Smart Phone App for COLOnoscopic PREParation

Colonoscopy Clinical Trial

— COLOPREP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225560
• Other study ID #: 6020364
• Status: Completed
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: January 30, 2023

Study information

• Verified date: November 2023
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: January 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy
• Colorectal Cancer Screening
• Colorectal Neoplasms
• Mass Screening

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunil Patel

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Bowel Preparation	The quality of bowel preparation as assessed by the validated Boston and Aronchick bowel preparation scales	At time of colonoscopy
Secondary	Cecal Intubation	The ability for the colonoscopist to intubate the cecum	At time of colonoscopy
Secondary	Adenomatous polyp detection	The number of adenomatous polyps detected	At time of colonoscopy
Secondary	Patient reported adherence to bowel preparation instructions	Patient questionnaire used to determine the adherence to the pre-specified bowel preparation instructions.	At time of colonoscopy