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Colonoscopy Educational Video Upon Inner City Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906969
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Drexel University
  Purpose

Background:

The investigators assessed the use of a colonoscopy instructional video to improve both bowel preparation and education prior to procedure. Preceding studies have been vague, pinning patient education via diagrams and text as both pivotal and useless for compliance in bowel preparations. These studies however lacked assessment of comprehension prior to procedure.

Methodology:

This is a prospective study of diverse, inner city outpatient university center, first time colonoscopy patients given 1 of 2 on-site videos and written/verbal instruction. Experimentals saw a 5 min video on the purpose of colonoscopy, bowel preparation, pre-colonoscopy diet, and proper laxative use. Controls saw a 5 min video from the same spokesperson on upper endoscopy; which was trivial. Both groups were given a quiz within 30 days of the colonoscopy on demographics, and 14 test questions about colonoscopy and preparation. Subsequently, endoscopists used the additive Ottawa scale to rate quality of preparation (range 0-14) via: fluid (0=sm,1=mod, 2=lg) and cleanliness in each the right, mid and rectosigmoid colon, (0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate).


Condition Intervention
Other Surgical Procedures Other: Colonoscopy Educational Video Other: Placebo Educational Video

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Educational Colonoscopy Video Enhances Bowel Preparation Quality and Comprehension in an Inner City Population

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Primary outcome improvement in adequate bowel preparations [ Time Frame: in 30 days retention from the video ]
    Bowel preparation quality indicator using Ottawa bowel prep scale.

  • Comprehension of colonoscopy/colorectal cancer screening [ Time Frame: in 30 days retention from the video ]
    Questionnaire


Enrollment: 104
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colonoscopy educational Video
Brief educational video of colonoscopy to determine comprehension and quality of bowel preparation.
Other: Colonoscopy Educational Video
Brief Video utilization to assess comprehension and evaluation bowel preparation quality
Placebo Comparator: Control
Non-colonoscopy video as a control.
Other: Placebo Educational Video
Brief Video utilization to provide placebo information and evaluation bowel preparation quality

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria:

  • Patients were excluded if they had dementia or
  • cognitive impairment or
  • if they did not have a pre-procedural office visit.

Inclusion Criteria:

  • age 18-85
  • undergoing initial outpatient colonoscopy
  • willing to participate in and sign consent for this study
  • Morning session of colonoscopy procedure
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT02906969     History of Changes
Other Study ID Numbers: 1203000992
First Submitted: June 13, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No