Smart Phone App for COLOnoscopic PREParation (COLOPREP)
Primary Purpose
Colorectal Cancer Screening, Colonoscopy, Mass Screening
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bowel Preparation
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer Screening focused on measuring Smart Phone Application, Bowel Preparation, Colorectal Cancer Screening
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
Sites / Locations
- Kingston Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Smart Phone Application
Traditional Paper Instructions
Arm Description
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.
Traditional paper instructions for bowel preparation
Outcomes
Primary Outcome Measures
Quality of Bowel Preparation
The quality of bowel preparation as assessed by the validated Boston and Aronchick bowel preparation scales
Secondary Outcome Measures
Cecal Intubation
The ability for the colonoscopist to intubate the cecum
Adenomatous polyp detection
The number of adenomatous polyps detected
Patient reported adherence to bowel preparation instructions
Patient questionnaire used to determine the adherence to the pre-specified bowel preparation instructions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03225560
Brief Title
Smart Phone App for COLOnoscopic PREParation
Acronym
COLOPREP
Official Title
A Novel Smart Phone Application for Patients Undergoing COLOnoscopic Bowel PREParation: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sunil Patel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening, Colonoscopy, Mass Screening
Keywords
Smart Phone Application, Bowel Preparation, Colorectal Cancer Screening
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Smart Phone Application
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Paper Instructions
Arm Type
Active Comparator
Arm Description
Traditional paper instructions for bowel preparation
Intervention Type
Other
Intervention Name(s)
Bowel Preparation
Intervention Description
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 Outcome Measure Information:
Title
Quality of Bowel Preparation
Description
The quality of bowel preparation as assessed by the validated Boston and Aronchick bowel preparation scales
Time Frame
At time of colonoscopy
Secondary Outcome Measure Information:
Title
Cecal Intubation
Description
The ability for the colonoscopist to intubate the cecum
Time Frame
At time of colonoscopy
Title
Adenomatous polyp detection
Description
The number of adenomatous polyps detected
Time Frame
At time of colonoscopy
Title
Patient reported adherence to bowel preparation instructions
Description
Patient questionnaire used to determine the adherence to the pre-specified bowel preparation instructions.
Time Frame
At time of colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunil V Patel, MD MSc
Phone
6135496666
Ext
7995
Email
Sunil.Patel@kingstonhsc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Connie E Taylor
Phone
613-544-3400
Ext
3320
Email
connie.taylor2@kingstonhsc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil V Patel, MD MSc
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie E Taylor
Phone
613-544-3400
Ext
3320
Email
connie.taylor2@kingstonhsc.ca
First Name & Middle Initial & Last Name & Degree
Sunil V Patel, MD BSc
Phone
613-548-3232
Ext
7995
Email
Sunil.Patel@kingstonhsc.ca
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Smart Phone App for COLOnoscopic PREParation
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