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
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
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