Remote Study of an Electronic Means to Characterize Bowel... | NCT04182048

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

NCT04182048

Sponsor

HealthMode Inc.

Status

Unknown status

Last Update Posted

Apr 25, 2022Actual

Enrollment

843Actual

Phase

Not provided

Conditions

Irritable Bowel Syndrome
Healthy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2019Actual

Primary Completion Date

Jul 2022Estimated

Completion Date

Jul 2022Estimated

First Submitted Date

Nov 22, 2019

First Submission Date that Met QC Criteria

Nov 26, 2019

First Posted Date

Dec 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2022

Last Update Posted Date

Apr 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

843Actual

Label	Type	Description	Intervention Names
All patients

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Current HealthMode Stool User:
Is an active participant in any other study using HealthMode Stool app in its protocol.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Virtual Facility		The Bronx	New York	10461	United States

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided