Electronic Mobile Phone App Stool Diary

July 19, 2022 updated by: Satish Rao, Augusta University

Assessment of Daily Electronic Stool Diary for Constipation and Fecal Incontinence.

Our objective here is to improve the patient's compliance and accurate capture of patient reported bowel and abdominal symptoms, by utilizing a phone application that interactively records each bowel movement or leakage event and other bowel symptoms. Such an electronic stool diary may relieve the burden of using a paper daily stool diary. We will compare and validate the electronic stool diary with the paper stool diary.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Fecal incontinence consists of multiple and often unpredictable bowel movements and leakage of stool. Chronic constipation is associated with episodes of irregular and unpredictable bowel habits and difficulty with remembering symptoms. These features lead to a recall bias, and inaccurate recollection and/or documentation of symptoms that are critical for diagnosis and management. A daily stool diary has been used in clinical trials and in clinical practice to accurately record bowel symptoms. However, patients find these diary entries cumbersome or embarrassing to use, especially with bowel movements that occur outside of home resulting in loss of data or inaccurate collection of information. Also, many patients forget events especially when this bowel habit is irregular. Therefore, it is crucial to explore new ways of accurately, reliability, and more discretely collect bowel habit information, by using current technology that a majority of people have access to.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Digestive Health Clinical Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Anyone symptoms of Fecal Incontinence (FI), Constipation, or Healthy (i.e. no bowel issues).

Description

Inclusion Criteria:

  • Anyone older than 18 years with symptoms of Fecal Incontinence (FI), Constipation, or Healthy (i.e. no bowel issues).
  • Women of childbearing age will be asked if they are pregnant, and a confirmed negative response is given will be sufficient. No pregnancy test will be performed.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy
Subjects without bowel issues will be asked to complete a 2 week electronic stool diary and a 2 week paper stool diary. They will complete feedback questionnaires for comparison between the two forms of diaries. The subjects will have the option to download the Stool Dairy App or if they do not have access to a smartphone they will be provided with a phone on which one the app has already been uploaded and instructed on its use. Subject's charts may be reviewed.
Other: Paper diary
Subjects will be asked to complete a 2 week paper stool diary.
Other: Electronic APP diary
Subjects will be asked to complete a 2 week paper stool diary.
Constipation
Subjects diagnosed with constipation will be asked to complete a 2 week electronic stool diary and a 2 week paper stool diary. They will complete feedback questionnaires for comparison between the two forms of diaries. The subjects will have the option to download the Stool Dairy App or if they do not have access to a smartphone they will be provided with a phone on which one the app has already been uploaded and instructed on its use. Subject's charts may be reviewed.
Other: Paper diary
Subjects will be asked to complete a 2 week paper stool diary.
Other: Electronic APP diary
Subjects will be asked to complete a 2 week paper stool diary.
Fecal Incontinence
Subjects diagnosed with fecal incontinence will be asked to complete a 2 week electronic stool diary and a 2 week paper stool diary. They will complete feedback questionnaires for comparison between the two forms of diaries. The subjects will have the option to download the Stool Dairy App or if they do not have access to a smartphone they will be provided with a phone on which one the app has already been uploaded and instructed on its use. Subject's charts may be reviewed.
Other: Paper diary
Subjects will be asked to complete a 2 week paper stool diary.
Other: Electronic APP diary
Subjects will be asked to complete a 2 week paper stool diary.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation of electronic APP diary information with paper form stool diary in healthy subjects
Time Frame: 2 weeks each
The stool diary parameters: number of bowel movements, number of leakages, stool consistency, urgency, time spent on toilet, feeling of incomplete evacuation,straining, gas and bloating recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in healthy subjects.
2 weeks each
Correlation of electronic APP diary information with paper form stool diary in fecal incontinence subjects
Time Frame: 2 weeks each
The stool diary parameters; number of bowel movements, number of leakages, stool consistency, urgency, sensation before leakage, feeling of incomplete evacuation,use of pads and medication use recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in fecal incontinence subjects
2 weeks each
The stool diary parameters
Time Frame: 2 weeks each
The stool diary parameters: number of bowel movements, stool consistency, urgency, time spent on toilet, feeling of incomplete evacuation,straining, gas and bloating recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in constipation subjects
2 weeks each

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stool frequency
Time Frame: 2 weeks
The number of bowel movements per week (BM), the number of spontaneous bowel movements (SBM), and the number of complete spontaneous bowel movements (CSBM) will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
2 weeks
Stool consistency
Time Frame: 2 weeks
Stool consistency (Bristol Stool scale, 1-7): 1-very hard stool, 4- normal, smooth stool, 7- watery stool, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
2 weeks
Bowel urgency
Time Frame: 2 weeks
Severity of bowel urgency- unable to postpone BM for more than 15 minutes, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
2 weeks
Stool leakage
Time Frame: 2 weeks
Leakage characteristics-amount: 0- none, 1-mild, 2-moderate, 3- excessive, will be compared between the APP and stool diary and between healthy subjects and patients with fecal incontinence.
2 weeks
Complete evacuation
Time Frame: 2 weeks
Feeling of complete evacuation, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
2 weeks
Week 1 vs Week 2 reproducibility of APP and paper diary
Time Frame: 1 weeks
Compare the results for the first and the second week for the electronic APP data as well as paper data and examine the reproducibility.
1 weeks
Straining
Time Frame: 2 weeks
Stool straining will be compared between the APP and stool diary and between healthy subjects and patients with constipation.
2 weeks
Time spent of toilet
Time Frame: 2 weeks
Time spent on toilet will be compared between the APP and stool diary and between healthy subjects and patients with constipation.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Augusta University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Satish Rao, MD PhD, Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1297973

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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