Smart Phone App for COLOnoscopic PREParation

NCT03225560 | Completed

• 1 other identifier: 6020364
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Screening; Colonoscopy; Mass Screening

Keywords

Smart Phone Application; Bowel Preparation; Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cecal Intubation

  At time of colonoscopy

• Adenomatous polyp detection

  At time of colonoscopy

• Patient reported adherence to bowel preparation instructions

  At time of colonoscopy

Study Arms (2)

Smart Phone Application

EXPERIMENTAL

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.

Other: Bowel Preparation

Traditional Paper Instructions

ACTIVE COMPARATOR

Traditional paper instructions for bowel preparation

Other: Bowel Preparation

Interventions

Bowel Preparation 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.

Smart Phone Application; Traditional Paper Instructions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunil Patel: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Interventions

Cathartics

Intervention Hierarchy (Ancestors)

Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Sunil V Patel, MD MSc

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be aware of the arm they were assigned to. Colonoscopist performing the colonoscopy will be masked to the intervention and will be providing the assessment of the quality of bowel preparation. The investigators will be masked to the assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor and Attending Surgeon

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: November 21, 2018
• Primary Completion: December 31, 2022
• Study Completion: January 30, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

CA (1)