Clinical trial NCT02013505: A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy
Official title: A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bowel Dysfunction
Keywords: Colonoscopy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators hypothesised that a video based patient education will help patients understand the process of colon cleansing prior to a colonoscopy procedure and hence will result in clean colons that will may help physician perform a better quality examination.

Detailed description: After obtaining consent over phone, the investigators randomly assigned assigned participants to receive either the standard paper based instructions or receive an educational video in addition to the standard paper based instruction. Physicians performing the procedure were blinded to this assignment. The investigators obtained information relating to the cleanliness of the colon as noted during the colonoscopy examination. The investigators obtained this information from the colonoscopy reports. The investigators also obtained information regarding colon polyps,wanting to see if there is any difference in the number of patients in whom adenomatous polyps were detected.

Outcome measures:

Primary Out come:

1.Quality of bowel preparation

Secondary outcome:

1. Adenoma detection rate
2. Rate of incomplete procedures due to poor bowel prep.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. Subjects who have the ability to give consent
3. Subjects who are scheduled for colonoscopy as out patient
4. Subjects consenting to participate in the study
5. Subjects who are able to read and understand English

Exclusion Criteria:

1. \< 18 years age
2. Subjects from whom consent cannot be obtained for any reason.
3. Subjects who are scheduled for colonoscopy as in patient
4. Subjects who are scheduled for colonoscopy within a time period or a situation where the educational material cannot be properly delivered to the study participant.
5. Subjects who are advised to undergo bowel prep for more than one day.
6. Subjects undergoing bowel prep with medications other than Colyte.
7. Subjects who do not have access to equipment to watch the video (TV/CD player)
8. Pregnant patients
9. Prisoners
10. Subjects who are not able to read or understand English.

(j)Subjects who had bowel resection surgery

Primary outcomes:
measure: Quality of bowel preparation
timeFrame: At the time of colonoscopy
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: At time of colonoscopy
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Dilip Bearelly, MD
role: PRINCIPAL_INVESTIGATOR
References: