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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06266663
• Other study ID #: 2022-13788
• Secondary ID: CNTO1275IBD4012
• Status: Recruiting
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Montefiore Medical Center
• Contact: Ruby Greywoode, MD
• Phone: 347-671-8205
• Email: rgreywoode[@]montefiore.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Country	Name	City	State
United States	Montefiore Hutchinson Campus	Bronx	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Montefiore Medical Center	Icahn School of Medicine at Mount Sinai, Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBD medication adherence	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	Single 20 minute survey response, upon participant enrollment
Primary	Health-related quality of life (HRQoL)	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	Single 20 minute survey response, upon participant enrollment