Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Mood
研究概览
简要总结
The primary objective of the clinical trial is to evaluate the data of an app for smartphones (BiP-App) with regard to sleep, movement, mood and communication behavior.
The data will be compared between two groups: people with a bipolar affective disorder and individuals without a psychiatric disorder.
Secondary objective of the trial is to investigate if it is possible to detect early warning symptoms of depressive / (hypo) manic episodes via the measured behavior patterns.
Furthermore it will be evaluated whether the BiP-app can find applicability in the examined patient group.
Study design: Clinical evaluation of a medical device without CE mark; Parallel study design
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written consent of the participant after clarification
- •Patients with a bipolar affective disorder (group of patients) Or control persons without a mental illness (control group)
- •Age between 18 and 70 years
- •Knowledge about using a smartphone
排除标准
- •Rejection of participation
- •Lack of knowledge about how to deal with a smartphone
- •Congenital / early-childhood intelligence reduction
- •Moderate / severe dementia
结局指标
主要结局
Mood
时间窗: 6 months
evaluated by mood surveys
Sleep duration
时间窗: 6 months
in minutes
Movement behaviour
时间窗: 6 months
evaluated through motion sensors and localization services
Communication behaviour
时间窗: 6 months
Frequency of usage of communication services
次要结局
- Patient acceptance(6 months)