An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy
Primary Purpose
Colon Cancer Screening
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational video
Sponsored by
About this trial
This is an interventional screening trial for Colon Cancer Screening focused on measuring colonoscopy
Eligibility Criteria
Inclusion Criteria:
- English speaking
- Access to text messaging and the internet (mobile phone access alone was considered sufficient)
- Prescribed standard split-dose bowel preparation
- Able to provide informed consent via telephone.
Exclusion Criteria:
- Pregnant
- Mentally impaired
- Undergoing screening or surveillance for inflammatory bowel disease .
Sites / Locations
- Washington University in St. Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
standard education
educational video
Arm Description
Outcomes
Primary Outcome Measures
Adequacy of bowel prep
adequacy of colonoscopy bowel prep was scored from 0 (worst) to 9 (best).
Secondary Outcome Measures
Full Information
NCT ID
NCT04491565
First Posted
July 24, 2020
Last Updated
July 30, 2020
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04491565
Brief Title
An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy
Official Title
An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
February 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
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
The investigators aimed to determine whether an interactive, online educational platform could improve procedure show rates and bowel preparation scores in an outpatient population presenting for routine colonoscopy.
Detailed Description
The investigators performed a prospective, endoscopist-blinded, randomized controlled trial at a hospital-based outpatient endoscopy center. Eligible patients were randomized to two groups. Both groups received verbal and written instructions per standard care, while the intervention group received access to an interactive, on-line video. Primary outcomes were bowel preparation scores graded using the Boston Bowel Prep Score (BBPS), procedure show rates, patient satisfaction, and pre-procedure anxiety. Secondary outcomes included adenoma detection rate, mean bowel prep score per colonic segment, total number of polyps detected, and complication rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Screening
Keywords
colonoscopy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard education
Arm Type
No Intervention
Arm Title
educational video
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
educational video
Intervention Description
an interactive educational video was viewed by participants in the intervention arm.
Primary Outcome Measure Information:
Title
Adequacy of bowel prep
Description
adequacy of colonoscopy bowel prep was scored from 0 (worst) to 9 (best).
Time Frame
intra procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
English speaking
Access to text messaging and the internet (mobile phone access alone was considered sufficient)
Prescribed standard split-dose bowel preparation
Able to provide informed consent via telephone.
Exclusion Criteria:
Pregnant
Mentally impaired
Undergoing screening or surveillance for inflammatory bowel disease .
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy
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