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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

17 de setembro de 2026 atualizado por: Jie Liang

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

600

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • BeijingBeijing
      • Beijing, BeijingBeijing, China, 100730
        • Recrutamento
        • Peking Union Medical College Hospital
        • Contato:
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recrutamento
        • Shengjing Hospital of China Medical University
        • Contato:
    • Qinghai
      • Xining, Qinghai, China, 810001
        • Recrutamento
        • Affiliated Hospital of Qinghai University
        • Contato:
          • Qi An, Professor
          • Número de telefone: 0971-6111999
          • E-mail: qdfyrsk@126.com
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Recrutamento
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contato:
      • Xi'an, Shaanxi, China, 710054
        • Recrutamento
        • Air Force 986 Hospital
        • Contato:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Recrutamento
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contato:
          • Jun Shen, Professor
          • Número de telefone: 021-58752345
          • E-mail: xck@renji.com
      • Shanghai, Shanghai Municipality, China, 200433
        • Recrutamento
        • Changhai Hospital, Naval Medical University
        • Contato:
      • Shanghai, Shanghai Municipality, China, 200025
        • Recrutamento
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contato:
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Recrutamento
        • Heping Hospital affiliated to Changzhi Medical College
        • Contato:
          • Lili Guo, Professor
          • Número de telefone: 0355-3128457
          • E-mail: guest@tyhpyy.com
      • Linfen, Shanxi, China, 041000
        • Recrutamento
        • Linfen Central Hospital
        • Contato:
      • Yuncheng, Shanxi, China, 044000
        • Recrutamento
        • Yuncheng Central Hospital
        • Contato:
          • Li Zhang, Professor
          • Número de telefone: 0359-6399222
          • E-mail: ycchcgk@163.com
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • Recrutamento
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Age between 18 and 75 years, inclusive.
  2. Confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's disease (CD) according to standard clinical guidelines.
  3. Scheduled for elective colonoscopy for IBD monitoring or disease activity assessment.
  4. Able to understand written and verbal instructions and to use a smartphone to view video education materials.
  5. Voluntary participation with written informed consent.

Exclusion Criteria:

  1. Absolute contraindications to colonoscopy, including acute gastrointestinal perforation, fulminant colitis, toxic megacolon, or hemodynamic instability.
  2. History of total or subtotal colectomy.
  3. Acute or chronic intestinal obstruction.
  4. Severe cardiac, pulmonary, hepatic, or renal insufficiency (eGFR <30 mL/min/1.73m², NYHA class III/IV).
  5. Severe psychiatric or cognitive impairment that prevents understanding of the study requirements.
  6. Inability or unwillingness to provide written informed consent.
  7. Pregnant or breastfeeding women.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: 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 protocols. The video is delivered via WeChat link.

Outros nomes:
  • WeChat-Based Personalized IBD Video Education
Comportamental: standard bowel preparation education

standard bowel preparation education
Comparador Ativo: 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.
Comportamental: standard bowel preparation education

standard bowel preparation education

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
Prazo: 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.
Periprocedural (during colonoscopy)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Adequate Bowel Preparation Rate
Prazo: Periprocedural (during colonoscopy)

Proportion of patients with adequate bowel preparation, defined as total BBPS score ≥ 6.
Periprocedural (during colonoscopy)
Excellent Bowel Preparation Rate
Prazo: Periprocedural (during colonoscopy)

Proportion of patients with excellent bowel preparation, defined as total BBPS score ≥ 8.
Periprocedural (during colonoscopy)
Cecal Intubation Rate
Prazo: Periprocedural (during colonoscopy)

Proportion of patients in whom the cecum is successfully intubated during colonoscopy.
Periprocedural (during colonoscopy)
Cecal Intubation Time
Prazo: Periprocedural (during colonoscopy)

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)
Bowel Preparation Compliance Rate
Prazo: After bowel preparation and before colonoscopy (assessed on the day of procedure)

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)
Patient Experience - Anxiety, Tolerance, Satisfaction, Willingness to Repeat
Prazo: After bowel preparation and before colonoscopy (assessed on the day of procedure)

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)
Incidence of Adverse Events
Prazo: During bowel preparation and up to 7 days post-colonoscopy

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
Bowel Preparation Knowledge Score
Prazo: After bowel preparation and before colonoscopy (assessed on the day of procedure)

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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Jie Liang

Colaboradores

Changhai Hospital
Peking Union Medical College Hospital
RenJi Hospital
Shengjing Hospital
Xijing Hospital of Digestive Diseases
Ruijin Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
First Affiliated Hospital of Xinjiang Medical University
Changzhi Medical College
Affiliated Hospital of Qinghai University
Air Force 986 Hospital
Shanxi Yuncheng Central Hospital
Linfen Central Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de outubro de 2026

Conclusão do estudo (Estimado)

1 de outubro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

6 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2026

Primeira postagem (Real)

13 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • KY20262099-F-1

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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