Electronic Mobile Phone App Stool Diary

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04644133
• Other study ID #: 1297973
• Status: Recruiting
• Start date: December 6, 2018
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2022
• Source: Augusta University
• Contact: Satish Rao, MD PhD
• Phone: (706) 446-4887
• Email: srao[@]augusta.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Fecal Incontinence
• Incontinence Bowel

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Digestive Health Clinical Research	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of electronic APP diary information with paper form stool diary in healthy subjects	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.	2 weeks each
Primary	Correlation of electronic APP diary information with paper form stool diary in fecal incontinence subjects	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	2 weeks each
Primary	The stool diary parameters	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	2 weeks each
Secondary	Stool frequency	The number of bowel movements per week (BM), the number of spontaneous bowel movements (SBM), and the number of complete spontaneous bowel movements (CSBM) will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.	2 weeks
Secondary	Stool consistency	Stool consistency (Bristol Stool scale, 1-7): 1-very hard stool, 4- normal, smooth stool, 7- watery stool, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.	2 weeks
Secondary	Bowel urgency	Severity of bowel urgency- unable to postpone BM for more than 15 minutes, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.	2 weeks
Secondary	Stool leakage	Leakage characteristics-amount: 0- none, 1-mild, 2-moderate, 3- excessive, will be compared between the APP and stool diary and between healthy subjects and patients with fecal incontinence.	2 weeks
Secondary	Complete evacuation	Feeling of complete evacuation, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.	2 weeks
Secondary	Week 1 vs Week 2 reproducibility of APP and paper diary	Compare the results for the first and the second week for the electronic APP data as well as paper data and examine the reproducibility.	1 weeks
Secondary	Straining	Stool straining will be compared between the APP and stool diary and between healthy subjects and patients with constipation.	2 weeks
Secondary	Time spent of toilet	Time spent on toilet will be compared between the APP and stool diary and between healthy subjects and patients with constipation.	2 weeks