Clinical trial NCT06266663: Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease
Official title: Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Janssen Scientific Affairs, LLC
First posted: 2024-02-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients age 18 years or older with IBD who meet the above inclusion/exclusion criteria will be eligible to participate in the study. Participants will be grouped by race and ethnicity (Hispanic, Non-Hispanic Black, or Non-Hispanic White). Participants who identify as Hispanic will be further grouped by preferred language (English or Spanish). Participants will also be grouped into either public (e.g. Medicaid, Medicare) or private insurance. The study team plans to recruit 25 participants per cell: race and ethnicity (4), study site (2), insurance (2). Target recruitment is 200 participants per site for a total of 400 participants.

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.


Eligibility 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

Primary outcomes:
measure: IBD medication adherence
timeFrame: Single 20 minute survey response, upon participant enrollment
measure: Health-related quality of life (HRQoL)
timeFrame: Single 20 minute survey response, upon participant enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Hutchinson Campus
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Ruby Greywoode, MD
role: PRINCIPAL_INVESTIGATOR
References: