Recruiting

Observational Study

Sponsor:

Augusta University

Code:

NCT04644133

Conditions

Constipation

Incontinence Bowel

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paper diary

Electronic APP diary

Study Details

Brief summary:

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.

Conditions

Constipation

Incontinence Bowel

Study ID

NCT04644133

Start date

Dec 6, 2018

Status verified date

Jul, 2022

Completion date

Mar 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

135 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Paper diary

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

Electronic APP diary

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

Primary outcome measure

  • Correlation of electronic APP diary information with paper form stool diary in healthy subjects [ Time Frame: 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 [ Time Frame: 2 weeks each ]

Central Contacts and Locations

Central contacts

Satish Rao, MD PhD

(706) 446-4887srao@augusta.edu

Amol Sharma, MD

70672122amosharma@augusta.edu

Locations

Digestive Health Clinical Research

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Satish Rao, MD PhD

706-446-4887srao@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Jul 21, 2022

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2022-07-21.