NCT02013505

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

December 11, 2013

Last Update Submit

July 27, 2023

Conditions

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adenoma detection rate

    At time of colonoscopy

Study Arms (2)

Instructions printed on a paper.

NO INTERVENTION

There will be no intervention.

Paper and video instructions

EXPERIMENTAL

.Instructions printed on paper and a educational video.

Other: Educational video

Interventions

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.

Paper and video instructions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \< 18 years age
  • Subjects from whom consent cannot be obtained for any reason.
  • Subjects who are scheduled for colonoscopy as in patient
  • 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.
  • Subjects who are advised to undergo bowel prep for more than one day.
  • Subjects undergoing bowel prep with medications other than Colyte.
  • Subjects who do not have access to equipment to watch the video (TV/CD player)
  • Pregnant patients
  • Prisoners
  • Subjects who are not able to read or understand English.
  • (j)Subjects who had bowel resection surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Dilip Bearelly, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 17, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations