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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04182048
• Other study ID #: HM102001
• Status: Active, not recruiting
• Start date: September 14, 2019
• Est. completion date: July 2022

Study information

• Verified date: April 2022
• Source: HealthMode Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 843
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Irritable Bowel Syndrome

Locations

Country	Name	City	State
United States	Virtual Facility	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
HealthMode Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensitivity and specificity of models for automatic determination of bowel movement characteristics	Receiver Operating Characteristic of created mathematical models	28 days
Primary	Dataset completeness	Aiming for 90% in two dataset completeness aspects: bowel movement entry days and bowel movement characteristics completeness.	28 days
Secondary	Daily bowel movement characteristics and fluctuation	Measured as category frequency and fluctuations in Bristol Stool Scale items	28 days
Secondary	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
Secondary	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
Secondary	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