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

Jie Liang600 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Interventions

Disease Subtype-Based Active Video EducationBEHAVIORAL

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.

standard bowel preparation educationBEHAVIORAL

standard bowel preparation education

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (12)

Peking Union Medical College Hospital

Beijing, BeijingBeijing, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Affiliated Hospital of Qinghai University

Xining, Qinghai, China

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Air Force 986 Hospital

Xi'an, Shaanxi, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, China

RECRUITING

Heping Hospital affiliated to Changzhi Medical College

Changzhi, Shanxi, China

RECRUITING

Linfen Central Hospital

Linfen, Shanxi, China

RECRUITING

...and 2 more locations

Outcomes

Primary Outcomes

Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)

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.