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

May 6, 2024 updated by: Linda Anne Feagins, MD, University of Texas at Austin

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • Dell Medical School at the University of Texas at Austin
        • Contact:
          • Linda A Feagins, MD
          • Phone Number: 512-324-7831

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Our target population will include adult subjects (ages 18 and older) with confirmed IBD who do and do not identify English as their primary language. These subjects will be either new or returning patients seen in the outpatient clinics at either the Yale New Haven Hospital system or the University of Texas at Austin affiliated hospitals or clinics. Men and women and persons of all races and ethnicities will be encouraged to participate in an equal basis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
English as primary language
Other: NO INTERVENTION
NO INTERVENTION - OBSERVATIONAL ONLY
Non-English as primary language
Other: NO INTERVENTION
NO INTERVENTION - OBSERVATIONAL ONLY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current use of advanced therapy
Time Frame: baseline
Use of or prescription of a biologic or small molecule therapy to treat inflammatory bowel disease
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
IBD-related disease complications
Time Frame: 6 months
6 months
IBD-related disease complications
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

Bristol-Myers Squibb
Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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