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

NCT06266663 | Recruiting

• 2 other identifiers: 2022-13788CNTO1275IBD4012
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Survey OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: collaborator
• Montefiore Medical Center: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Montefiore Hutchinson Campus

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (7)

• Szigethy EM, Allen JI, Reiss M, Cohen W, Perera LP, Brillstein L, Cross RK, Schwartz DA, Kosinski LR, Colton JB, LaRusso E, Atreja A, Regueiro MD. White Paper AGA: The Impact of Mental and Psychosocial Factors on the Care of Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2017 Jul;15(7):986-997. doi: 10.1016/j.cgh.2017.02.037. Epub 2017 Mar 12.

  PMID: 28300693 BACKGROUND

• Kappelman MD, Long MD, Martin C, DeWalt DA, Kinneer PM, Chen W, Lewis JD, Sandler RS. Evaluation of the patient-reported outcomes measurement information system in a large cohort of patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1315-23.e2. doi: 10.1016/j.cgh.2013.10.019. Epub 2013 Oct 29.

  PMID: 24183956 BACKGROUND

• Nguyen GC, LaVeist TA, Harris ML, Wang MH, Datta LW, Brant SR. Racial disparities in utilization of specialist care and medications in inflammatory bowel disease. Am J Gastroenterol. 2010 Oct;105(10):2202-8. doi: 10.1038/ajg.2010.202. Epub 2010 May 18.

  PMID: 20485281 BACKGROUND

• Damas OM, Jahann DA, Reznik R, McCauley JL, Tamariz L, Deshpande AR, Abreu MT, Sussman DA. Phenotypic manifestations of inflammatory bowel disease differ between Hispanics and non-Hispanic whites: results of a large cohort study. Am J Gastroenterol. 2013 Feb;108(2):231-9. doi: 10.1038/ajg.2012.393. Epub 2012 Dec 18.

  PMID: 23247580 BACKGROUND

• Barnes EL, Loftus EV Jr, Kappelman MD. Effects of Race and Ethnicity on Diagnosis and Management of Inflammatory Bowel Diseases. Gastroenterology. 2021 Feb;160(3):677-689. doi: 10.1053/j.gastro.2020.08.064. Epub 2020 Oct 21.

  PMID: 33098884 BACKGROUND

• Nguyen GC, Sam J, Murthy SK, Kaplan GG, Tinmouth JM, LaVeist TA. Hospitalizations for inflammatory bowel disease: profile of the uninsured in the United States. Inflamm Bowel Dis. 2009 May;15(5):726-33. doi: 10.1002/ibd.20825.

  PMID: 19067416 BACKGROUND

• Nguyen GC, LaVeist TA, Harris ML, Datta LW, Bayless TM, Brant SR. Patient trust-in-physician and race are predictors of adherence to medical management in inflammatory bowel disease. Inflamm Bowel Dis. 2009 Aug;15(8):1233-9. doi: 10.1002/ibd.20883.

  PMID: 19177509 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ruby Greywoode, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruby Greywoode, MD

CONTACT

347-671-8205; rgreywoode@montefiore.org

Shalika Fnu

CONTACT

347-968-4203; fnu.shalika@einsteinmed.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: April 26, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)