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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jie Liang, MD, PhD
- 전화번호: 029-84771535
- 이메일: liangjie@fmmu.edu.cn
연구 장소
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BeijingBeijing
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Beijing, BeijingBeijing, 중국, 100730
- 모병
- Peking Union Medical College Hospital
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연락하다:
- Yue Li, Professor
- 전화번호: 010-65296114
- 이메일: koujie@pumch.ac.cn
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Liaoning
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Shenyang, Liaoning, 중국, 110004
- 모병
- Shengjing Hospital of China Medical University
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연락하다:
- Feng Tian, Professor
- 전화번호: 024-83955555
- 이메일: xux@sj-hospital.org
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Qinghai
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Xining, Qinghai, 중국, 810001
- 모병
- Affiliated Hospital of Qinghai University
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연락하다:
- Qi An, Professor
- 전화번호: 0971-6111999
- 이메일: qdfyrsk@126.com
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Shaanxi
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Xi'an, Shaanxi, 중국, 710004
- 모병
- The Second Affiliated Hospital of Xi'an Jiaotong University
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연락하다:
- Haitao Shi, Professor
- 전화번호: 029-87679323
- 이메일: dieryiyuan@163.com
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Xi'an, Shaanxi, 중국, 710054
- 모병
- Air Force 986 Hospital
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연락하다:
- Jun Wang, Professor
- 전화번호: 029-84756114
- 이메일: webmaster@fmmu.edu.cn
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200127
- 모병
- Renji Hospital, Shanghai Jiao Tong University School of Medicine
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연락하다:
- Jun Shen, Professor
- 전화번호: 021-58752345
- 이메일: xck@renji.com
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Shanghai, Shanghai Municipality, 중국, 200433
- 모병
- Changhai Hospital, Naval Medical University
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연락하다:
- Zixuan 200433 He, Professor
- 전화번호: 021-31166666
- 이메일: administrator@cnkang.com
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Shanghai, Shanghai Municipality, 중국, 200025
- 모병
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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연락하다:
- Yubei Gu, Professor
- 전화번호: 021-34186000
- 이메일: rjhfbgs@rjh.com.cn
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Shanxi
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Changzhi, Shanxi, 중국, 046000
- 모병
- Heping Hospital affiliated to Changzhi Medical College
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연락하다:
- Lili Guo, Professor
- 전화번호: 0355-3128457
- 이메일: guest@tyhpyy.com
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Linfen, Shanxi, 중국, 041000
- 모병
- Linfen Central Hospital
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연락하다:
- Huiling Su, Professor
- 전화번호: 0357-3333120
- 이메일: linfench.@163.com
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Yuncheng, Shanxi, 중국, 044000
- 모병
- Yuncheng Central Hospital
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연락하다:
- Li Zhang, Professor
- 전화번호: 0359-6399222
- 이메일: ycchcgk@163.com
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Xinjiang
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Ürümqi, Xinjiang, 중국, 830054
- 모병
- The First Affiliated Hospital of Xinjiang Medical University
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연락하다:
- Hongliang Gao, Professor
- 전화번호: 0991-4362930
- 이메일: 15099109392@163.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
standard bowel preparation education |
|
활성 비교기: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adequate Bowel Preparation Rate
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
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