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CompletedNCT04672161Updated Jul 27, 2023

Education Intervention on Vaccination Adherence Among Inflammatory Bowel Disease (IBD) Patients

An interventional study of Vaccine Education in Crohn Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Crohn Disease (CD)
  • Ulcerative Colitis (UC)
  • Indeterminate Colitis

Keywords

  • Vaccine
  • HPV
  • Vaccination
  • IBD
  • Inflammatory Bowel Diseases
  • UC
  • CD
03

In context

Crohn Disease

1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.

This study's enrollment of 200 is above the median of 66 across 1,212 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 164 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • No documentation of an IBD diagnosis.
  • Pregnant or breastfeeding.
  • No scheduled appointment between March 1-August 30, 2021.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Vaccine Education

    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.

    Other: Vaccine Education

  • No intervention
    No Vaccine Education

    Patients randomized to the No Intervention arm will not receive the Vaccine Education. They will only complete the survey on their vaccination history.

Interventions

  • OtherVaccine Education

    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.

06

What researchers measure

Primary outcomes

  1. Mean Change in Vaccination Adherence in Patients

    Time frame: 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.

    Time frame: Baseline; 6 months

07

Study locations

1 site
  • Weill Cornell Medicine
    New York, New York 10065, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04672161
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
Feb 4, 2021
Primary completion
Jun 30, 2022
Completion
Jun 30, 2023
Last update
Jul 27, 2023

Study contacts

Dana J Lukin, MD, PhD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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