- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491565
An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy
July 30, 2020 updated by: Dayna Early, Washington University School of Medicine
An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
270
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University in St. Louis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: standard education
|
|
|
Active Comparator: educational video
|
an interactive educational video was viewed by participants in the intervention arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adequacy of bowel prep
Time Frame: intra procedure
|
adequacy of colonoscopy bowel prep was scored from 0 (worst) to 9 (best).
|
intra procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2019
Primary Completion (Actual)
February 7, 2020
Study Completion (Actual)
February 7, 2020
Study Registration Dates
First Submitted
July 24, 2020
First Submitted That Met QC Criteria
July 24, 2020
First Posted (Actual)
July 29, 2020
Study Record Updates
Last Update Posted (Actual)
August 3, 2020
Last Update Submitted That Met QC Criteria
July 30, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201909053
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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