Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06266663

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

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2024-04-26

Completion Date

2026-06-30

Last Updated

2026-02-02

Healthy Volunteers

Yes

Interventions

OTHER

Survey

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.

Locations (2)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Montefiore Hutchinson Campus

The Bronx, New York, United States