NCT04182048
Unknown
Not Applicable
Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- HealthMode Inc.
- Enrollment
- 843
- Locations
- 1
- Primary Endpoint
- Dataset completeness
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Dataset completeness
Time Frame: 28 days
Aiming for 90% in two dataset completeness aspects: bowel movement entry days and bowel movement characteristics completeness.
Secondary Outcomes
- Daily bowel movement characteristics and fluctuation(28 days)
- Usability of the application(28 days)
Study Sites (1)
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