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Clinical Trials/NCT03410381
NCT03410381
Completed
Not Applicable

Development of an Algorithm and a Smartphone Application for the Evaluation and Prediction of Suicidal Risk

University Hospital, Montpellier1 site in 1 country97 target enrollmentMay 31, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Person at Risk of Suicide
Sponsor
University Hospital, Montpellier
Enrollment
97
Locations
1
Primary Endpoint
Occurrence of a suicidal event during the follow-up
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Suicide is a major health problem that causes annually a million death worldwide. Suicide and suicide attempts are preventable.

A history of self-injuries or suicidal attempts are known to be the most important risk factor for death by suicide. Suicidal ideation is also strongly correlated with suicide attempts.

The development of Smartphones applications offers new possibilities for data collection and transmission.

Moreover, the online help function, when a suicidal crisis occurs, is the most effective strategy for prevention of suicidal behavior.

Specific technologies have been developed to analyse behaviors and experiences of patients in a natural environment, in real life.

That is the goal of Ecological Momentary Assessment.

The aim of the study is to develop an algorithm to assess and predict the risk of suicidal event occurrence, in order to detect as soon as possible the signs of suicidal crisis.

EMMA will be the first application in French, meeting the recommendations for health applications, developed by experts on suicidal behavior and in collaboration with patients which aims to predict suicidal risk.

A subsequent study, conducted on a larger population, should allow to validate the predictive algorithm of EMMA.

Long-term goal is to improve the care of patients at risk for suicidal behavior.

Detailed Description

100 patients having recently attempted suicide or having suicidal ideation will be recruited. They will be asked to use the application EMMA during 6 months and will be followed up during this period. An optional qualitative study conducted on 25 patients will allow to evaluate more finely their subjective experience of the use of the application. Initial visit (inclusion) : clinical, biological and neuropsychological assessment and installation of the application EMMA. First visit (1st month) and second visit (3rd month) : clinical assessment Last visit (6th month) : clinical, biological and neuropsychological assessment and optional qualitative interview.

Registry
clinicaltrials.gov
Start Date
May 31, 2018
End Date
June 26, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Recent suicidal attempt (\< 8 days) or suicidal ideation score ≥ 2 (IDSC-30 scale)
  • More than 18 years old
  • Able to understand nature, aims, and methodology oh the study
  • To own a smartphone

Exclusion Criteria

  • Refusal to participate
  • Patient on protective measures (guardianship or trusteeship)
  • Deprived of liberty subject (administrative decision)
  • Subject in exclusion period for another protocol
  • Not affiliated to a social security agency
  • Unable to understand and/or answer a questionnaire

Outcomes

Primary Outcomes

Occurrence of a suicidal event during the follow-up

Time Frame: At 6 months

Occurrence of a suicidal event will be checked by the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire and medical records at the end of study.

Secondary Outcomes

  • Satisfaction of EMMA assessed by a qualitative interview(At 6 months)
  • Evaluation of the frequency of connection of the patient to the EMMA application(At 6 months)
  • Acceptability of EMMA assessed by the Smartphone application(At 6 months)
  • Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS)(At 6 months)
  • Satisfaction of EMMA assessed by the satisfaction questionnaire(At 6 months)
  • Acceptability of EMMA assessed by a qualitative interview(At 6 months)
  • Satisfaction of EMMA assessed by the Smartphone application(At 6 months)

Study Sites (1)

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