protocolSection identificationModule nctId: NCT06266663, orgStudyIdInfo id: 2022-13788, secondaryIdInfos id: CNTO1275IBD4012, type: OTHER, domain: Janssen Scientific Affairs, LLC, briefTitle: Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Montefiore Medical Center, class: OTHER, collaborators name: Icahn School of Medicine at Mount Sinai, collaborators name: Janssen Scientific Affairs, LLC, descriptionModule briefSummary: Optimizing health related-quality of life (HRQoL) for patients with inflammatory bowel disease (IBD), who often experience a relapsing disease course, is an essential component of care. Improving IBD disease control is linked to increased health-related quality of life. Even as many effective pharmacotherapies to promote disease control are available, evidence suggests that Hispanic and Non-Hispanic Black IBD patients may not receive full benefit from these therapies compared to their Non-Hispanic White counterparts. Underlying mechanisms that contribute to observed disparities in the use of IBD medical therapies are likely multifactorial. Adequate access to treatment has been implicated. Hispanic and Non-Hispanic Black IBD patients are more likely to be Medicaid-insured, and Medicaid insurance has been associated with increased emergency room visits, a proxy for sub-optimal IBD control. Medication adherence has also been proposed as a potential mediating factor. IBD therapies can be time-consuming and costly, which can pose a challenge in achieving medication adherence. While previous studies suggest Black IBD patients have lower medication adherence than Non-Hispanic White patients, it is unclear the extent to which social factors contribute to this observation. The purpose of this study is to evaluate the association between social determinants of health, medication adherence, and HRQoL among Hispanic and Non-Hispanic Black IBD patients. Understanding potentially modifiable psychosocial factors that contribute to medication adherence and HRQoL will provide targets for later intervention towards the goal of health equity., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: IBD medication adherence, primaryOutcomes measure: Health-related quality of life (HRQoL), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montefiore Hutchinson Campus, status: RECRUITING, city: Bronx, state: New York, zip: 10461, country: United States, contacts name: Ruby Greywoode, MD, role: CONTACT, phone: 347-671-8205, email: rgreywoode@montefiore.org, contacts name: Sheila Benitez, role: CONTACT, phone: 347-429-0253, email: sheila.benitez@einsteinmed.edu, geoPoint lat: 40.84985, lon: -73.86641, locations facility: Icahn School of Medicine at Mount Sinai, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Zoe Gottlieb, MD, role: CONTACT, email: Zoe.Gottlieb@mountsinai.org, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False