Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations
1 other identifier
observational
843
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2019
CompletedFirst Submitted
Initial submission to the registry
November 22, 2019
CompletedFirst Posted
Study publicly available on registry
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedApril 25, 2022
April 1, 2022
2.8 years
November 22, 2019
April 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Dataset completeness
Aiming for 90% in two dataset completeness aspects: bowel movement entry days and bowel movement characteristics completeness.
28 days
Secondary Outcomes (4)
Daily bowel movement characteristics and fluctuation
28 days
Daily bowel movement characteristics and fluctuation
28 days
Daily bowel movement characteristics and fluctuation
28 days
Usability of the application
28 days
Other Outcomes (1)
Sensitivity and specificity of models for automatic determination of bowel movement characteristics
28 days
Study Arms (1)
All patients
Eligibility Criteria
US resident participants downloading the HealthMode Stool application from the Apple AppStore.
You may qualify if:
- 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
You may not qualify if:
- New to HealthMode Stool application:
- Current HealthMode Stool User:
- Is an active participant in any other study using HealthMode Stool app in its protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HealthMode Inc.lead
Study Sites (1)
Virtual Facility
The Bronx, New York, 10461, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2019
First Posted
December 2, 2019
Study Start
September 14, 2019
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
April 25, 2022
Record last verified: 2022-04