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
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.
Обзор исследования
Статус
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jie Liang, MD, PhD
- Номер телефона: 029-84771535
- Электронная почта: liangjie@fmmu.edu.cn
Места учебы
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BeijingBeijing
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Beijing, BeijingBeijing, Китай, 100730
- Рекрутинг
- Peking Union Medical College Hospital
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Контакт:
- Yue Li, Professor
- Номер телефона: 010-65296114
- Электронная почта: koujie@pumch.ac.cn
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Liaoning
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Shenyang, Liaoning, Китай, 110004
- Рекрутинг
- Shengjing Hospital of China Medical University
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Контакт:
- Feng Tian, Professor
- Номер телефона: 024-83955555
- Электронная почта: xux@sj-hospital.org
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Qinghai
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Xining, Qinghai, Китай, 810001
- Рекрутинг
- Affiliated Hospital of Qinghai University
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Контакт:
- Qi An, Professor
- Номер телефона: 0971-6111999
- Электронная почта: qdfyrsk@126.com
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Shaanxi
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Xi'an, Shaanxi, Китай, 710004
- Рекрутинг
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Контакт:
- Haitao Shi, Professor
- Номер телефона: 029-87679323
- Электронная почта: dieryiyuan@163.com
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Xi'an, Shaanxi, Китай, 710054
- Рекрутинг
- Air Force 986 Hospital
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Контакт:
- Jun Wang, Professor
- Номер телефона: 029-84756114
- Электронная почта: webmaster@fmmu.edu.cn
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Китай, 200127
- Рекрутинг
- Renji Hospital, Shanghai Jiao Tong University School of Medicine
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Контакт:
- Jun Shen, Professor
- Номер телефона: 021-58752345
- Электронная почта: xck@renji.com
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Shanghai, Shanghai Municipality, Китай, 200433
- Рекрутинг
- Changhai Hospital, Naval Medical University
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Контакт:
- Zixuan 200433 He, Professor
- Номер телефона: 021-31166666
- Электронная почта: administrator@cnkang.com
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Shanghai, Shanghai Municipality, Китай, 200025
- Рекрутинг
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Контакт:
- Yubei Gu, Professor
- Номер телефона: 021-34186000
- Электронная почта: rjhfbgs@rjh.com.cn
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Shanxi
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Changzhi, Shanxi, Китай, 046000
- Рекрутинг
- Heping Hospital affiliated to Changzhi Medical College
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Контакт:
- Lili Guo, Professor
- Номер телефона: 0355-3128457
- Электронная почта: guest@tyhpyy.com
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Linfen, Shanxi, Китай, 041000
- Рекрутинг
- Linfen Central Hospital
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Контакт:
- Huiling Su, Professor
- Номер телефона: 0357-3333120
- Электронная почта: linfench.@163.com
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Yuncheng, Shanxi, Китай, 044000
- Рекрутинг
- Yuncheng Central Hospital
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Контакт:
- Li Zhang, Professor
- Номер телефона: 0359-6399222
- Электронная почта: ycchcgk@163.com
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Xinjiang
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Ürümqi, Xinjiang, Китай, 830054
- Рекрутинг
- The First Affiliated Hospital of Xinjiang Medical University
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Контакт:
- Hongliang Gao, Professor
- Номер телефона: 0991-4362930
- Электронная почта: 15099109392@163.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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. |
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.
Другие имена:
standard bowel preparation education |
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Активный компаратор: 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. |
standard bowel preparation education |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
Временное ограничение: Periprocedural (during colonoscopy)
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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)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Adequate Bowel Preparation Rate
Временное ограничение: Periprocedural (during colonoscopy)
|
Proportion of patients with adequate bowel preparation, defined as total BBPS score ≥ 6. |
Periprocedural (during colonoscopy)
|
|
Excellent Bowel Preparation Rate
Временное ограничение: Periprocedural (during colonoscopy)
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Proportion of patients with excellent bowel preparation, defined as total BBPS score ≥ 8. |
Periprocedural (during colonoscopy)
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Cecal Intubation Rate
Временное ограничение: Periprocedural (during colonoscopy)
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Proportion of patients in whom the cecum is successfully intubated during colonoscopy. |
Periprocedural (during colonoscopy)
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Cecal Intubation Time
Временное ограничение: Periprocedural (during colonoscopy)
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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)
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Bowel Preparation Compliance Rate
Временное ограничение: After bowel preparation and before colonoscopy (assessed on the day of procedure)
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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)
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Patient Experience - Anxiety, Tolerance, Satisfaction, Willingness to Repeat
Временное ограничение: After bowel preparation and before colonoscopy (assessed on the day of procedure)
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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)
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Incidence of Adverse Events
Временное ограничение: During bowel preparation and up to 7 days post-colonoscopy
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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
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Bowel Preparation Knowledge Score
Временное ограничение: After bowel preparation and before colonoscopy (assessed on the day of procedure)
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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)
|
Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KY20262099-F-1
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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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