Smart Phone App for COLOnoscopic PREParation

NCT ID: NCT03225560

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2023-01-30

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.

Conditions

Colorectal Cancer Screening; Colonoscopy; Mass Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Smart Phone Application

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.

Group Type: EXPERIMENTAL

Bowel Preparation

Intervention Type: OTHER

Bowel Preparation is completed prior to colonoscopy to ensure adequate visualization of the bowel lumen. This requires diet modifications and taking of medications at specified time intervals.

Traditional Paper Instructions

Traditional paper instructions for bowel preparation

Group Type: ACTIVE_COMPARATOR

Bowel Preparation

Intervention Type: OTHER

Bowel Preparation is completed prior to colonoscopy to ensure adequate visualization of the bowel lumen. This requires diet modifications and taking of medications at specified time intervals.

Interventions

Bowel Preparation

Bowel Preparation is completed prior to colonoscopy to ensure adequate visualization of the bowel lumen. This requires diet modifications and taking of medications at specified time intervals.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunil Patel

OTHER

Sponsor Role: lead

Responsible Party

Sunil Patel

Assistant Professor and Attending Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sunil V Patel, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

6020364

Identifier Type: -

Identifier Source: org_study_id