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Not yet recruiting NCT07582731

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

No phase Interventional Inflammatory Bowel Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Disease Subtype-Based Active Video Education, standard bowel preparation education.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Diseases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Interventions

  • 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
  • Behavioral standard bowel preparation education
    standard bowel preparation education

Primary outcome measures

  • Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS) [Time frame: Periprocedural (during colonoscopy)]
Secondary outcome measures (8)
  • Adequate Bowel Preparation Rate [Time frame: Periprocedural (during colonoscopy)]
  • Excellent Bowel Preparation Rate [Time frame: Periprocedural (during colonoscopy)]
  • Cecal Intubation Rate [Time frame: Periprocedural (during colonoscopy)]
  • Cecal Intubation Time [Time frame: Periprocedural (during colonoscopy)]
  • Bowel Preparation Compliance Rate [Time frame: 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)]
  • Incidence of Adverse Events [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

China · 12 centers
  • Peking Union Medical College Hospital — Beijing
  • Shengjing Hospital of China Medical University — Shenyang
  • Affiliated Hospital of Qinghai University — Xining
  • The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an
  • Air Force 986 Hospital — Xi'an
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
  • Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
  • Changhai Hospital, Naval Medical University — Shanghai
  • … and 4 more centers

Identifiers

NCT: NCT07582731 · KY20262099-F-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗