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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04182048
Recruitment Status : Active, not recruiting
First Posted : December 2, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
HealthMode Inc.

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.

Condition or disease
Irritable Bowel Syndrome Healthy

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Study Type : Observational
Actual Enrollment : 569 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations
Actual Study Start Date : September 14, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort
All patients



Primary Outcome Measures :
  1. Dataset completeness [ Time Frame: 28 days ]
    Aiming for 90% in two dataset completeness aspects: bowel movement entry days and bowel movement characteristics completeness.


Secondary Outcome Measures :
  1. Daily bowel movement characteristics and fluctuation [ Time Frame: 28 days ]
    Measured as category frequency and fluctuations in Bristol Stool Scale items

  2. Daily bowel movement characteristics and fluctuation [ Time Frame: 28 days ]
    Measured as changes in Gastro-intestinal Symptom Rating Scale score. The score ranges from 15 to 105, lower score indicating a better outcome

  3. Daily bowel movement characteristics and fluctuation [ Time Frame: 28 days ]
    Measured as changes in Visceral Sensitivity Index score. The score ranges from 15 to 90, lower score indicating a worse outcome

  4. Usability of the application [ Time Frame: 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 Outcome Measures:
  1. Sensitivity and specificity of models for automatic determination of bowel movement characteristics [ Time Frame: 28 days ]
    Receiver Operating Characteristic of created mathematical models



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
US resident participants downloading the HealthMode Stool application from the Apple AppStore.
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.

OR

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182048


Locations
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United States, New York
Virtual Facility
Bronx, New York, United States, 10461
Sponsors and Collaborators
HealthMode Inc.
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Responsible Party: HealthMode Inc.
ClinicalTrials.gov Identifier: NCT04182048    
Other Study ID Numbers: HM102001
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases