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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

13. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

600

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Andere Namen:
  • WeChat-Based Personalized IBD Video Education
Verhalten: standard bowel preparation education
standard bowel preparation education
Aktiver Komparator: 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.
Verhalten: standard bowel preparation education
standard bowel preparation education

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adequate Bowel Preparation Rate
Zeitfenster: Periprocedural (during colonoscopy)
Proportion of patients with adequate bowel preparation, defined as total BBPS score ≥ 6.
Periprocedural (during colonoscopy)
Excellent Bowel Preparation Rate
Zeitfenster: Periprocedural (during colonoscopy)
Proportion of patients with excellent bowel preparation, defined as total BBPS score ≥ 8.
Periprocedural (during colonoscopy)
Cecal Intubation Rate
Zeitfenster: Periprocedural (during colonoscopy)
Proportion of patients in whom the cecum is successfully intubated during colonoscopy.
Periprocedural (during colonoscopy)
Cecal Intubation Time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Jie Liang

Mitarbeiter

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
Changhai hospital of Navy Medical University
Shanxi Yuncheng Central Hospital
The Central Hospital of Linfen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juni 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

6. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KY20262099-F-1

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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