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

NCT04672161 | Completed

• 1 other identifier: 20-06022242
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Vaccine; HPV; Vaccination; IBD; Inflammatory Bowel Diseases; UC; CD

Outcome Measures

Primary Outcomes (1)

• Mean Change in Vaccination Adherence in Patients

  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.

  Baseline; 6 months

Study Arms (2)

Vaccine Education

EXPERIMENTAL

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 Vaccine Education

NO INTERVENTION

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

Interventions

Vaccine Education OTHER

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.

Vaccine Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Dana J Lukin, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: February 4, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)