Electronic Mobile Phone App Stool Diary

NCT ID: NCT04644133

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-06

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Constipation Incontinence Bowel

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Paper diary

Intervention Type OTHER

Subjects will be asked to complete a 2 week paper stool diary.

Electronic APP diary

Intervention Type OTHER

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.

Paper diary

Intervention Type OTHER

Subjects will be asked to complete a 2 week paper stool diary.

Electronic APP diary

Intervention Type OTHER

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.

Paper diary

Intervention Type OTHER

Subjects will be asked to complete a 2 week paper stool diary.

Electronic APP diary

Intervention Type OTHER

Subjects will be asked to complete a 2 week paper stool diary.

Interventions

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Paper diary

Subjects will be asked to complete a 2 week paper stool diary.

Intervention Type OTHER

Electronic APP diary

Subjects will be asked to complete a 2 week paper stool diary.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Satish Rao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Satish Rao, MD PhD

Role: STUDY_DIRECTOR

Augusta University

Locations

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Digestive Health Clinical Research

Augusta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Satish Rao, MD PhD

Role: CONTACT

(706) 446-4887

Amol Sharma, MD

Role: CONTACT

Facility Contacts

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Satish Rao, MD PhD

Role: primary

706-446-4887

Other Identifiers

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1297973

Identifier Type: -

Identifier Source: org_study_id

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