Inflammatory Bowel DiseaseNCT01984879
Vaccination Status, Knowledge and Attitude in Korean Patients With IBD
An observational study of Inflammatory Bowel Disease, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the vaccination status, knowledge about vaccination, and attitude to vaccination of the Korean patients with inflammatory bowel diseases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Survey with structured questionnaire form for inflammatory bowel disease patient group
- How many people
- 287 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inflammatory bowel diseases who are visiting Asan Medical Center and who give consent to the survey
Who may be able to join
- Crohn's disease or ulcerative colitis
- Patients who are visiting Asan Medical Center for the first time for the management of inflammatory bowel diseases
- Patients who give consent for participating in the study
Who cannot join
- Patients who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaccination Status, Knowledge About Vaccination and Attitude to Vaccination in Korean Patients With Inflammatory Bowel Diseases
The purpose of this study is to investigate the vaccination status, knowledge about vaccination, and attitude to vaccination of the Korean patients with inflammatory bowel diseases
Read the detailed description
Using structured questionnaires, the vaccination status, knowledge about vaccination, and attitude to vaccination of the Korean patients with inflammatory bowel diseases will be investigated. The descriptive analyses will be performed and the factors influencing the vaccination status, knowledge, and attitude will be investigated.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Survey with structured questionnaire form for inflammatory bowel disease patient group
- 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.
Survey with structured questionnaire form for inflammatory bowel disease patient groupOther
For patients with inflammatory bowel disease, survey with structured questionnaire form is carried out.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory bowel diseases | Patients who have inflammatory bowel diseases and who give consent to participate in the survey Receives: Other: Survey with structured questionnaire form for inflammatory bowel disease patient group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination status (MMR, DTaP, BCG, Polio, seasonal influenza, pneumococcus, HAV, HBV, HPV, VZV, and menigococcus )
Vaccination status (MMR, DTaP, BCG, Polio, seasonal influenza, pneumococcus, HAV, HBV, HPV, VZV, and menigococcus )
Measured: One year
Secondary outcomes (1)
Knowledge about vaccination in patients with inflammatory bowel diseases
Knowledge about vaccination in patients with inflammatory bowel diseases
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byong Duk Ye, Asan Medical Center
- Investigators
- Byong Duk Ye, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984879
- Sponsor's protocol ID
- 2013-0592
- Status last verified
- Dec 2022
- First submitted
- 4 Nov 2013
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yeung JH, Goodman KJ, Fedorak RN. Inadequate knowledge of immunization guidelines: a missed opportunity for preventing infection in immunocompromised IBD patients. Inflamm Bowel Dis. 2012 Jan;18(1):34-40. doi: 10.1002/ibd.21668. Epub 2011 Feb 18.
PubMed 21337671Ryu HH, Chang K, Kim N, Lee HS, Hwang SW, Park SH, Yang DH, Byeon JS, Myung SJ, Yang SK, Ye BD. Insufficient vaccination and inadequate immunization rates among Korean patients with inflammatory bowel diseases. Medicine (Baltimore). 2021 Nov 12;100(45):e27714. doi: 10.1097/MD.0000000000027714.
PubMed 34766576
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Status, Knowledge About Vaccination and Attitude to Vaccination in Korean Patients With Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT01984879
- Acronym / sponsor ID
- 2013-0592
- Conditions
- Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Nov 2013 (estimated)
- 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 purpose of this study is to investigate the vaccination status, knowledge about vaccination, and attitude to vaccination of the Korean patients with inflammatory bowel diseases
Detailed description
Using structured questionnaires, the vaccination status, knowledge about vaccination, and attitude to vaccination of the Korean patients with inflammatory bowel diseases will be investigated. The descriptive analyses will be performed and the factors influencing the vaccination status, knowledge, and attitude will be investigated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel diseases | – | Other: Survey with structured questionnaire form for inflammatory bowel disease patient groupPatients who have inflammatory bowel diseases and who give consent to participate in the survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory bowel diseases who are visiting Asan Medical Center and who give consent to the survey
Key inclusion criteria (3 listed)
- Crohn's disease or ulcerative colitis
- Patients who are visiting Asan Medical Center for the first time for the management of inflammatory bowel diseases
- Patients who give consent for participating in the study
Key exclusion criteria (1 listed)
- Patients who refuse to participate in the study
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 |
|---|---|---|
| Survey with structured questionnaire form for inflammatory bowel disease patient groupFor patients with inflammatory bowel disease, survey with structured questionnaire form is carried out. | Other | Inflammatory bowel diseases |
Primary outcome
Vaccination status (MMR, DTaP, BCG, Polio, seasonal influenza, pneumococcus, HAV, HBV, HPV, VZV, and menigococcus )
Time frame: One year
Vaccination status (MMR, DTaP, BCG, Polio, seasonal influenza, pneumococcus, HAV, HBV, HPV, VZV, and menigococcus )
1 secondary outcome
Knowledge about vaccination in patients with inflammatory bowel diseases
Time frame: One year
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 28 Dec 2022.
- Background: PubMed 21337671Yeung JH, Goodman KJ, Fedorak RN. Inadequate knowledge of immunization guidelines: a missed opportunity for preventing infection in immunocompromised IBD patients. Inflamm Bowel Dis. 2012 Jan;18(1):34-40. doi: 10.1002/ibd.21668. Epub 2011 Feb 18.
- Derived from this study: PubMed 34766576Ryu HH, Chang K, Kim N, Lee HS, Hwang SW, Park SH, Yang DH, Byeon JS, Myung SJ, Yang SK, Ye BD. Insufficient vaccination and inadequate immunization rates among Korean patients with inflammatory bowel diseases. Medicine (Baltimore). 2021 Nov 12;100(45):e27714. doi: 10.1097/MD.0000000000027714.
- Individual participant dataSharing planned: No
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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.
Byong Duk Ye, MD, PhD principal investigator
Asan Medical Center
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 Disease, run by Asan Medical Center at 1 site in South Korea.
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 3 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 28 Dec 2022. 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 South Korea. 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 status (MMR, DTaP, BCG, Polio, seasonal influenza, pneumococcus, HAV, HBV, HPV, VZV, and menigococcus ) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01984879, which also lists 2 linked publications.
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 28 Dec 2022.