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

Recruiting

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT06266663
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Study Start: 2024-04-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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)

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Exclusion Criteria

• race and ethnicity self-identified as other than Hispanic, Non-Hispanic Black, or Non-Hispanic White

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IBD medication adherence	Single 20 minute survey response, upon participant enrollment	The outcome of IBD medication adherence will be categorized by the adapted Hill Bone Medication Adherence Scale (HB-MAS). This part of the questionnaire consists of eight items used to assess patients' self-reported IBD oral medication adherence. Participant responses are scored on a scale from 1-4 (1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = None of the time). Lower overall scores are associated with better medication adherence
Health-related quality of life (HRQoL)	Single 20 minute survey response, upon participant enrollment	HRQoL will be categorized based on responses to the NIH Patient Reported Outcomes Measurement Information System-29 (PROMIS-29). PROMIS-29 assesses each of 7 domains (Depression, Anxiety, Physical function, Pain interference, Fatigue, Sleep disturbance, Ability to participate in social roles and activities) using 4 questions with an additional Pain Intensity question. Participants' responses are scored from 1-5 (with the exception of the Pain Intensity Question which is scored from 0-10). The sum of each of the 7 PROMIS domains results in a raw score (from 4-20). There is no total score. Each axis forms its own score. PROMIS assessments use an Item Response Theory (IRT) based score called "Expected A Posteriori" or EAP scores, which are then transformed to a final T-score metric. As such, scores are mapped so that the values follow a normal distribution with a population mean T-score of 50 and a standard deviation of 10

Trial Locations

Locations (2)

Montefiore Hutchinson Campus; 🇺🇸 Bronx, New York, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States