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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jie Liang, MD, PhD
- 電話番号：029-84771535
- メール：liangjie@fmmu.edu.cn
研究場所
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BeijingBeijing
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Beijing、BeijingBeijing、中国、100730
- 募集
- Peking Union Medical College Hospital
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コンタクト：
- Yue Li, Professor
- 電話番号：010-65296114
- メール：koujie@pumch.ac.cn
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Liaoning
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Shenyang、Liaoning、中国、110004
- 募集
- Shengjing Hospital of China Medical University
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コンタクト：
- Feng Tian, Professor
- 電話番号：024-83955555
- メール：xux@sj-hospital.org
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Qinghai
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Xining、Qinghai、中国、810001
- 募集
- Affiliated Hospital of Qinghai University
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コンタクト：
- Qi An, Professor
- 電話番号：0971-6111999
- メール：qdfyrsk@126.com
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Shaanxi
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Xi'an、Shaanxi、中国、710004
- 募集
- The Second Affiliated Hospital of Xi'an Jiaotong University
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コンタクト：
- Haitao Shi, Professor
- 電話番号：029-87679323
- メール：dieryiyuan@163.com
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Xi'an、Shaanxi、中国、710054
- 募集
- Air Force 986 Hospital
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コンタクト：
- Jun Wang, Professor
- 電話番号：029-84756114
- メール：webmaster@fmmu.edu.cn
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200127
- 募集
- Renji Hospital, Shanghai Jiao Tong University School of Medicine
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コンタクト：
- Jun Shen, Professor
- 電話番号：021-58752345
- メール：xck@renji.com
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Shanghai、Shanghai Municipality、中国、200433
- 募集
- Changhai Hospital, Naval Medical University
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コンタクト：
- Zixuan 200433 He, Professor
- 電話番号：021-31166666
- メール：administrator@cnkang.com
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Shanghai、Shanghai Municipality、中国、200025
- 募集
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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コンタクト：
- Yubei Gu, Professor
- 電話番号：021-34186000
- メール：rjhfbgs@rjh.com.cn
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Shanxi
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Changzhi、Shanxi、中国、046000
- 募集
- Heping Hospital affiliated to Changzhi Medical College
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コンタクト：
- Lili Guo, Professor
- 電話番号：0355-3128457
- メール：guest@tyhpyy.com
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Linfen、Shanxi、中国、041000
- 募集
- Linfen Central Hospital
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コンタクト：
- Huiling Su, Professor
- 電話番号：0357-3333120
- メール：linfench.@163.com
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Yuncheng、Shanxi、中国、044000
- 募集
- Yuncheng Central Hospital
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コンタクト：
- Li Zhang, Professor
- 電話番号：0359-6399222
- メール：ycchcgk@163.com
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Xinjiang
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Ürümqi、Xinjiang、中国、830054
- 募集
- The First Affiliated Hospital of Xinjiang Medical University
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コンタクト：
- Hongliang Gao, Professor
- 電話番号：0991-4362930
- メール：15099109392@163.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
standard bowel preparation education |
|
アクティブコンパレータ：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adequate Bowel Preparation Rate
時間枠：Periprocedural (during colonoscopy)
|
Proportion of patients with adequate bowel preparation, defined as total BBPS score ≥ 6. |
Periprocedural (during colonoscopy)
|
|
Excellent Bowel Preparation Rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
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Patient Experience - Anxiety, Tolerance, Satisfaction, Willingness to Repeat
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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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