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NCT06405503 Clinical Trial

Impact of Primary Language on Treatment and Outcomes in Inflammatory Bowel Disease

Inflammatory Bowel Disease Clinical Trial

Official title:
Impact of Primary Language on Treatment and Outcomes in Inflammatory Bowel Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06405503
Other study ID # STUDY00004331
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date June 30, 2025

Study information
Verified date May 2024
Source University of Texas at Austin
Contact Linda A Feagins, MD
Phone 512-324-7831
Email linda.feagins@austin.utexas.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A thorough discussion of treatment options to manage inflammatory bowel disease (IBD), including the risks and benefits of each class of medication, can be a complex discussion and time consuming. Having to use a translator adds an additional layer of time and complexity to these discussions as well as potential misunderstanding. Further, in addition to language, cultural differences can also play into treatment acceptance. This study aims to determine the impact of primary language on the selection of treatment for IBD and on disease outcomes.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 206
Est. completion date June 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 years of age - Confirmed diagnosis of IBD (CD, UC or indeterminate colitis) - Willing to provide consent for participation - Managed at an outpatient clinic either the Yale New Haven Hospital system or the University of Texas at Austin Hospital system. Exclusion Criteria: - Patients <18 - No confirmed diagnosis of IBD - Not planning to continue care at either study site (i.e. presenting for a consultation only) - Unwilling to provide signed consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• NO INTERVENTION
NO INTERVENTION - OBSERVATIONAL ONLY

Locations
Country Name City State
United States Dell Medical School at the University of Texas at Austin Austin Texas

Sponsors (3)
Lead Sponsor Collaborator
University of Texas at Austin Bristol-Myers Squibb, Yale University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Current use of advanced therapy Use of or prescription of a biologic or small molecule therapy to treat inflammatory bowel disease baseline
Secondary IBD-related disease complications 6 months
Secondary IBD-related disease complications 12 months
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