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临床试验/NCT07582731
NCT07582731尚未招募不适用

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 Liang12 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
600
试验地点
12

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

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)

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.

干预措施: standard bowel preparation education (Behavioral)

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.

干预措施: Disease Subtype-Based Active Video Education (Behavioral)

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.

干预措施: standard bowel preparation education (Behavioral)

研究者

发起方
Jie Liang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jie Liang

Professor

Xijing Hospital of Digestive Diseases

研究点 (12)

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