Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations

• Conditions: Healthy; Irritable Bowel Syndrome

• Registration Number: NCT04182048
• Lead Sponsor: HealthMode Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-14
• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-12-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 843

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.

OR

• Current HealthMode Stool User:
• Is an active participant in any other study using HealthMode Stool app in its protocol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dataset completeness	28 days	Aiming for 90% in two dataset completeness aspects: bowel movement entry days and bowel movement characteristics completeness.

Secondary Outcome Measures

Name	Time	Method
Daily bowel movement characteristics and fluctuation	28 days	Measured as changes in Visceral Sensitivity Index score. The score ranges from 15 to 90, lower score indicating a worse outcome
Usability of the application	28 days	Level of usability of the solution by patients by means of a Standard Usability Questionnaire score. The score ranges from 10 to 50, higher score indicating a better usability.

Trial Locations

Locations (1)

Virtual Facility; 🇺🇸 Bronx, New York, United States