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Trial record 89 of 318 for:    colon cancer | ( Map: Canada )

Smart Phone App for COLOnoscopic PREParation (COLOPREP)

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ClinicalTrials.gov Identifier: NCT03225560
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Sunil Patel, Kingston Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Screening Colonoscopy Mass Screening Other: Bowel Preparation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Triple (Care Provider, Investigator, Outcomes 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.

Primary Purpose: Treatment
Official Title: A Novel Smart Phone Application for Patients Undergoing COLOnoscopic Bowel PREParation: A Randomized Controlled Trial
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Smart Phone Application
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
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.

Active Comparator: Traditional Paper Instructions
Traditional paper instructions for bowel preparation
Other: Bowel Preparation
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 Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225560


Contacts
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Contact: Sunil V Patel, MD MSc 6135496666 ext 7995 Sunil.Patel@kingstonhsc.ca
Contact: Connie E Taylor 613-544-3400 ext 3320 connie.taylor2@kingstonhsc.ca

Locations
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Canada, Ontario
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 5G2
Contact: Connie E Taylor    613-544-3400 ext 3320    connie.taylor2@kingstonhsc.ca   
Contact: Sunil V Patel, MD BSc    613-548-3232 ext 7995    Sunil.Patel@kingstonhsc.ca   
Sponsors and Collaborators
Sunil Patel
Investigators
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Principal Investigator: Sunil V Patel, MD MSc Queen's University

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Responsible Party: Sunil Patel, Assistant Professor and Attending Surgeon, Kingston Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03225560     History of Changes
Other Study ID Numbers: 6020364
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunil Patel, Kingston Health Sciences Centre:
Smart Phone Application
Bowel Preparation
Colorectal Cancer Screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases