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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Ulcerative Colitis (UC); Indeterminate Colitis; Crohn Disease (CD)

Treatments: Other: Vaccine Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04672161

20-06022242

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Vaccine Education

Experimental group

Description:

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.

Treatment:

Other: Vaccine Education

No Vaccine Education

No Intervention group

Description:

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