NCT06981650

Brief Summary

The investigators compare video education plus standard education versus standard education for bowel preparation before a colonoscopy. The primary outcome will be the quality of bowel preparation.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
362

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jun 2025

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

April 24, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

April 24, 2025

Last Update Submit

May 12, 2025

Conditions

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Boston Bowel Preparation Scale (continuous)

    Quality of bowel preparation measured by the Boston Bowel Preparation Scale. Scores range from 0 through 3. Higher scores indicate a better outcome..

    Perioperative/Periprocedural

Secondary Outcomes (9)

  • Boston Bowel Preparation Scale (categorical)

    Perioperative/Periprocedural

  • Polyp detection rate proportion

    Perioperative/Periprocedural

  • Adenoma detection rate proportion

    Perioperative/Periprocedural

  • Cecal intubation rate proportion

    Perioperative/Periprocedural

  • Withdrawal time

    Perioperative/Periprocedural

  • +4 more secondary outcomes

Study Arms (2)

education

ACTIVE COMPARATOR

standard education

Behavioral: education

education plus video education

EXPERIMENTAL

standard education plus an additional approach

Behavioral: videoBehavioral: education

Interventions

videoBEHAVIORAL

use of a video

education plus video education
educationBEHAVIORAL

standard talk and paper handout

educationeducation plus video education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • History of bowel surgery, particularly colorectal surgery
  • Severe comorbid conditions (e.g., impaired hepatic, renal or bone marrow function, congestive heart failure, recent coronary artery disease)
  • Chronic constipation (typically \<3 bowel movements per week with hard stools, a feeling of incomplete evacuation, or abdominal discomfort) requiring the use of laxatives
  • Pregnancy or lactation
  • Prisoners
  • Diagnosis of inflammatory bowel disease
  • Inability to use video presentation devices (e.g., blindness)
  • Active cancers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018 Aug;30(8):819-826. doi: 10.1097/MEG.0000000000001175.

    PMID: 29847488BACKGROUND

MeSH Terms

Interventions

Videotape RecordingEducational Status

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionSocioeconomic FactorsPopulation Characteristics

Central Study Contacts

Joel Konlack, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenetrology, South Brooklyn Health

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 21, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Deidentfied data based upon a reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After study using data is published.
Access Criteria
Academic researchers