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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 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

600

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • BeijingBeijing
      • Beijing, BeijingBeijing, Cina, 100730
        • Reclutamento
        • Peking Union Medical College Hospital
        • Contatto:
    • Liaoning
      • Shenyang, Liaoning, Cina, 110004
        • Reclutamento
        • Shengjing Hospital of China Medical University
        • Contatto:
    • Qinghai
      • Xining, Qinghai, Cina, 810001
        • Reclutamento
        • Affiliated Hospital of Qinghai University
        • Contatto:
    • Shaanxi
      • Xi'an, Shaanxi, Cina, 710004
        • Reclutamento
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contatto:
      • Xi'an, Shaanxi, Cina, 710054
        • Reclutamento
        • Air Force 986 Hospital
        • Contatto:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200127
        • Reclutamento
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contatto:
          • Jun Shen, Professor
          • Numero di telefono: 021-58752345
          • Email: xck@renji.com
      • Shanghai, Shanghai Municipality, Cina, 200433
        • Reclutamento
        • Changhai Hospital, Naval Medical University
        • Contatto:
      • Shanghai, Shanghai Municipality, Cina, 200025
        • Reclutamento
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contatto:
    • Shanxi
      • Changzhi, Shanxi, Cina, 046000
        • Reclutamento
        • Heping Hospital affiliated to Changzhi Medical College
        • Contatto:
      • Linfen, Shanxi, Cina, 041000
        • Reclutamento
        • Linfen Central Hospital
        • Contatto:
      • Yuncheng, Shanxi, Cina, 044000
        • Reclutamento
        • Yuncheng Central Hospital
        • Contatto:
          • Li Zhang, Professor
          • Numero di telefono: 0359-6399222
          • Email: ycchcgk@163.com
    • Xinjiang
      • Ürümqi, Xinjiang, Cina, 830054
        • Reclutamento
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.

Altri nomi:
  • WeChat-Based Personalized IBD Video Education
Comportamentale: standard bowel preparation education

standard bowel preparation education
Comparatore attivo: 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.
Comportamentale: standard bowel preparation education

standard bowel preparation education

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adequate Bowel Preparation Rate
Lasso di tempo: Periprocedural (during colonoscopy)

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

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

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Jie Liang

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 ottobre 2026

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2026

Primo Inserito (Effettivo)

13 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KY20262099-F-1

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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