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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vaccine Education
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crohn Disease (CD) focused on measuring Vaccine, HPV, Vaccination, IBD, Inflammatory Bowel Diseases, UC, CD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vaccine Education

No Vaccine Education

Arm 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.

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

Outcomes

Primary Outcome Measures

Mean Change in Vaccination Adherence in Patients

Secondary Outcome Measures

Change in qualitative attitude assessment on vaccination adherence and non-adherence as measured by self-reported 6-month questionnaire.

Full Information

First Posted
December 11, 2020
Last Updated
July 24, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04672161
Brief Title
Education Intervention on Vaccination Adherence Among Inflammatory Bowel Disease (IBD) Patients
Official Title
Education Intervention on Vaccination Adherence Among IBD Patients at Weill Cornell Medical Center
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease (CD), Ulcerative Colitis (UC), Indeterminate Colitis
Keywords
Vaccine, HPV, Vaccination, IBD, Inflammatory Bowel Diseases, UC, CD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine Education
Arm Type
Experimental
Arm 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.
Arm Title
No Vaccine Education
Arm Type
No Intervention
Arm Description
Patients randomized to the No Intervention arm will not receive the Vaccine Education. They will only complete the survey on their vaccination history.
Intervention Type
Other
Intervention Name(s)
Vaccine Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change in Vaccination Adherence in Patients
Time Frame
Baseline; 6 months
Secondary Outcome Measure Information:
Title
Change in qualitative attitude assessment on vaccination adherence and non-adherence as measured by self-reported 6-month questionnaire.
Time Frame
Baseline; 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana J Lukin, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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