Inflammatory Bowel DiseasesNCT04948723
Vaccination Practices for Inflammatory Bowel Disease Patients in China With Gastroenterologists
An observational study of Inflammatory Bowel Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The aim of the current study was to evaluate the knowledge of Chinese gastroenterologists on vaccinating patients with IBD under the assistance of Chinese Crohn's \& Colitis Foundation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 307 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: An email with a quick response code (QRC) was sent to CCCF-affiliated gastroenterologists specializing in IBD between July 2017 and August 2017
Who may be able to join
- gastroenterologists were members of tertiary hospitals
Who cannot join
- pediatricians were excluded, as were retired gastroenterologists and those currently in training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insufficient Awareness and Vaccination Practices for Inflammatory Bowel Disease Patients in China: A Multi-center Survey of Chinese Gastroenterologists
The aim of the current study was to evaluate the knowledge of Chinese gastroenterologists on vaccinating patients with IBD under the assistance of Chinese Crohn's \& Colitis Foundation. The Chinese Crohn's \& Colitis Foundation (CCCF) is the first nonprofit,volunteer-driven foundation specifically for patients with IBD in China.It has been joined by IBD specialists at various hospitals in China.
Read the detailed description
The questionnaire contained questions regarding the respondents'information, including their gender, years in practice, clinical specialty,and source of knowledge on immunization practices. The questionnaire mainly contained three sections: knowledge of vaccinations for hepatitis A virus (HAV), HBV, and varicella; current vaccination practices for the IBD group; and reasons for not recommending these vaccinations to patients with IBD. The questionnaire composed of 13 items specifically on the three vaccinations mentioned above for immunosuppressed patients with IBD. All questions were conducted based on recognized guidelines and were reviewed by 18 IBD experts. The questionnaire captured the frequency with which the respondents assessed patients with IBD for anti-HAV/hepatitis B surface antigen (HBsAg), hepatitis B core antibody, and hepatitis B surface antibody/ anti-HAV levels, and acquired infection and immunization histories. Whether the respondents recommended these three vaccines to the IBD group before treatment was also elicited.
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- inflammatory bowel diseases， vaccination
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
vaccination practices
The questionnaire mainly contained three sections: knowledge of vaccinations for hepatitis A virus (HAV), HBV, and varicella; current vaccination practices for the IBD group; and reasons for not recommending these vaccinations to patients with IBD. The questionnaire captured the frequency with which the respondents assessed patients with IBD for anti-HAV/hepatitis B surface antigen (HBsAg), hepatitis B core antibody, and hepatitis B surface antibody/ anti-HAV levels, and acquired infection and immunization histories.
Measured: between July 2017 and August 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Jul 2017
- Primary completion1 Jul 2017
- Study completion1 Aug 2017
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Ruijin Hospital, Zhujiang Hospital, Army Medical University, China, Peking Union Medical College Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Affiliated Hospital of Nanjing University of Chinese Medicine, Lishui Municipal Central Hospital, the Fifth Affiliated Hospital of Wenzhou Medical University, Shangyu People's Hospital of Shaoxing City
- Responsible party
- Sponsor
- Investigators
- Yan Chen, Study director, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948723
- Sponsor's protocol ID
- 2020-089
- Status last verified
- Jul 2021
- First submitted
- 17 Jun 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insufficient Awareness and Vaccination Practices for Inflammatory Bowel Disease Patients in China: A Multi-center Survey of Chinese Gastroenterologists
- ClinicalTrials.gov ID
- NCT04948723
- Acronym / sponsor ID
- 2020-089
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- inflammatory bowel diseases， vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Ruijin Hospital, Zhujiang Hospital, Army Medical University, China, Peking Union Medical College Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Affiliated Hospital of Nanjing University of Chinese Medicine, Lishui Municipal Central Hospital, the Fifth Affiliated Hospital of Wenzhou Medical University, Shangyu People's Hospital of Shaoxing City
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 2 Jul 2021 (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.
The aim of the current study was to evaluate the knowledge of Chinese gastroenterologists on vaccinating patients with IBD under the assistance of Chinese Crohn's \& Colitis Foundation. The Chinese Crohn's \& Colitis Foundation (CCCF) is the first nonprofit,volunteer-driven foundation specifically for patients with IBD in China.It has been joined by IBD specialists at various hospitals in China.
Detailed description
The questionnaire contained questions regarding the respondents'information, including their gender, years in practice, clinical specialty,and source of knowledge on immunization practices. The questionnaire mainly contained three sections: knowledge of vaccinations for hepatitis A virus (HAV), HBV, and varicella; current vaccination practices for the IBD group; and reasons for not recommending these vaccinations to patients with IBD. The questionnaire composed of 13 items specifically on the three vaccinations mentioned above for immunosuppressed patients with IBD. All questions were conducted based on recognized guidelines and were reviewed by 18 IBD experts. The questionnaire captured the frequency with which the respondents assessed patients with IBD for anti-HAV/hepatitis B surface antigen (HBsAg), hepatitis B core antibody, and hepatitis B surface antibody/ anti-HAV levels, and acquired infection and immunization histories. Whether the respondents recommended these three vaccines to the IBD group before treatment was also elicited.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An email with a quick response code (QRC) was sent to CCCF-affiliated gastroenterologists specializing in IBD between July 2017 and August 2017
Key inclusion criteria (1 listed)
- gastroenterologists were members of tertiary hospitals
Key exclusion criteria (1 listed)
- pediatricians were excluded, as were retired gastroenterologists and those currently in training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vaccination practices
Time frame: between July 2017 and August 2017
The questionnaire mainly contained three sections: knowledge of vaccinations for hepatitis A virus (HAV), HBV, and varicella; current vaccination practices for the IBD group; and reasons for not recommending these vaccinations to patients with IBD. The questionnaire captured the frequency with which the respondents assessed patients with IBD for anti-HAV/hepatitis B surface antigen (HBsAg), hepatitis B core antibody, and hepatitis B surface antibody/ anti-HAV levels, and acquired infection and immunization histories.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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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. This study is not recruiting at the moment.
Yan Chen study director
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaccination practices (time frame: between July 2017 and August 2017). 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 19 Jul 2021.