Assessment of Daily Electronic Stool Diary for Constipation and Fecal Incontinence.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Constipation
- Sponsor
- Augusta University
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Correlation of electronic APP diary information with paper form stool diary in healthy subjects
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Satish Rao
Professor
Augusta University
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
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.
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
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
Secondary Outcomes
- Stool frequency(2 weeks)
- Stool leakage(2 weeks)
- Bowel urgency(2 weeks)
- Time spent of toilet(2 weeks)
- Stool consistency(2 weeks)
- Complete evacuation(2 weeks)
- Week 1 vs Week 2 reproducibility of APP and paper diary(1 weeks)
- Straining(2 weeks)