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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 12
- 主要终点
- Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors (endoscopists evaluating bowel preparation quality and research staff collecting data) will be blinded to participants' group assignment to minimize assessment bias.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: standard bowel preparation education (Behavioral)
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.
干预措施: Disease Subtype-Based Active Video Education (Behavioral)
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.
干预措施: standard bowel preparation education (Behavioral)
结局指标
主要结局
Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
时间窗: 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.
次要结局
- Adequate Bowel Preparation Rate(Periprocedural (during colonoscopy))
- Excellent Bowel Preparation Rate(Periprocedural (during colonoscopy))
- Cecal Intubation Rate(Periprocedural (during colonoscopy))
- Cecal Intubation Time(Periprocedural (during colonoscopy))
- Bowel Preparation Compliance Rate(After bowel preparation and before colonoscopy (assessed on the day of procedure))
- Patient Experience - Anxiety, Tolerance, Satisfaction, Willingness to Repeat(After bowel preparation and before colonoscopy (assessed on the day of procedure))
- Incidence of Adverse Events(During bowel preparation and up to 7 days post-colonoscopy)
- Bowel Preparation Knowledge Score(After bowel preparation and before colonoscopy (assessed on the day of procedure))
研究者
Jie Liang
Professor
Xijing Hospital of Digestive Diseases