the evolution of the level of sleep disorders of the subject during the 6 months of follow-up [ Time Frame: 6 months ]
    Visual Analogic scale (1 is bad to 10 is perfect ) generated automatically from the subject's responses by the application's internal program.



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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975881


Contacts
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Contact: Fanny GOLLIER BRIANT 0253482653 fanny.gollierbriant@chu-nantes.fr
Contact: Olivier BONNOT 0253482653 olivier.bonnot@chu-nantes.fr

Locations
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France
CHU d'Angers Not yet recruiting
Angers, France
Contact: Bénédicte GOHIER       BeGoohier@chu-anger.fr   
CH Poitiers Not yet recruiting
Poitiers, France
Contact: Ludovic Gicquel       ludovic.gicquel@ch-poitiers.fr   
CH Rennes Not yet recruiting
Rennes, France
Contact: Dominique Drapier       d.drapier@ch-guillaumerenier.fr   
Sponsors and Collaborators
Nantes University Hospital
University Hospital, Angers
Rennes University Hospital
Saint Antoine University Hospital
Université de Nantes
Poitiers University Hospital
Investigators
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Study Chair: Fanny GOLLIER BRIANT Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03975881     History of Changes
Other Study ID Numbers: RC18_0038
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
Suicide attempts
digital device
adolescent
adults

Additional relevant MeSH terms:
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Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms