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Clinical Trials/NCT03225560
NCT03225560
Completed
N/A

A Novel Smart Phone Application for Patients Undergoing COLOnoscopic Bowel PREParation: A Randomized Controlled Trial

Sunil Patel1 site in 1 country238 target enrollmentNovember 21, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Colorectal Cancer Screening
Sponsor
Sunil Patel
Enrollment
238
Locations
1
Primary Endpoint
Quality of Bowel Preparation
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This is a randomized controlled trial designed to assess the efficacy of a novel smartphone application as an automated reminder tool in improving the quality of bowel preparation for patients undergoing outpatient colonoscopies. The investigators will be comparing the smartphone application to traditional instructions for bowel preparation. The quality of bowel preparation will be assessed using the Ottawa and Aronchick bowel preparation scales.

Detailed Description

This is a randomized controlled trial designed to assess the efficacy of a novel smartphone application as an automated reminder tool in improving the quality of bowel preparation for patients undergoing outpatient colonoscopies at an academic teaching hospital in Kingston, Ontario. The intervention under investigation is the use of a novel smart phone application which serves as an automated reminder system for patients undergoing outpatient colonoscopies. The application requires the patients to enter the date and time of the colonoscopy appointment and automatically populates the patients' phones with calendar reminders as well as pre-recorded messages regarding cessation of solid food intake, the need for clear fluid intake, as well as timing of their bowel regimens starting 7 days prior. The design of this study is a prospective, randomized controlled trial with single blinding (endoscopist). Eligible participants will be randomized into either the control (routine paper instructions) or the intervention group (smart phone application). Those who are randomized into the intervention group will be provided with specific instructions to download and setup the smart phone application at least 7 days prior to their scheduled appointment. Upon arrival to their appointment, participants in both groups will be asked to complete a survey confirming the adherence to either paper instructions or instructions provided by the smart phone application. The primary outcome of this study is the adequacy of the bowel preparation, as assessed by using the Ottawa and Aronchick bowel preparation scales, which have been previously validated and are in common usage for colonoscopy procedures. Secondary outcomes include rate of polyp detection, rate of cecal intubation, and patient reported ease of use and adherence to the bowel regimen instructions.

Registry
clinicaltrials.gov
Start Date
November 21, 2018
End Date
January 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sunil Patel
Responsible Party
Sponsor Investigator
Principal Investigator

Sunil Patel

Assistant Professor and Attending Surgeon

Queen's University

Eligibility Criteria

Inclusion Criteria

  • Access to smart phone with the ability to download smart phone application
  • Outpatient screening colonoscopy

Exclusion Criteria

  • Patient refusal
  • Bowel preparation other than pico-salax or GoLytely
  • Urgent/Emergent Colonoscopy
  • Patient requiring combined upper and lower endoscopic evaluation
  • No access to smart phone or inability to download smart phone application
  • Surveillance colonoscopy for previously resected cancer
  • Inflammatory bowel disease

Outcomes

Primary Outcomes

Quality of Bowel Preparation

Time Frame: At time of colonoscopy

The quality of bowel preparation as assessed by the validated Boston and Aronchick bowel preparation scales

Secondary Outcomes

  • Patient reported adherence to bowel preparation instructions(At time of colonoscopy)
  • Adenomatous polyp detection(At time of colonoscopy)
  • Cecal Intubation(At time of colonoscopy)

Study Sites (1)

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