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Study on the Impact of Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy

Primary Purpose

Colon Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aiddly (Web Site)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colon Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 19 or greater
  • Patients scheduled for a colonoscopy using a doctors "normal prep" as outpatients
  • Willing to participate by filling out the survey
  • Must be able to read and understand English
  • Must have ability to use email, have a functioning email account, and are willing to be contacted by email.

Exclusion Criteria:

  • Unable to speak English
  • Unwilling to participate in reading online materials

Sites / Locations

  • St. Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Web Group

Paper Group

Arm Description

Patients given web site (aiddly) instructions for colonoscopy

Patients given paper instructions for colonoscopy

Outcomes

Primary Outcome Measures

Patients with Excelent Colonoscopy preparation
To determine the effectiveness of web-based instructions for patients preparing for colonoscopy by comparing the percentage of patients that achieve an excellent Boston Bowel Preparation score when following the web-based instructions compared to the control arm of patients receiving paper written instructions.

Secondary Outcome Measures

Benefit and satisfaction to patients of this method of patient education.
To determine through follow-up survey the benefit and satisfaction to patients of this method of patient education.
Bowel preparation tolerability with this method of patient education.
To determine through follow-up survey differences in bowel preparation tolerability with this method of patient education.
Use of web-based educational platform
To determine the number of patients who cannot use or participate in the web-based educational platform and through survey results determine limiting factors of access and use.

Full Information

First Posted
May 13, 2015
Last Updated
October 24, 2017
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02466724
Brief Title
Study on the Impact of Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy
Official Title
Randomized Prospective Study on the Impact of the Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Colorectal cancer (CRC) is a common and life threatening condition that will affect one in thirteen individuals. Colonoscopy is the most commonly used procedure to identify colorectal malignancies or precancerous lesions at an earlier stage, which affords an opportunity for cure. However, low level of bowel cleanliness hinders polyp detection and therefore can limit colonoscopy effectiveness. Historically, the majority of the studies have focused on pharmacological factors to optimize bowel preparation quality. Recently, non-pharmacological factors have been found to have significant increases in bowel preparation quality. The purpose of this study is to evaluate the effectiveness of web-based instructions vs. the historical phone/letter instructions given to patients planning to have a colonoscopy.
Detailed Description
This study is a prospective randomized trial. Four hundred and fifty consecutive eligible patients will be randomized to ideally have two hundred and twenty five patients in each arm. Those who will have traditional paper based instructions and those who will be using an online system. Both groups will receive their instructions by the research assistant prior to leaving the office after being consented. The paper based instructions will be given as a handout and those in the online group will receive their bowel preparation instructions via an email sent by a scheduling assistant

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web Group
Arm Type
Experimental
Arm Description
Patients given web site (aiddly) instructions for colonoscopy
Arm Title
Paper Group
Arm Type
No Intervention
Arm Description
Patients given paper instructions for colonoscopy
Intervention Type
Device
Intervention Name(s)
Aiddly (Web Site)
Intervention Description
A website designed to better educate patients on how to prepare for their colonoscopies
Primary Outcome Measure Information:
Title
Patients with Excelent Colonoscopy preparation
Description
To determine the effectiveness of web-based instructions for patients preparing for colonoscopy by comparing the percentage of patients that achieve an excellent Boston Bowel Preparation score when following the web-based instructions compared to the control arm of patients receiving paper written instructions.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Benefit and satisfaction to patients of this method of patient education.
Description
To determine through follow-up survey the benefit and satisfaction to patients of this method of patient education.
Time Frame
Baseline
Title
Bowel preparation tolerability with this method of patient education.
Description
To determine through follow-up survey differences in bowel preparation tolerability with this method of patient education.
Time Frame
Baseline
Title
Use of web-based educational platform
Description
To determine the number of patients who cannot use or participate in the web-based educational platform and through survey results determine limiting factors of access and use.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 19 or greater Patients scheduled for a colonoscopy using a doctors "normal prep" as outpatients Willing to participate by filling out the survey Must be able to read and understand English Must have ability to use email, have a functioning email account, and are willing to be contacted by email. Exclusion Criteria: Unable to speak English Unwilling to participate in reading online materials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Enns, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada

12. IPD Sharing Statement

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Study on the Impact of Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy

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