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Completed

NCT Number: NCT03225560

Smart Phone App for COLOnoscopic PREParation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 5G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Cecal Intubation

    Time frame: At time of colonoscopy

    The ability for the colonoscopist to intubate the cecum

  2. Adenomatous polyp detection

    Time frame: At time of colonoscopy

    The number of adenomatous polyps detected

  3. Patient reported adherence to bowel preparation instructions

    Time frame: At time of colonoscopy

    Patient questionnaire used to determine the adherence to the pre-specified bowel preparation instructions.

Sponsors and collaborators

Lead sponsor

Sunil Patel

Other

Registry information

Official study title

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

Acronym: COLOPREP

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jul 21, 2017
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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