A Clinical Trial to Study the Benefit of a Mobile App to Guide Patients Preparing for Colonoscopy in Comparison to Usual Instructional Handouts.

Phase 2

Suspended

Conditions: Diseases of the digestive system,

Registration Number: CTRI/2019/08/020732

Lead Sponsor: Dr Rohit D

Brief Summary: This clinical trial is a single-center, single-blind, prospective, randomized, controlled, pilot study comparing the efficacy of a smartphone app and verbal/written patient instructions to evaluate the impact of a mobile software application in reducing the failure rate of outpatient colonoscopy by improving the quality of bowel preparation through enhanced patient adherence. The target sample size is 20 patients. The primary outcome measure will be the percentage of patients with Ottawa Bowel Preparation Quality Scale Score less than 8 during the colonoscopy procedure. The secondary outcome measures will be the overall improvement in adherence according to a specially developed Adherence Score and degree of patient satisfaction with the smartphone app for bowel preparation compared to the standard method of care.

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: All

Target Recruitment: 20

Inclusion Criteria

Outpatient, elective, screening colonoscopy; Age from 20 to 50 years; Having their first colonoscopy; Owning an Android-based smartphone with or without always-on internet connection; Having the ability to download and configure regimen personalization settings and skillfully use the app; Having the ability to read and understand English or Kannada or Malayalam very well; Having and using western-style toilet bowl in their home; Written informed consent.

Exclusion Criteria

Patients with severe comorbidities (congestive heart failure, chronic renal disease, ascites, etc.); History of prior colonoscopies (experience in bowel preparation); Patients taking iron supplements; History of chronic drug use (constipation drugs, laxatives, or anti-diarrheal agents); Pregnancy or lactation; Known inflammatory bowel disease; Presence of psychotic or major mental illness or intellectual faculties insufficient to use a smartphone app; Known or suspected poor compliance; Allergy to the purgative solution; History of colorectal surgery; Patients with planned endoscopic therapy;.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with Ottawa Bowel Preparation Quality Scale Score less than 8.	At the time of colonoscopy.

Secondary Outcome Measures

Name	Time	Method
Overall improvement in adherence according to a specially developed Adherence Score.	At the time of patient colonoscopy visit.
Degree of patient satisfaction with the smartphone app for bowel preparation compared to the standard method of care.	At the time of patient colonoscopy visit.

Trial Locations

Locations (1): Kasturba Medical College Hospital Manipal
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College Hospital Manipal
🇮🇳Udupi, KARNATAKA, India
Dr Rohit D
Principal investigator
9113644268
rohitdigital@icloud.com