Understanding Social Factors, Medication, and Quality of Life in IBD

This study is looking at how social factors and medication use affect the quality of life for people with Inflammatory Bowel Disease (IBD). Researchers want to understand why some IBD patients, particularly Hispanic and Non-Hispanic Black individuals, might not get the full benefit from their IBD medications. The study will involve 400 IBD patients who will complete a survey. The main goals are to measure how well patients stick to their IBD medication plan and their health-related quality of life. You may be able to join if you are 18 or older, have a confirmed diagnosis of Crohn's disease, ulcerative colitis, or indeterminate colitis for at least three months, and can complete a survey in English or Spanish with basic computer skills. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information through a survey from 400 participants. It is not testing a new treatment, but rather observing current experiences.
What's involved
You would complete a single 20-minute survey upon joining the study.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06266663

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

Recruiting
Not specifiedAges 18+Observational
Montefiore Medical Center
~400 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Survey

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
IBD medication adherence
Measured over Single 20 minute survey response, upon participant enrollment
+1 more outcome measured
Inflammatory Bowel Diseases
2 sites across 1 states
New York2
  • Ruby Greywoode, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

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Eligibility criteria

Inclusion

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

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