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

Not Applicable

Completed

• Conditions: Ulcerative Colitis (UC); Indeterminate Colitis; Crohn Disease (CD)
• Interventions: Other: Vaccine Education

• Registration Number: NCT04672161
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-17
• Study Start: 2021-02-04
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaccine Education	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.

Primary Outcome Measures

Name	Time	Method
Mean Change in Vaccination Adherence in Patients	Baseline; 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States