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

July 24, 2023 updated by: Weill Medical College of Cornell University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change in Vaccination Adherence in Patients
Time Frame: Baseline; 6 months
Baseline; 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in qualitative attitude assessment on vaccination adherence and non-adherence as measured by self-reported 6-month questionnaire.
Time Frame: Baseline; 6 months
Baseline; 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Dana J Lukin, MD, PhD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-06022242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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