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

Study Overview
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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.

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

Conditions
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Irritable Bowel Syndrome, Healthy

Participation Criteria
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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: No additional exclusion criteria. OR Current HealthMode Stool User: Is an active participant in any other study using HealthMode Stool app in its protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dataset completeness | Aiming for 90% in two dataset completeness aspects: bowel movement entry days and bowel movement characteristics completeness. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily bowel movement characteristics and fluctuation | Measured as category frequency and fluctuations in Bristol Stool Scale items | 28 days | 
| Daily bowel movement characteristics and fluctuation | Measured as changes in Gastro-intestinal Symptom Rating Scale score. The score ranges from 15 to 105, lower score indicating a better outcome | 28 days | 
| Daily bowel movement characteristics and fluctuation | Measured as changes in Visceral Sensitivity Index score. The score ranges from 15 to 90, lower score indicating a worse outcome | 28 days | 
| Usability of the application | 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. | 28 days |