NCT04644133

Electronic Mobile Phone App Stool Diary

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 135 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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.

Conditions

• Constipation
• Incontinence Bowel

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-12-06
• Primary completion: 2023-12-31
• Completion: 2024-03-31
• First posted: 2020-11-25
• Last updated: 2022-07-21

Locations

1 site across 1 country: United States