- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07582731
A Single-Center Randomized Controlled Trial on the Impact of Disease Subtype-Based Active Video Education on Bowel Preparation Quality in Patients With Inflammatory Bowel Disease
May 12, 2026 updated by: Jie Liang
This single-center, prospective, randomized controlled trial evaluates whether disease subtype-based active video education improves bowel preparation quality in patients with inflammatory bowel disease (IBD) undergoing colonoscopy.
300 IBD patients will be randomized 1:1 to standard education plus subtype-specific video education (intervention) or standard education alone (control).
Primary outcome: Boston Bowel Preparation Scale (BBPS) score.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Inflammatory bowel disease (IBD) patients often have suboptimal bowel preparation before colonoscopy due to chronic inflammation, strictures, and poor adherence to preparation protocols.
Conventional written and verbal education has shown limited effectiveness in this population.
This trial will develop and test an active video education intervention tailored to IBD subtypes (ulcerative colitis or Crohn's disease), delivered via WeChat before colonoscopy.
Patients will be randomized 1:1 to either the intervention group or the control group.
The primary endpoint is bowel preparation quality measured by the total BBPS score.
Secondary outcomes include adequate/excellent preparation rates, cecal intubation rate and time, patient compliance, knowledge scores, adverse events, anxiety levels, and satisfaction.
Outcome assessors will be blinded to group assignment to reduce bias.
Statistical analyses will be performed using appropriate methods based on data distribution.
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jie Liang, MD, PhD
- Phone Number: 029-84771535
- Email: liangjie@fmmu.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 18 and 75 years, inclusive.
- Confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's disease (CD) according to standard clinical guidelines.
- Scheduled for elective colonoscopy for IBD monitoring or disease activity assessment.
- Able to understand written and verbal instructions and to use a smartphone to view video education materials.
- Voluntary participation with written informed consent.
Exclusion Criteria:
- Absolute contraindications to colonoscopy, including acute gastrointestinal perforation, fulminant colitis, toxic megacolon, or hemodynamic instability.
- History of total or subtotal colectomy.
- Acute or chronic intestinal obstruction.
- Severe cardiac, pulmonary, hepatic, or renal insufficiency (eGFR <30 mL/min/1.73m², NYHA class III/IV).
- Severe psychiatric or cognitive impairment that prevents understanding of the study requirements.
- Inability or unwillingness to provide written informed consent.
- Pregnant or breastfeeding women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group (Active Video Education Group)
Patients receive conventional bowel preparation education (written instructions + 10-minute oral explanation) plus disease subtype-specific active video education delivered via WeChat.
Patients are required to watch the tailored video at least once within 3 days before colonoscopy.
No investigational drug or device is involved.
Sample size: 150.
|
A structured, subtype-specific educational video program tailored for patients with inflammatory bowel disease (IBD).
The videos are customized based on IBD subtype (ulcerative colitis/Crohn's disease), disease activity (active/remission), and Crohn's disease behavior (stricturing/fistulizing). It covers key topics including dietary restrictions, laxative intake instructions, symptom management, and practical problem-solving strategies to improve understanding and adherence to bowel preparation protocols.
The video is delivered via WeChat link.
Other Names:
standard bowel preparation education
|
|
Active Comparator: Control Group (Conventional Education Group)
Patients receive only standard bowel preparation education, including unified written instructions and a 10-minute verbal explanation, with no additional video education.
Sample size: 150.
|
standard bowel preparation education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
Time Frame: Periprocedural (during colonoscopy)
|
The Boston Bowel Preparation Scale (BBPS) is a validated scoring system to assess the cleanliness of three colonic segments: right colon (including cecum and ascending colon), transverse colon (including hepatic flexure and splenic flexure), and left colon (including descending colon, sigmoid colon, and rectum).
Each segment is scored from 0 (unprepared) to 3 (excellent) by the endoscopist during withdrawal.
The total BBPS score ranges from 0 to 9. Higher scores indicate better bowel preparation.
|
Periprocedural (during colonoscopy)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adequate Bowel Preparation Rate
Time Frame: Periprocedural (during colonoscopy)
|
Proportion of patients with adequate bowel preparation, defined as total BBPS score ≥ 6.
|
Periprocedural (during colonoscopy)
|
|
Excellent Bowel Preparation Rate
Time Frame: Periprocedural (during colonoscopy)
|
Proportion of patients with excellent bowel preparation, defined as total BBPS score ≥ 8.
|
Periprocedural (during colonoscopy)
|
|
Cecal Intubation Rate
Time Frame: Periprocedural (during colonoscopy)
|
Proportion of patients in whom the cecum is successfully intubated during colonoscopy.
|
Periprocedural (during colonoscopy)
|
|
Cecal Intubation Time
Time Frame: Periprocedural (during colonoscopy)
|
Time (in seconds) required to reach and intubate the cecum, measured from the time the colonoscope is inserted until cecal intubation is confirmed.
|
Periprocedural (during colonoscopy)
|
|
Bowel Preparation Compliance Rate
Time Frame: After bowel preparation and before colonoscopy (assessed on the day of procedure)
|
Three adherence measures: (1) dietary restriction compliance (yes/no), (2) laxative intake completion (≥75% of prescribed dose as yes), (3) video viewing completion (intervention group only, at least one full viewing).
|
After bowel preparation and before colonoscopy (assessed on the day of procedure)
|
|
Patient Experience - Anxiety, Tolerance, Satisfaction, Willingness to Repeat
Time Frame: After bowel preparation and before colonoscopy (assessed on the day of procedure)
|
Assessed via patient-reported questionnaire using visual analog scales or Likert scales (0-10).
Components: pre-procedural anxiety level, tolerance of bowel preparation process, overall satisfaction, and willingness to repeat colonoscopy if needed.
|
After bowel preparation and before colonoscopy (assessed on the day of procedure)
|
|
Incidence of Adverse Events
Time Frame: During bowel preparation and up to 7 days post-colonoscopy
|
Number and proportion of patients experiencing adverse events related to bowel preparation, including nausea, vomiting, abdominal pain, bloating, and electrolyte abnormalities.
|
During bowel preparation and up to 7 days post-colonoscopy
|
|
Bowel Preparation Knowledge Score
Time Frame: After bowel preparation and before colonoscopy (assessed on the day of procedure)
|
Patient knowledge about bowel preparation assessed using a 0-10 point questionnaire, with higher scores indicating better knowledge.
|
After bowel preparation and before colonoscopy (assessed on the day of procedure)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
May 6, 2026
First Submitted That Met QC Criteria
May 12, 2026
First Posted (Actual)
May 13, 2026
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20262099-F-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The individual participant data (IPD) for this study will not be made available to other researchers, due to concerns related to participant privacy, data confidentiality, and institutional data sharing policies.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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