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NCT06266663 · ClinicalTrials.gov registry record
Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease
A clinical trial of Inflammatory Bowel Diseases, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- 400
- Enrollment target
- 2
- Study locations
NCT06266663: Recruiting study of Inflammatory Bowel Diseases, sponsored by Montefiore Medical Center.
NCT06266663 is a study of Inflammatory Bowel Diseases that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 400 participants, below the 42,253-participant average among 48 other Inflammatory Bowel Diseases trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06266663, a study of Inflammatory Bowel Diseases, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Survey
Study Locations (2)
New York
- Icahn School of Medicine at Mount Sinai - New York
- Montefiore Hutchinson Campus - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2024-04-26 |
| Est. Completion | 2026-06-30 |
What NCT06266663 shows while recruiting
NCT06266663 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 42,253-participant average among 48 other Inflammatory Bowel Diseases trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Inflammatory Bowel Diseases appearing as the primary indexed condition, and to 1 intervention - of which Survey is the first listed.
NCT06266663 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06266663 about?
NCT06266663 is a clinical study titled "Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease". 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 pharma...
What is the current status of trial NCT06266663?
This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2024-04-26. Estimated completion is 2026-06-30.
What conditions does trial NCT06266663 study?
This clinical trial studies the following conditions: Inflammatory Bowel Diseases.
What interventions are being tested in trial NCT06266663?
The interventions under investigation include: Survey (OTHER).
Who is sponsoring clinical trial NCT06266663?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06266663 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06266663's enrollment target sits among peer trials
400 9th of 48 higher than 39 of 48 other Inflammatory Bowel Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Bowel Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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