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

Montefiore Medical Center · with Icahn School of Medicine at Mount Sinai, Janssen Scientific Affairs, LLC · NCT06266663

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
400
US sites recruiting
2
Study start
April 26, 2024
Record last updated
August 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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.

Being studied: Survey

Conditions: Inflammatory Bowel Diseases

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Icahn School of Medicine at Mount Sinai

    New York, NY 10029

    Site contact: Zoe Gottlieb, MD · Zoe.Gottlieb@mountsinai.org

  • Montefiore Hutchinson Campus

    The Bronx, NY 10461

    Site contact: Ruby Greywoode, MD · 347-671-8205 · rgreywoode@montefiore.org

Study contacts (from the official record)

  • Ruby Greywoode, MD · 347-671-8205 · rgreywoode@montefiore.org
  • Shalika Fnu · 347-968-4203 · fnu.shalika@einsteinmed.edu
Social Determinants of Health, Medication Use, and Quality of Life… (NCT06266663) | Bored Studies