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NCT06266663Completed

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

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Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
366 (actual)
First submitted
12 Feb 2024
Start date
26 Apr 2024
Primary completion date
26 Aug 2026
Lead sponsor
Montefiore Medical Center
NCT number
NCT06266663

What you commit to

  • Study type: Observational
  • Participants enrolled: 366
  • From 26 Apr 2024 to the primary completion date, 26 Aug 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • clinical diagnosis of Crohn's disease, ulcerative colitis, or indeterminate colitis for at least 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)

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Icahn School of Medicine at Mount SinaiNew YorkUnited StatesUnknown status
Montefiore Hutchinson CampusThe BronxUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.