Irritable Bowel SyndromeNCT04182048
Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations
An observational study of Irritable Bowel Syndrome and Healthy, run by HealthMode Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Healthy
- How many people
- 843 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2019to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: US resident participants downloading the HealthMode Stool application from the Apple AppStore.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Irritable Bowel Syndrome, Healthy
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dataset completeness
Aiming for 90% in two dataset completeness aspects: bowel movement entry days and bowel movement characteristics completeness.
Measured: 28 days
Secondary outcomes (4)
Daily bowel movement characteristics and fluctuation
Measured as category frequency and fluctuations in Bristol Stool Scale items
Measured: 28 days
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
Measured: 28 days
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
Measured: 28 days
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start14 Sep 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthMode Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182048
- Sponsor's protocol ID
- HM102001
- Status last verified
- Apr 2022
- First submitted
- 22 Nov 2019
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations
- ClinicalTrials.gov ID
- NCT04182048
- Acronym / sponsor ID
- HM102001
- Conditions
- Irritable Bowel Syndrome, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 843 participants (actual)
- Lead sponsor
- HealthMode Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- US resident participants downloading the HealthMode Stool application from the Apple AppStore.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dataset completeness
Time frame: 28 days
Aiming for 90% in two dataset completeness aspects: bowel movement entry days and bowel movement characteristics completeness.
4 secondary outcomes
Daily bowel movement characteristics and fluctuation
Time frame: 28 days
Daily bowel movement characteristics and fluctuation
Time frame: 28 days
Daily bowel movement characteristics and fluctuation
Time frame: 28 days
Usability of the application
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome and Healthy, run by HealthMode Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dataset completeness (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.