Person at Risk of Suicide Clinical Trial
— EMMAOfficial title:
Development of an Algorithm and a Smartphone Application for the Evaluation and Prediction of Suicidal Risk
| Verified date | January 2021 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 97 |
| Est. completion date | June 26, 2020 |
| Est. primary completion date | June 26, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | MontpellierUniversity Hopital | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier | University Hospital Saint jacques, Besançon, University Hospital, Brest, University Hospital, Henri Mondor/Albert Chenevier, Créteil, University Hospital, Lille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurrence of a suicidal event during the follow-up | 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. | At 6 months | |
| Secondary | Evaluation of the frequency of connection of the patient to the EMMA application | The use is automatically measured by the application with the connection frequency | At 1 month | |
| Secondary | Evaluation of the frequency of connection of the patient to the EMMA application | The use is automatically measured by the application with the connection frequency | At 2 months | |
| Secondary | Evaluation of the frequency of connection of the patient to the EMMA application | The use is automatically measured by the application with the connection frequency | At 3 months | |
| Secondary | Evaluation of the frequency of connection of the patient to the EMMA application | The use is automatically measured by the application with the connection frequency | At 4 months | |
| Secondary | Evaluation of the frequency of connection of the patient to the EMMA application | The use is automatically measured by the application with the connection frequency | At 5 months | |
| Secondary | Evaluation of the frequency of connection of the patient to the EMMA application | The use is automatically measured by the application with the connection frequency | At 6 months | |
| Secondary | Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 1 month | |
| Secondary | Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 2 months | |
| Secondary | Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 3 months | |
| Secondary | Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 4 months | |
| Secondary | Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 5 months | |
| Secondary | Acceptability of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 6 months | |
| Secondary | Acceptability of EMMA assessed by the self assessment questionnaire Mobile Application Rating Scale (MARS) | At 6 months | ||
| Secondary | Acceptability of EMMA assessed by a qualitative interview | The qualitative interview is optional | At 6 months | |
| Secondary | Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 1 month | |
| Secondary | Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 2 months | |
| Secondary | Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 3 months | |
| Secondary | Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 4 months | |
| Secondary | Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 5 months | |
| Secondary | Satisfaction of EMMA assessed by the Smartphone application | Questionnaire passed with the application (Likert scales) | At 6 months | |
| Secondary | Satisfaction of EMMA assessed by the satisfaction questionnaire | At 6 months | ||
| Secondary | Satisfaction of EMMA assessed by a qualitative interview | The qualitative interview is optional | At 6 months |