Electronic Mobile Phone App Stool Diary

NCT04644133 | Unknown

• 1 other identifier: 1297973
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (8)

• Stool frequency

  2 weeks

• Stool consistency

  2 weeks

• Bowel urgency

  2 weeks

• Stool leakage

  2 weeks

• Complete evacuation

  2 weeks

Study Arms (3)

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.

Other: Paper diary; Other: Electronic APP diary

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.

Other: Paper diary; Other: Electronic APP diary

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.

Other: Paper diary; Other: Electronic APP diary

Interventions

Paper diary OTHER

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

Constipation; Fecal Incontinence; Healthy

Electronic APP diary OTHER

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

Constipation; Fecal Incontinence; Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anyone symptoms of Fecal Incontinence (FI), Constipation, or Healthy (i.e. no bowel issues).

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Digestive Health Clinical Research

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Constipation; Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Satish Rao, MD PhD

  Augusta University

  STUDY DIRECTOR

Central Study Contacts

Satish Rao, MD PhD

CONTACT

(706) 446-4887; srao@augusta.edu

Amol Sharma, MD

CONTACT

70672122; amosharma@augusta.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: November 25, 2020
• Study Start: December 6, 2018
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

US (1)