Colonoscopy EducationNCT06981650
Video Education to Improve First Time Colonoscopy Outcomes
A study testing video and education in people with Colonoscopy Education, run by New York City Health and Hospitals Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonoscopy Education
- What is being tested?
- video and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Video Education to Improve First Time Colonoscopy Outcomes: A Prospective Randomized Control Trial.
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.
Read the 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,
- Conditions
- Colonoscopy Education
- Being tested
- video, education
- Keywords
- colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videoBehavioural
use of a video
educationBehavioural
standard talk and paper handout
| Study group | Role | What they receive |
|---|---|---|
| education | Active comparator | standard education Receives: Behavioral: education |
| education plus video education | Experimental | standard education plus an additional approach Receives: Behavioral: video; Behavioral: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: Perioperative/Periprocedural
Secondary outcomes (9)
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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Trillo, New York City Health and Hospitals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981650
- Sponsor's protocol ID
- MED2024-555
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentfied data based upon a reasonable request
Publications
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.
PubMed 29847488
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Education to Improve First Time Colonoscopy Outcomes: A Prospective Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT06981650
- Acronym / sponsor ID
- MED2024-555
- Conditions
- Colonoscopy Education
- Keywords
- colonoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| education | Active comparator | Behavioral: educationstandard education |
| education plus video education | Experimental | Behavioral: video, Behavioral: educationstandard education plus an additional approach |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| videouse of a video | Behavioural | education plus video education |
| educationstandard talk and paper handout | Behavioural | education, education plus video education |
Primary outcome
Boston Bowel Preparation Scale (continuous)
Time frame: Perioperative/Periprocedural
Quality of bowel preparation measured by the Boston Bowel Preparation Scale. Scores range from 0 through 3. Higher scores indicate a better outcome..
9 secondary outcomes
Boston Bowel Preparation Scale (categorical)
Time frame: Perioperative/Periprocedural
Polyp detection rate proportion
Time frame: Perioperative/Periprocedural
Adenoma detection rate proportion
Time frame: Perioperative/Periprocedural
Cecal intubation rate proportion
Time frame: Perioperative/Periprocedural
Withdrawal time
Time frame: Perioperative/Periprocedural
Adherence to bowel preparation instructions
Time frame: Perioperative/Periprocedural
Amsterdam Preoperative Anxiety and Information Scale
Time frame: baseline
Overall experience with the bowel preparation process
Time frame: Perioperative/Periprocedural
Desire to undergo future colonoscopies if indicated
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Background: PubMed 29847488Mahmood 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.
- Individual participant dataSharing planned: Yes. Deidentfied data based upon a reasonable request
Related trials for Colonoscopy Education
Recruiting
Bowel Preparation Quality Following Video-Based Intervention and Educational Booklet Versus Standard of Care in an Outpatient Setting
Bowel Preparation Quality, Colonoscopy
Recruiting
The Effect of Video-Based Education on Colonoscopy Preparation
Bowel Preparation Quality, Colonoscopy
Enrolling by invitation
Artificial Intelligence-assisted Colonoscopy, Tandem Study
Artificial Intelligence (AI), Colonoscopy Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing video and education in people with Colonoscopy Education, run by New York City Health and Hospitals Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Trillo, MD (718-616-4400, John.Trillo@nychhc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Scale (continuous) (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06981650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025; AzTrials last refreshed its copy on 3 Nov 2026.