Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-30 @ 7:06 AM
Study NCT ID:
NCT06405503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Primary Language on Treatment and Outcomes in Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2023-04-10', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Current use of advanced therapy', 'timeFrame': 'baseline', 'description': 'Use of or prescription of a biologic or small molecule therapy to treat inflammatory bowel disease'}], 'secondaryOutcomes': [{'measure': 'IBD-related disease complications', 'timeFrame': '6 months'}, {'measure': 'IBD-related disease complications', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nThis study aims to determine the impact of primary language on the selection of treatment for IBD and on disease outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years of age\n* Confirmed diagnosis of IBD (CD, UC or indeterminate colitis)\n* Willing to provide consent for participation\n* Managed at an outpatient clinic either the Yale New Haven Hospital system or the University of Texas at Austin Hospital system.\n\nExclusion Criteria:\n\n* Patients \\<18\n* No confirmed diagnosis of IBD\n* Not planning to continue care at either study site (i.e. presenting for a consultation only)\n* Unwilling to provide signed consent'}, 'identificationModule': {'nctId': 'NCT06405503', 'briefTitle': 'Impact of Primary Language on Treatment and Outcomes in Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Impact of Primary Language on Treatment and Outcomes in Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'STUDY00004331'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'English as primary language', 'interventionNames': ['Other: NO INTERVENTION']}, {'label': 'Non-English as primary language', 'interventionNames': ['Other: NO INTERVENTION']}], 'interventions': [{'name': 'NO INTERVENTION', 'type': 'OTHER', 'description': 'NO INTERVENTION - OBSERVATIONAL ONLY', 'armGroupLabels': ['English as primary language', 'Non-English as primary language']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Linda A Feagins, MD', 'role': 'CONTACT', 'phone': '512-324-7831'}], 'facility': 'Dell Medical School at the University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'centralContacts': [{'name': 'Linda A Feagins, MD', 'role': 'CONTACT', 'email': 'linda.feagins@austin.utexas.edu', 'phone': '512-324-7831'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Yale University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Linda Anne Feagins, MD', 'investigatorAffiliation': 'University of Texas at Austin'}}}}