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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jie Liang, MD, PhD
- Número de teléfono: 029-84771535
- Correo electrónico: liangjie@fmmu.edu.cn
Ubicaciones de estudio
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BeijingBeijing
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Beijing, BeijingBeijing, Porcelana, 100730
- Reclutamiento
- Peking Union Medical College Hospital
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Contacto:
- Yue Li, Professor
- Número de teléfono: 010-65296114
- Correo electrónico: koujie@pumch.ac.cn
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Liaoning
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Shenyang, Liaoning, Porcelana, 110004
- Reclutamiento
- Shengjing Hospital of China Medical University
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Contacto:
- Feng Tian, Professor
- Número de teléfono: 024-83955555
- Correo electrónico: xux@sj-hospital.org
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Qinghai
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Xining, Qinghai, Porcelana, 810001
- Reclutamiento
- Affiliated Hospital of Qinghai University
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Contacto:
- Qi An, Professor
- Número de teléfono: 0971-6111999
- Correo electrónico: qdfyrsk@126.com
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710004
- Reclutamiento
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Contacto:
- Haitao Shi, Professor
- Número de teléfono: 029-87679323
- Correo electrónico: dieryiyuan@163.com
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Xi'an, Shaanxi, Porcelana, 710054
- Reclutamiento
- Air Force 986 Hospital
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Contacto:
- Jun Wang, Professor
- Número de teléfono: 029-84756114
- Correo electrónico: webmaster@fmmu.edu.cn
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200127
- Reclutamiento
- Renji Hospital, Shanghai Jiao Tong University School of Medicine
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Contacto:
- Jun Shen, Professor
- Número de teléfono: 021-58752345
- Correo electrónico: xck@renji.com
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Shanghai, Shanghai Municipality, Porcelana, 200433
- Reclutamiento
- Changhai Hospital, Naval Medical University
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Contacto:
- Zixuan 200433 He, Professor
- Número de teléfono: 021-31166666
- Correo electrónico: administrator@cnkang.com
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Shanghai, Shanghai Municipality, Porcelana, 200025
- Reclutamiento
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Contacto:
- Yubei Gu, Professor
- Número de teléfono: 021-34186000
- Correo electrónico: rjhfbgs@rjh.com.cn
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Shanxi
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Changzhi, Shanxi, Porcelana, 046000
- Reclutamiento
- Heping Hospital affiliated to Changzhi Medical College
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Contacto:
- Lili Guo, Professor
- Número de teléfono: 0355-3128457
- Correo electrónico: guest@tyhpyy.com
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Linfen, Shanxi, Porcelana, 041000
- Reclutamiento
- Linfen Central Hospital
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Contacto:
- Huiling Su, Professor
- Número de teléfono: 0357-3333120
- Correo electrónico: linfench.@163.com
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Yuncheng, Shanxi, Porcelana, 044000
- Reclutamiento
- Yuncheng Central Hospital
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Contacto:
- Li Zhang, Professor
- Número de teléfono: 0359-6399222
- Correo electrónico: ycchcgk@163.com
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Xinjiang
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Ürümqi, Xinjiang, Porcelana, 830054
- Reclutamiento
- The First Affiliated Hospital of Xinjiang Medical University
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Contacto:
- Hongliang Gao, Professor
- Número de teléfono: 0991-4362930
- Correo electrónico: 15099109392@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
Otros nombres:
standard bowel preparation education |
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Comparador activo: 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adequate Bowel Preparation Rate
Periodo de tiempo: Periprocedural (during colonoscopy)
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Proportion of patients with adequate bowel preparation, defined as total BBPS score ≥ 6. |
Periprocedural (during colonoscopy)
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Excellent Bowel Preparation Rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY20262099-F-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
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