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

NCT06405503 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00004331
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Current use of advanced therapy

  Use of or prescription of a biologic or small molecule therapy to treat inflammatory bowel disease

  baseline

Secondary Outcomes (2)

• IBD-related disease complications

  6 months

• IBD-related disease complications

  12 months

Study Arms (2)

English as primary language

Other: NO INTERVENTION

Non-English as primary language

Other: NO INTERVENTION

Interventions

NO INTERVENTION OTHER

NO INTERVENTION - OBSERVATIONAL ONLY

English as primary language; Non-English as primary language

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Bristol-Myers Squibb: collaborator
• Yale University: collaborator

Study Sites (1)

Dell Medical School at the University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Linda A Feagins, MD

CONTACT

512-324-7831; linda.feagins@austin.utexas.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 8, 2024
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)