Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-14 @ 2:42 AM
Study NCT ID:
NCT03225560
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2017-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smart Phone App for COLOnoscopic PREParation
Sponsor:
Sunil Patel
Organization:
Study Overview
Official Title:
A Novel Smart Phone Application for Patients Undergoing COLOnoscopic Bowel PREParation: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLOPREP
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: