Smart Phone App for COLOnoscopic PREParation

Not Applicable

Completed

• Conditions: Colorectal Cancer Screening; Colonoscopy; Mass Screening
• Interventions: Other: Bowel Preparation

• Registration Number: NCT03225560
• Lead Sponsor: Sunil Patel

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.

Study Timeline

• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Study Start: 2018-11-21
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Paper Instructions	Bowel Preparation	Traditional paper instructions for bowel preparation
Smart Phone Application	Bowel Preparation	A novel smart phone application available for both Apple iOS and Google Android platforms with capabilities to populate the phone calendar with automated reminders/notifications at the appropriate times prior to the colonoscopy.

Primary Outcome Measures

Name	Time	Method
Quality of Bowel Preparation	At time of colonoscopy	The quality of bowel preparation as assessed by the validated Boston and Aronchick bowel preparation scales

Secondary Outcome Measures

Name	Time	Method
Patient reported adherence to bowel preparation instructions	At time of colonoscopy	Patient questionnaire used to determine the adherence to the pre-specified bowel preparation instructions.
Adenomatous polyp detection	At time of colonoscopy	The number of adenomatous polyps detected
Cecal Intubation	At time of colonoscopy	The ability for the colonoscopist to intubate the cecum

Trial Locations

Locations (1)

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada