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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. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

600

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Andre navne:
  • WeChat-Based Personalized IBD Video Education
Adfærdsmæssigt: standard bowel preparation education

standard bowel preparation education
Aktiv 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.
Adfærdsmæssigt: standard bowel preparation education

standard bowel preparation education

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adequate Bowel Preparation Rate
Tidsramme: Periprocedural (during colonoscopy)

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

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

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jie Liang

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY20262099-F-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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