Crohn Disease (CD)NCT04672161
Education Intervention on Vaccination Adherence Among Inflammatory Bowel Disease (IBD) Patients
A study testing Vaccine Education in people with Crohn Disease (CD) and Ulcerative Colitis (UC), run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
A retrospective chart review and a six-month prospective outcome analysis aimed to evaluate the efficacy of a vaccination education intervention and vaccination adherence among IBD patients at Weill-Cornell Medical Center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD), Ulcerative Colitis (UC), Indeterminate Colitis
- What is being tested?
- Vaccine Education
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2021to 30 Jun 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patient at Weill-Cornell Medical Center with an in-person or virtual appointment between March 1 - August 30, 2021.
- Documentation of an IBD diagnosis (CD, UC, IC).
Who cannot join
- No documentation of an IBD diagnosis.
- Pregnant or breastfeeding.
- No scheduled appointment between March 1-August 30, 2021.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Education Intervention on Vaccination Adherence Among IBD Patients at Weill Cornell Medical Center
A retrospective chart review and a six-month prospective outcome analysis aimed to evaluate the efficacy of a vaccination education intervention and vaccination adherence among IBD patients at Weill-Cornell Medical Center. It is hypothesized that a general vaccination education campaign will improve vaccination adherence rates for all IBD patients. Secondarily, it is hypothesized that an Human Papilloma Virus (HPV) vaccination intervention targeted at high-risk IBD patients will increase vaccination adherence among these patients.
- Being tested
- Vaccine Education
- Keywords
- Vaccine, HPV, Vaccination, IBD, Inflammatory Bowel Diseases, UC, CD
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine EducationOther
A baseline educational intervention on vaccination and its role in the health maintenance of patients with IBD will be provided to all participants. Those on immunosuppressive therapies and/or those age 65 or older will also be offered the pneumonia vaccine educational intervention. Finally, patients aged 18-26 and those 27-45 who have never been vaccinated for HPV or those with high risk for HPV will additionally receive the HPV educational intervention.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Education | Experimental | Patients randomized to the Experimental arm will receive a baseline educational intervention on vaccination following a vaccination history survey. Patients will be followed 6-months after the intervention to record prospective clinical data. Evidence of vaccination-status will be documented. Besides standard of care visits and testing, no additional procedures will be carried out for the purpose of this study. Receives: Other: Vaccine Education |
| No Vaccine Education | No intervention | Patients randomized to the No Intervention arm will not receive the Vaccine Education. They will only complete the survey on their vaccination history. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Vaccination Adherence in Patients
Measured: Baseline; 6 months
Secondary outcomes (1)
Change in qualitative attitude assessment on vaccination adherence and non-adherence as measured by self-reported 6-month questionnaire.
Measured: Baseline; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start4 Feb 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana J Lukin, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672161
- Sponsor's protocol ID
- 20-06022242
- Status last verified
- Jul 2023
- First submitted
- 11 Dec 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education Intervention on Vaccination Adherence Among IBD Patients at Weill Cornell Medical Center
- ClinicalTrials.gov ID
- NCT04672161
- Acronym / sponsor ID
- 20-06022242
- Keywords
- Vaccine, HPV, Vaccination, IBD, Inflammatory Bowel Diseases, UC, CD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Dec 2020 (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.
A retrospective chart review and a six-month prospective outcome analysis aimed to evaluate the efficacy of a vaccination education intervention and vaccination adherence among IBD patients at Weill-Cornell Medical Center. It is hypothesized that a general vaccination education campaign will improve vaccination adherence rates for all IBD patients. Secondarily, it is hypothesized that an Human Papilloma Virus (HPV) vaccination intervention targeted at high-risk IBD patients will increase vaccination adherence among these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Education | Experimental | Other: Vaccine EducationPatients randomized to the Experimental arm will receive a baseline educational intervention on vaccination following a vaccination history survey. Patients will be followed 6-months after the intervention to record prospective clinical data. Evidence of vaccination-status will be documented. Besides standard of care visits and testing, no additional procedures will be carried out for the purpose of this study. |
| No Vaccine Education | No intervention | –Patients randomized to the No Intervention arm will not receive the Vaccine Education. They will only complete the survey on their vaccination history. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient at Weill-Cornell Medical Center with an in-person or virtual appointment between March 1 - August 30, 2021.
- Documentation of an IBD diagnosis (CD, UC, IC).
Key exclusion criteria (3 listed)
- No documentation of an IBD diagnosis.
- Pregnant or breastfeeding.
- No scheduled appointment between March 1-August 30, 2021.
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 |
|---|---|---|
| Vaccine EducationA baseline educational intervention on vaccination and its role in the health maintenance of patients with IBD will be provided to all participants. Those on immunosuppressive therapies and/or those age 65 or older will also be offered the pneumonia vaccine educational intervention. Finally, patients aged 18-26 and those 27-45 who have never been vaccinated for HPV or those with high risk for HPV will additionally receive the HPV educational intervention. | Other | Vaccine Education |
Primary outcome
Mean Change in Vaccination Adherence in Patients
Time frame: Baseline; 6 months
1 secondary outcome
Change in qualitative attitude assessment on vaccination adherence and non-adherence as measured by self-reported 6-month questionnaire.
Time frame: Baseline; 6 months
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 27 Jul 2023.
- 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.
Dana J Lukin, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccine Education in people with Crohn Disease (CD) and Ulcerative Colitis (UC), run by Weill Medical College of Cornell University at 1 site in United States.
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 2 inclusion and 3 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 27 Jul 2023. 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 United States. 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?
Mean Change in Vaccination Adherence in Patients (time frame: Baseline; 6 months). 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 27 Jul 2023.