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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое standard bowel preparation education
  standard bowel preparation education

Первичные конечные точки

• Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS) [Срок оценки: Periprocedural (during colonoscopy)]

Вторичные конечные точки (8)

• Adequate Bowel Preparation Rate [Срок оценки: Periprocedural (during colonoscopy)]
• Excellent Bowel Preparation Rate [Срок оценки: Periprocedural (during colonoscopy)]
• Cecal Intubation Rate [Срок оценки: Periprocedural (during colonoscopy)]
• Cecal Intubation Time [Срок оценки: Periprocedural (during colonoscopy)]
• Bowel Preparation Compliance Rate [Срок оценки: After bowel preparation and before colonoscopy (assessed on the day of procedure)]
• Patient Experience - Anxiety, Tolerance, Satisfaction, Willingness to Repeat [Срок оценки: After bowel preparation and before colonoscopy (assessed on the day of procedure)]
• Incidence of Adverse Events [Срок оценки: During bowel preparation and up to 7 days post-colonoscopy]
• Bowel Preparation Knowledge Score [Срок оценки: After bowel preparation and before colonoscopy (assessed on the day of procedure)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 12 центров

• Peking Union Medical College Hospital — Пекин
• Shengjing Hospital of China Medical University — Шэньян
• Affiliated Hospital of Qinghai University — Xining
• The Second Affiliated Hospital of Xi'an Jiaotong University — Сиань
• Air Force 986 Hospital — Сиань
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай
• Changhai Hospital, Naval Medical University — Шанхай
• … и ещё 4 центра

Идентификаторы

NCT: NCT07582731 · KY20262099-F-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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