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

Part of paid clinical trials in New York, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT06266663
Status
Recruiting
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Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Survey — OTHER
    A cross-sectional survey of 400 IBD patients who will be actively recruited from the gastroenterology (GI) specialty clinics at Einstein-Montefiore Medical Center and Icahn School of Medicine at Mount Sinai Hospital. The survey will consist of validated screening measures on social domains known to affect health outcomes as well as measures of medication adherence and HRQoL.

Study Details

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.

Key Dates

Start date
Apr 26, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
400 participants (estimated)

Primary Outcome Measure

IBD medication adherence [ Time Frame: Single 20 minute survey response, upon participant enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Zoe Gottlieb, MD
[email protected]
Montefiore Hutchinson CampusThe BronxNew York10461
Ruby Greywoode, MD
[email protected]
347-671-8205
Shalika Fnu
[email protected]
347-968-4203

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By research site
Icahn School of Medicine at Mount Sinai· New York, NYMontefiore Hutchinson Campus· The Bronx, NY

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