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Clinical Trial NCT06981650 for Colonoscopy Education is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Video Education to Improve First Time Colonoscopy Outcomes 362

Not yet recruiting
Clinical Trial NCT06981650 is an interventional study for Colonoscopy Education and is currently not yet recruiting. Enrollment is planned to begin on June 1, 2025 and continue until the study accrues 362 participants. Led by New York City Health and Hospitals Corporation, this study is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on May 21, 2025.
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 Bost...Show More
Official Title

Video Education to Improve First Time Colonoscopy Outcomes: A Prospective Randomized Control Trial.

Conditions
Colonoscopy Education
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • MED2024-555
NCT ID Number
NCT06981650
Start Date (Actual)
2025-06-01
Last Update Posted
2025-05-21
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
362
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
colonoscopy
Primary Purpose
Screening
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active Comparatoreducation
standard education
Education
standard talk and paper handout
Experimentaleducation plus video education
standard education plus an additional approach
video
use of a video
Education
standard talk and paper handout
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Boston Bowel Preparation Scale (categorical)
Boston Bowel Preparation Scale adequacy of preparation score ≥ 2 in all regions. Quality measured by the Boston Bowel Preparation Scale. Scores range from 0 through 3. Higher scores indicate a better outcome..
Perioperative/Periprocedural
Polyp detection rate proportion
Proportion of individuals undergoing a colonoscopy in whom at least one polyp is detected. Values range from 0 through 1. Higher values indicate a better outcome.
Perioperative/Periprocedural
Adenoma detection rate proportion
Proportion of individuals undergoing a colonoscopy in whom at least one adenomatous polyp is found. Values range from 0 through 1. Higher values indicate a better outcome.
Perioperative/Periprocedural
Cecal intubation rate proportion
Proportion of colonoscopies in which the endoscope successfully reaches the caecum. Values range from 0 through 1. Higher values indicate a better outcome.
Perioperative/Periprocedural
Withdrawal time
Duration in minutes taken to withdraw the colonoscope from the caecum to the rectum. Values range from 1 through 60. Higher values indicate a worse outcome.
Perioperative/Periprocedural
Adherence to bowel preparation instructions
Following what was told to do by bowel preparation instructions. Total of 7 original questions scored as no for 0 or yes for 1 with a total score ranging from 0 through 7. Higher values indicate a better outcome.
Perioperative/Periprocedural
Amsterdam Preoperative Anxiety and Information Scale
Self-assessed at baseline using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Scores range from 6 through 30. Higher scores greater anxiety.
baseline
Overall experience with the bowel preparation process
Self-report about experience with the bowel preparation process. One original question with 5 choices of very unpleasant, unpleasant , neutral , pleasant , very pleasant . There is no score. The best answer would be "very pleasant."
Perioperative/Periprocedural
Desire to undergo future colonoscopies if indicated
Self-report about having another colonoscopy. One original question with 5 choices of strongly disagree, disagree, neutral, agree , strongly agree. The best answer would be "strongly agree."
Perioperative/Periprocedural
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

all outpatients aged 18 to 75 years scheduled for their first screening colonoscopy

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● 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.
New York City Health and Hospitals Corporation logoNew York City Health and Hospitals Corporation
Study Responsible Party
John Trillo, Principal Investigator, Director of Gastroenetrology, South Brooklyn Health, New York City Health and Hospitals Corporation
Study Central Contact
Contact: John Trillo, MD, 718-616-4400, [email protected]
Contact: Joel Konlack, MD, 718-616-4400, [email protected]
No location data.