A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy

Bowel Dysfunction Clinical Trial

Official title:

A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02013505
• Other study ID #: 1203774
• Status: Terminated
• Phase: N/A
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 298
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Dysfunction
• Intestinal Diseases

Intervention

Other:
• Educational video
An educational video was developed based on the current paper instructions for bowel preparation. The video included a physician explaining the process, using more images and short clip videos of the example. The script of the video was approved by the patient education department of the University Hospital and language adjusted to 6th grade level.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of bowel preparation	Quality of bowel preparation at the time when the colonoscopy procedure is performed as reported by the physician performing the colonoscopy.	At the time of colonoscopy
Secondary	Adenoma detection rate	Number of patients undergoing screening colonoscopy for average risk in whom an adenoma was detected.	At time of colonoscopy