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Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease

Montefiore Medicine Academic Health System logo

Montefiore Medicine Academic Health System

Status

Enrolling

Conditions

Inflammatory Bowel Diseases

Treatments

Other: Survey

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06266663
2022-13788
CNTO1275IBD4012 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • clinical diagnosis of Crohn's disease, ulcerative colitis, or indeterminate colitis ≥ 3 months investigator confirmed on the basis of supportive clinical data such as colonoscopy, pathology and/or radiology
  • age 18 years or older
  • ability to provide informed consent in English or Spanish
  • basic computer proficiency (i.e. to complete online survey)

Exclusion criteria

  • race and ethnicity self-identified as other than Hispanic, Non-Hispanic Black, or Non-Hispanic White

Trial contacts and locations

2

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Central trial contact

Ruby Greywoode, MD; Shalika Fnu

Data sourced from clinicaltrials.gov

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