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Inflammatory Bowel DiseasesNCT06266663

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

An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Montefiore Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Survey
How many people
366 participants
Where
2 sitesUnited States
Study dates
26 Apr 2024to 26 Aug 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • clinical diagnosis of Crohn's disease, ulcerative colitis, or indeterminate colitis for at least 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Montefiore Hutchinson Campus

    The Bronx, New York, 10461

Other trials in United States

About this study

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.

Being tested
Survey
Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurveyOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Single 20 minute survey response, upon participant enrollment

  2. 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" (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

    Measured: Single 20 minute survey response, upon participant enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start26 Apr 2024
  3. Primary completion26 Aug 2026
  4. Study completion26 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06266663
Sponsor's protocol ID
2022-13788
Other IDs
CNTO1275IBD4012
Status last verified
Nov 2026
First submitted
12 Feb 2024
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28300693

  • 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.

    PubMed 24183956

  • 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.

    PubMed 20485281

  • 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.

    PubMed 23247580

  • 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.

    PubMed 33098884

  • 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.

    PubMed 19067416

  • 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.

    PubMed 19177509

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Montefiore Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IBD medication adherence (time frame: Single 20 minute survey response, upon participant enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06266663, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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