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OpenTrials
Completed

NCT Number: NCT04672161

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

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.

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Key information

Conditions

Crohn Disease (CD) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Indeterminate Colitis Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Mean Change in Vaccination Adherence in Patients

    Time frame: 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.

    Time frame: Baseline; 6 months

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 17, 2020
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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