Multicenter Open Pilot Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Evaluate the usage rate of the Medical Companion application over a period of 6 months.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: application on smartphone (Other)
结局指标
主要结局
Evaluate the usage rate of the Medical Companion application over a period of 6 months.
时间窗: 6 months
Ratio calculation (r) : r = (number of uses done) / (number of uses expected)
次要结局
- Evaluation of suicidal recidivism at 6 months(6 months)
- Evaluation of suicidal ideation after 6 months of use of the application,(6 months)
- Evaluation of the evolution of the level of sadness of the subject during the 6 months of follow-up(6 months)
- Evaluation of the evolution of the level of sleep disorders of the subject during the 6 months of follow-up(6 months)
- Evaluation of the use rate of the application over 6 months(6 months)
- Assessment of the compliance rate at recommended care(6 months)