RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-26
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06266663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * age 18 years or older
  3. * ability to provide informed consent in English or Spanish
  4. * basic computer proficiency (i.e. to complete online survey)
  1. * race and ethnicity self-identified as other than Hispanic, Non-Hispanic Black, or Non-Hispanic White

Contacts and Locations

Study Contact

Ruby Greywoode, MD
CONTACT
347-671-8205
rgreywoode@montefiore.org
Sheila Benitez
CONTACT
347-429-0253
sheila.benitez@einsteinmed.edu

Principal Investigator

Ruby Greywoode, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Hutchinson Campus
Bronx, New York, 10461
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • Ruby Greywoode, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-26
Study Completion Date2024-12

Study Record Updates

Study Start Date2024-04-26
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Inflammatory Bowel Diseases