Inflammatory Bowel DiseasesNCT07582731
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
A study testing Disease Subtype-Based Active Video Education and standard bowel preparation education in people with Inflammatory Bowel Diseases, run by Jie Liang at 12 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Disease Subtype-Based Active Video Education and standard bowel preparation education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 12 sitesChina
- Study dates
- 1 Jun 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, BeijingBeijing, 100730
Yue Li, Professor, 010-65296114, koujie@pumch.ac.cn
- Recruiting
Heping Hospital affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000
Lili Guo, Professor, 0355-3128457, guest@tyhpyy.com
- Recruiting
Linfen Central Hospital
Linfen, Shanxi, 041000
Huiling Su, Professor, 0357-3333120, linfench.@163.com
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Yubei Gu, Professor, 021-34186000, rjhfbgs@rjh.com.cn
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Jun Shen, Professor, 021-58752345, xck@renji.com
- Recruiting
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, 200433
Zixuan 200433 He, Professor, 021-31166666, administrator@cnkang.com
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Feng Tian, Professor, 024-83955555, xux@sj-hospital.org
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Hongliang Gao, Professor, 0991-4362930, 15099109392@163.com
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Haitao Shi, Professor, 029-87679323, dieryiyuan@163.com
- Recruiting
Air Force 986 Hospital
Xi'an, Shaanxi, 710054
Jun Wang, Professor, 029-84756114, webmaster@fmmu.edu.cn
- Recruiting
Affiliated Hospital of Qinghai University
Xining, Qinghai, 810001
Qi An, Professor, 0971-6111999, qdfyrsk@126.com
- Recruiting
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000
Li Zhang, Professor, 0359-6399222, ycchcgk@163.com
About this study
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.
Read the detailed description
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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Disease Subtype-Based Active Video Education, standard bowel preparation education
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease Subtype-Based Active Video EducationBehavioural
Also called WeChat-Based Personalized IBD 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.
standard bowel preparation educationBehavioural
standard bowel preparation education
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Active Video Education Group) | Experimental | 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. Receives: Behavioral: Disease Subtype-Based Active Video Education; Behavioral: standard bowel preparation education |
| Control Group (Conventional Education Group) | Active comparator | 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. Receives: Behavioral: standard bowel preparation education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
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.
Measured: Periprocedural (during colonoscopy)
Secondary outcomes (8)
Adequate Bowel Preparation Rate
Proportion of patients with adequate bowel preparation, defined as total BBPS score ≥ 6.
Measured: Periprocedural (during colonoscopy)
Excellent Bowel Preparation Rate
Proportion of patients with excellent bowel preparation, defined as total BBPS score ≥ 8.
Measured: Periprocedural (during colonoscopy)
Cecal Intubation Rate
Proportion of patients in whom the cecum is successfully intubated during colonoscopy.
Measured: Periprocedural (during colonoscopy)
Cecal Intubation Time
Time (in seconds) required to reach and intubate the cecum, measured from the time the colonoscope is inserted until cecal intubation is confirmed.
Measured: Periprocedural (during colonoscopy)
Bowel Preparation Compliance Rate
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).
Measured: After bowel preparation and before colonoscopy (assessed on the day of procedure)
Patient Experience - Anxiety, Tolerance, Satisfaction, Willingness to Repeat
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.
Measured: After bowel preparation and before colonoscopy (assessed on the day of procedure)
Incidence of Adverse Events
Number and proportion of patients experiencing adverse events related to bowel preparation, including nausea, vomiting, abdominal pain, bloating, and electrolyte abnormalities.
Measured: During bowel preparation and up to 7 days post-colonoscopy
Bowel Preparation Knowledge Score
Patient knowledge about bowel preparation assessed using a 0-10 point questionnaire, with higher scores indicating better knowledge.
Measured: After bowel preparation and before colonoscopy (assessed on the day of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jun 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This multi-center trial (13 centers) uses center-stratified randomization with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Liang
- Sponsor type
- University, hospital or other
- Collaborators
- Xijing Hospital of Digestive Diseases, Peking Union Medical College Hospital, Shengjing Hospital, RenJi Hospital, Changhai Hospital, First Affiliated Hospital of Xinjiang Medical University, Affiliated Hospital of Qinghai University, Second Affiliated Hospital of Xi'an Jiaotong University, Air Force 986 Hospital, Shanxi Yuncheng Central Hospital, Ruijin Hospital, Changzhi Medical College, Linfen Central Hospital
- Responsible party
- Sponsor-investigator, Jie Liang, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582731
- Sponsor's protocol ID
- KY20262099-F-1
- Status last verified
- Sep 2026
- First submitted
- 6 May 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07582731
- Acronym / sponsor ID
- KY20262099-F-1
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jie LiangUniversity, hospital or other
- Collaborators
- Xijing Hospital of Digestive Diseases, Peking Union Medical College Hospital, Shengjing Hospital, RenJi Hospital, Changhai Hospital, First Affiliated Hospital of Xinjiang Medical University, Affiliated Hospital of Qinghai University, Second Affiliated Hospital of Xi'an Jiaotong University, Air Force 986 Hospital, Shanxi Yuncheng Central Hospital, Ruijin Hospital, Changzhi Medical College, Linfen Central Hospital
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This multi-center trial (13 centers) uses center-stratified randomization with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Active Video Education Group) | Experimental | Behavioral: Disease Subtype-Based Active Video Education, Behavioral: standard bowel preparation educationPatients 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. |
| Control Group (Conventional Education Group) | Active comparator | Behavioral: standard bowel preparation educationPatients receive only standard bowel preparation education, including unified written instructions and a 10-minute verbal explanation, with no additional video education. Sample size: 300. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disease Subtype-Based Active Video EducationAlso: WeChat-Based Personalized IBD Video EducationA 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. | Behavioural | Intervention Group (Active Video Education Group) |
| standard bowel preparation educationstandard bowel preparation education | Behavioural | Control Group (Conventional Education Group), Intervention Group (Active Video Education Group) |
Primary outcome
Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS)
Time frame: 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.
8 secondary outcomes
Adequate Bowel Preparation Rate
Time frame: Periprocedural (during colonoscopy)
Excellent Bowel Preparation Rate
Time frame: Periprocedural (during colonoscopy)
Cecal Intubation Rate
Time frame: Periprocedural (during colonoscopy)
Cecal Intubation Time
Time frame: Periprocedural (during colonoscopy)
Bowel Preparation Compliance Rate
Time frame: After bowel preparation and before colonoscopy (assessed on the day of procedure)
Patient Experience - Anxiety, Tolerance, Satisfaction, Willingness to Repeat
Time frame: After bowel preparation and before colonoscopy (assessed on the day of procedure)
Incidence of Adverse Events
Time frame: During bowel preparation and up to 7 days post-colonoscopy
Bowel Preparation Knowledge Score
Time frame: After bowel preparation and before colonoscopy (assessed on the day of procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disease Subtype-Based Active Video Education and standard bowel preparation education in people with Inflammatory Bowel Diseases, run by Jie Liang at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Liang, MD, PhD (029-84771535, liangjie@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Preparation Quality (Boston Bowel Preparation Scale, BBPS) (time frame: Periprocedural (during colonoscopy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.