Clinical trial NCT04644133: Electronic Mobile Phone App Stool Diary
Official title: Assessment of Daily Electronic Stool Diary for Constipation and Fecal Incontinence.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Constipation
Incontinence Bowel
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone symptoms of Fecal Incontinence (FI), Constipation, or Healthy (i.e. no bowel issues).

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.

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:

* None

Primary outcomes:
measure: Correlation of electronic APP diary information with paper form stool diary in healthy subjects
timeFrame: 2 weeks each
measure: Correlation of electronic APP diary information with paper form stool diary in fecal incontinence subjects
timeFrame: 2 weeks each
measure: The stool diary parameters
timeFrame: 2 weeks each
Secondary outcomes:
measure: Stool frequency
timeFrame: 2 weeks
measure: Stool consistency
timeFrame: 2 weeks
measure: Bowel urgency
timeFrame: 2 weeks
measure: Stool leakage
timeFrame: 2 weeks
measure: Complete evacuation
timeFrame: 2 weeks
measure: Week 1 vs Week 2 reproducibility of APP and paper diary
timeFrame: 1 weeks
measure: Straining
timeFrame: 2 weeks
measure: Time spent of toilet
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Digestive Health Clinical Research
state: Georgia
Study officials:
affiliation: Augusta University
name: Satish Rao, MD PhD
role: STUDY_DIRECTOR
References: