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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04182048

Enrollment

843

Registered

2019-12-02

Start date

2019-09-14

Completion date

2022-07-31

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Irritable Bowel Syndrome

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Daily bowel movement characteristics and fluctuation	28 days	Measured as category frequency and fluctuations in Bristol Stool Scale items
Usability of the application	28 days	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.

Other

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

Countries

United States

Outcome results