Development of an Algorithm and a Smartphone Application for the Evaluation and Prediction of Suicidal Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Occurrence of a suicidal event during the follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Occurrence of a suicidal event during the follow-up
时间窗: 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.
次要结局
- 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)