NCT04182048Unknown不适用
Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 843
- 试验地点
- 1
- 主要终点
- Dataset completeness
研究概览
简要总结
A remote study to find out if a mobile phone application (HealthMode Stool) can serve as a useful tool to track and characterize daily bowel movements. The application provides participants with a single place to record their bowel movements either as a part of their general health self-monitoring, or because they may be dealing with a bowel movement condition. The minimal study duration is 1 month, and participants can continue using the application up to 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females and males over 18 years old
- •Willing to use their own/personal mobile phone (iPhone 6 or higher, running iOS 11 or higher) for participation
- •Willing to share demographic data with the sponsor of the study
- •Willing to follow app use instructions during the course of the study
- •Willing to log the bowel movement events on a daily basis with manual input of additional characteristics
- •Willing to complete survey instruments as described in study procedures
- •Willing to provide electronic informed consent
- •Able to read and understand the english language well enough to complete electronic informed consent
排除标准
- •New to HealthMode Stool application:
- •No additional exclusion criteria.
- •Current HealthMode Stool User:
- •Is an active participant in any other study using HealthMode Stool app in its protocol.
结局指标
主要结局
Dataset completeness
时间窗: 28 days
Aiming for 90% in two dataset completeness aspects: bowel movement entry days and bowel movement characteristics completeness.
次要结局
- Daily bowel movement characteristics and fluctuation(28 days)
- Usability of the application(28 days)
研究者
研究点 (1)
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