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Clinical Trials/NCT04182048
NCT04182048
Unknown
Not Applicable

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

HealthMode Inc.1 site in 1 country843 target enrollmentSeptember 14, 2019

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.

Registry
clinicaltrials.gov
Start Date
September 14, 2019
End Date
July 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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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