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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Irritable Bowel Syndrome

• Study Type: Observational
• Enrollment (Actual): 843

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Virtual Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

US resident participants downloading the HealthMode Stool application from the Apple AppStore.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All patients

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of models for automatic determination of bowel movement characteristics	Receiver Operating Characteristic of created mathematical models	28 days

Collaborators and Investigators

• Sponsor: HealthMode Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: HM102001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No