Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease
Observational · No treatment assigned · 2 sites · Montefiore Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 400 participants are expected to take part.
- Start date: 2024-04-26.
- Main results expected around 2026-09-30 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in United States.
Main thing being measured
- IBD medication adherence (Single 20 minute survey response, upon participant enrollment)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | Montefiore Medical Center |
| Collaborators | Icahn School of Medicine at Mount Sinai; Janssen Scientific Affairs, LLC |
| Enrollment | 400 (estimated) |
| Start date | 2024-04-26 |
| Primary completion (est.) | 2026-09-30 |
| First posted | 2024-02-20 |
| Last updated | 2026-08-05 |
| Official title | Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT06266663 |
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.
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York, New York | United States | Recruiting |
| Montefiore Hutchinson Campus | The Bronx, New York | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.