A Multi-Center Randomized Controlled Trial on the Impact of Disease Subtype-Based Active Video Education on Bowel Preparation Quality in Patients With Inflammatory Bowel Disease

June 13, 2026 updated by: Jie Liang
This multi-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. A total of 600 IBD patients from 13 centers will be randomized 1:1 to standard education plus subtype-specific video education (intervention group) or standard education alone (control group). The primary outcome is the 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 multi-center 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. A total of 600 patients from 13 participating hospitals across China will be randomized 1:1 to either the intervention group or the control group. Randomization will be stratified by center using a computer-generated sequence with allocation concealment (sealed, opaque envelopes). 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 account for center effects (e.g., using mixed-effects models or including center as a covariate) and will be performed using appropriate methods based on data distribution.

Study Type

Interventional

Enrollment (Estimated)

600

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

Study Locations

  • China
    • BeijingBeijing
      • Beijing, BeijingBeijing, China, 100730
        • Peking Union Medical College Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital Of China Medical University
        • Contact:
    • Qinghai
      • Xining, Qinghai, China, 810001
        • Affiliated Hospital of Qinghai University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • The Second Affiliated Hospital of Xi'An Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710054
        • Air Force 986 Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Changhai Hospital, Naval Medical University
      • Shanghai, Shanghai Municipality, China, 200127
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Jun Shen, Professor
          • Phone Number: 021-58752345
          • Email: xck@renji.com
      • Shanghai, Shanghai Municipality, China, 200025
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Heping Hospital Affiliated to Changzhi Medical College
        • Contact:
      • Linfen, Shanxi, China, 041000
        • Linfen Central Hospital
        • Contact:
      • Yuncheng, Shanxi, China, 044000
        • Yuncheng Central Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:

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:

  1. Age between 18 and 75 years, inclusive.
  2. Confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's disease (CD) according to standard clinical guidelines.
  3. Scheduled for elective colonoscopy for IBD monitoring or disease activity assessment.
  4. Able to understand written and verbal instructions and to use a smartphone to view video education materials.
  5. Voluntary participation with written informed consent.

Exclusion Criteria:

  1. Absolute contraindications to colonoscopy, including acute gastrointestinal perforation, fulminant colitis, toxic megacolon, or hemodynamic instability.
  2. History of total or subtotal colectomy.
  3. Acute or chronic intestinal obstruction.
  4. Severe cardiac, pulmonary, hepatic, or renal insufficiency (eGFR <30 mL/min/1.73m², NYHA class III/IV).
  5. Severe psychiatric or cognitive impairment that prevents understanding of the study requirements.
  6. Inability or unwillingness to provide written informed consent.
  7. 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: 300.
Behavioral: Disease Subtype-Based Active Video Education
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:
  • WeChat-Based Personalized IBD Video Education
Behavioral: standard bowel preparation education
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: 300.
Behavioral: standard bowel preparation education
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

Jie Liang

Collaborators

Peking Union Medical College Hospital
RenJi Hospital
Shengjing Hospital
Xijing Hospital of Digestive Diseases
Ruijin Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
First Affiliated Hospital of Xinjiang Medical University
Changzhi Medical College
Affiliated Hospital of Qinghai University
Air Force 986 Hospital
Changhai hospital of Navy Medical University
Shanxi Yuncheng Central Hospital
The Central Hospital of Linfen

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)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

June 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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