Recruiting

Inflammatory Bowel Disease

Sponsor:

Montefiore Medical Center

Code:

NCT06266663

Conditions

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Survey

Study Details

Brief 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.

Conditions

Inflammatory Bowel Diseases

Study ID

NCT06266663

Start date

Apr 26, 2024

Status verified date

Aug, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • IBD medication adherence [ Time Frame: Single 20 minute survey response, upon participant enrollment ]
  • Health-related quality of life (HRQoL) [ Time Frame: Single 20 minute survey response, upon participant enrollment ]

Central Contacts and Locations

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Montefiore Hutchinson Campus

Recruiting

The Bronx, New York, United States, 10461

Contacts

More Information

Sponsor

Montefiore Medical Center

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-08-05.