Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-29 @ 9:49 AM
Study NCT ID:
NCT04672161
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2020-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Education Intervention on Vaccination Adherence Among Inflammatory Bowel Disease (IBD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Vaccination Adherence in Patients', 'timeFrame': 'Baseline; 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in qualitative attitude assessment on vaccination adherence and non-adherence as measured by self-reported 6-month questionnaire.', 'timeFrame': 'Baseline; 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccine', 'HPV', 'Vaccination', 'IBD', 'Inflammatory Bowel Diseases', 'UC', 'CD'], 'conditions': ['Crohn Disease (CD)', 'Ulcerative Colitis (UC)', 'Indeterminate Colitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient at Weill-Cornell Medical Center with an in-person or virtual appointment between March 1 - August 30, 2021.\n* Documentation of an IBD diagnosis (CD, UC, IC).\n\nExclusion Criteria:\n\n* No documentation of an IBD diagnosis.\n* Pregnant or breastfeeding.\n* No scheduled appointment between March 1-August 30, 2021.'}, 'identificationModule': {'nctId': 'NCT04672161', 'briefTitle': 'Education Intervention on Vaccination Adherence Among Inflammatory Bowel Disease (IBD) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Education Intervention on Vaccination Adherence Among IBD Patients at Weill Cornell Medical Center', 'orgStudyIdInfo': {'id': '20-06022242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccine Education', '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.', 'interventionNames': ['Other: Vaccine Education']}, {'type': 'NO_INTERVENTION', 'label': 'No Vaccine Education', 'description': 'Patients randomized to the No Intervention arm will not receive the Vaccine Education. They will only complete the survey on their vaccination history.'}], 'interventions': [{'name': 'Vaccine Education', 'type': 'OTHER', '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.', 'armGroupLabels': ['Vaccine Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Dana J Lukin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}