Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder
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
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Graz、奥地利、8010
- Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Rejection of participation
- Lack of knowledge about how to deal with a smartphone
- Congenital / early-childhood intelligence reduction
- Moderate / severe dementia
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：People With a Bipolar Affective Disorder
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Participants use the BiP-App for 6 months.
The app continuously records data on light and motion sensors, as well as Global Positioning System (GPS) and mood surveys.
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有源比较器：Control subjects without a psychiatric disorder
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Participants use the BiP-App for 6 months.
The app continuously records data on light and motion sensors, as well as Global Positioning System (GPS) and mood surveys.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sleep duration
大体时间：6 months
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in minutes
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6 months
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Movement behaviour
大体时间：6 months
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evaluated through motion sensors and localization services
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6 months
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Mood
大体时间：6 months
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evaluated by mood surveys
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6 months
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Communication behaviour
大体时间：6 months
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Frequency of usage of communication services
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient acceptance
大体时间：6 months
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evaluated by a questionnaire
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6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.