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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

843 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-14

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

No interventions assigned to this group

Eligibility Criteria

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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:

OR

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes