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| Name | Class |
|---|---|
| Xijing Hospital of Digestive Diseases | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Shengjing Hospital | OTHER |
| RenJi Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (Active Video Education Group) | Experimental | 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. |
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| Control Group (Conventional Education Group) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disease Subtype-Based Active Video Education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Periprocedural (during colonoscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| Adequate Bowel Preparation Rate | Proportion of patients with adequate bowel preparation, defined as total BBPS score ≥ 6. | Periprocedural (during colonoscopy) |
| Excellent Bowel Preparation Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Liang, MD, PhD | Contact | 029-84771535 | liangjie@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | BeijingBeijing | 100730 | China |
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.
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| OTHER |
| Changhai hospital of Navy Medical University | UNKNOWN |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Affiliated Hospital of Qinghai University | OTHER |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Air Force 986 Hospital | OTHER |
| Shanxi Yuncheng Central Hospital | UNKNOWN |
| Ruijin Hospital | OTHER |
| Changzhi Medical College | OTHER |
| The Central Hospital of Linfen | UNKNOWN |
This multi-center trial (13 centers) uses center-stratified randomization with a 1:1 allocation ratio.
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Outcome assessors (endoscopists evaluating bowel preparation quality and research staff collecting data) will be blinded to participants' group assignment to minimize assessment bias.
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| standard bowel preparation education | Behavioral | standard bowel preparation education |
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Proportion of patients with excellent bowel preparation, defined as total BBPS score ≥ 8.
| Periprocedural (during colonoscopy) |
| Cecal Intubation Rate | Proportion of patients in whom the cecum is successfully intubated during colonoscopy. | Periprocedural (during colonoscopy) |
| Cecal Intubation Time | 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 | 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 | 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 | 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 | 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) |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
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| Affiliated Hospital of Qinghai University | Xining | Qinghai | 810001 | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710004 | China |
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| Air Force 986 Hospital | Xi'an | Shaanxi | 710054 | China |
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| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
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| Changhai Hospital, Naval Medical University | Shanghai | Shanghai Municipality | 200433 | China |
| Heping Hospital affiliated to Changzhi Medical College | Changzhi | Shanxi | 046000 | China |
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| Linfen Central Hospital | Linfen | Shanxi | 041000 | China |
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| Yuncheng Central Hospital | Yuncheng | Shanxi | 044000 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | China |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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