Smart Phone App for COLOnoscopic PREParation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer Screening, Colonoscopy, Mass Screening

Intervention / Treatment
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* Other: Bowel Preparation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart Phone Application<br>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<br>* 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.<br>|
| Active Comparator: Traditional Paper Instructions<br>Traditional paper instructions for bowel preparation | Other: Bowel Preparation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal Intubation | The ability for the colonoscopist to intubate the cecum | At time of colonoscopy | 
| Adenomatous polyp detection | The number of adenomatous polyps detected | At time of colonoscopy | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smart Phone Application, Bowel Preparation, Colorectal Cancer Screening