Colonoscopy Educational Video Upon Inner City Population

NCT ID: NCT02906969

Last Updated: 2016-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Other Surgical Procedures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colonoscopy educational Video

Brief educational video of colonoscopy to determine comprehension and quality of bowel preparation.

Group Type EXPERIMENTAL

Colonoscopy Educational Video

Intervention Type OTHER

Brief Video utilization to assess comprehension and evaluation bowel preparation quality

Control

Non-colonoscopy video as a control.

Group Type PLACEBO_COMPARATOR

Placebo Educational Video

Intervention Type OTHER

Brief Video utilization to provide placebo information and evaluation bowel preparation quality

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colonoscopy Educational Video

Brief Video utilization to assess comprehension and evaluation bowel preparation quality

Intervention Type OTHER

Placebo Educational Video

Brief Video utilization to provide placebo information and evaluation bowel preparation quality

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age 18-85
* undergoing initial outpatient colonoscopy
* willing to participate in and sign consent for this study
* Morning session of colonoscopy procedure

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Drexel University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.

Reference Type BACKGROUND
PMID: 12135020 (View on PubMed)

Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.

Reference Type BACKGROUND
PMID: 21483463 (View on PubMed)

Pillai A, Menon R, Oustecky D, Ahmad A. Educational Colonoscopy Video Enhances Bowel Preparation Quality and Comprehension in an Inner City Population. J Clin Gastroenterol. 2018 Jul;52(6):515-518. doi: 10.1097/MCG.0000000000000893.

Reference Type DERIVED
PMID: 28742732 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1203000992

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.