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

HealthMode

Status: Unknown

Conditions: Irritable Bowel Syndrome; Healthy

Study type: Observational

Funder types: Industry

Identifiers

NCT04182048

HM102001

Details and patient eligibility

About

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.

Enrollment: 843 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

843 participants in 1 patient group

All patients