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NCT04672161 Clinical Trial

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

Ulcerative Colitis (UC) Clinical Trial

Official title:
Education Intervention on Vaccination Adherence Among IBD Patients at Weill Cornell Medical Center

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04672161
Other study ID # 20-06022242
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2021
Est. completion date June 30, 2023

Study information
Verified date July 2023
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date June 30, 2023
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Weill Cornell Medicine New York New York

Sponsors (1)
Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Change in Vaccination Adherence in Patients Baseline; 6 months
Secondary Change in qualitative attitude assessment on vaccination adherence and non-adherence as measured by self-reported 6-month questionnaire. Baseline; 6 months
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