Clinical trial NCT06981650: Video Education to Improve First Time Colonoscopy Outcomes
Official title: Video Education to Improve First Time Colonoscopy Outcomes: A Prospective Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colonoscopy Education
Keywords: colonoscopy
Lead sponsor: New York City Health and Hospitals Corporation
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: The investigators compare video education plus standard education versus standard education for bowel preparation before a colonoscopy and include a number of languages including English, Spanish, Russian, Haitian Creole, and Urdu. The educational content also includes psychological content based upon the Theory of Planned Behavior. The primary outcome will be the quality of bowel preparation, as measured by the Boston Bowel Preparation Scale (BBPS) score,

Eligibility criteria: Inclusion Criteria: all outpatients aged 18 to 75 years scheduled for their first screening colonoscopy

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Exclusion Criteria: ● Contraindications for colonoscopy

* 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.

Primary outcomes:
measure: Boston Bowel Preparation Scale (continuous)
timeFrame: Perioperative/Periprocedural
Secondary outcomes:
measure: Boston Bowel Preparation Scale (categorical)
timeFrame: Perioperative/Periprocedural
measure: Polyp detection rate proportion
timeFrame: Perioperative/Periprocedural
measure: Adenoma detection rate proportion
timeFrame: Perioperative/Periprocedural
measure: Cecal intubation rate proportion
timeFrame: Perioperative/Periprocedural
measure: Withdrawal time
timeFrame: Perioperative/Periprocedural
measure: Adherence to bowel preparation instructions
timeFrame: Perioperative/Periprocedural
measure: Amsterdam Preoperative Anxiety and Information Scale
timeFrame: baseline
measure: Overall experience with the bowel preparation process
timeFrame: Perioperative/Periprocedural
measure: Desire to undergo future colonoscopies if indicated
timeFrame: Perioperative/Periprocedural
Other outcomes:
Locations:
Study officials:
References:
citation: 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.