Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-02 @ 2:06 AM
Study NCT ID:
NCT05219032
Status:
TERMINATED
Last Update Posted:
2022-02-01
First Post:
2021-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interpreters as Advocates for Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Lack of enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2021-12-31', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient reported satisfaction with the clinical encounter with their clinician', 'timeFrame': '6 months', 'description': 'Patients will rate their satisfaction with the clinical encounter with their clinician y responding to several questions about the encounter using a 5-point Likert scale.'}], 'secondaryOutcomes': [{'measure': 'Provider reported satisfaction with the clinical encounter with the patient', 'timeFrame': '6 months', 'description': 'Providers will rate their satisfaction with the clinical encounter with the patient by responding to several questions about the encounter using a 5-point Likert scale.'}, {'measure': 'Change in systolic and diastolic blood pressure', 'timeFrame': '6 months', 'description': 'Net change in systolic and diastolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Spanish'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if medical interpreters trained to advocate on behalf of their patients deliver improved care compared to standard medical interpreters', 'detailedDescription': "Over 21 million Americans have limited English proficiency. About two-thirds of these individuals speak Spanish. Limited English proficiency has major adverse impacts on health and health care. Using trained medical interpreters may help overcome this language barrier. Compared to patients who need but don't get an interpreter, patients who use trained medical interpreters have better satisfaction, quality of care, and health outcomes. However, the outcomes of patients using interpreters is often poorer than that of English-speaking patients. This randomized controlled trial will test the utility of using interpreters as advocates for Spanish-speaking inner city patients with hypertension."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spanish speaking\n* Limited English proficiency\n* Uncontrolled hypertension\n* Regular visit with primary care provider who is not proficient in Spanish\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05219032', 'briefTitle': 'Interpreters as Advocates for Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Interpreters as Advocates for Hispanic Patients With Hypertension', 'orgStudyIdInfo': {'id': 'P60MD002265DT2'}, 'secondaryIdInfos': [{'id': '5P60MD002265-03', 'link': 'https://reporter.nih.gov/quickSearch/5P60MD002265-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interpreter', 'description': 'Professional Spanish interpreter', 'interventionNames': ['Behavioral: Professional Medical Interpreter']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual care provided to patients'}], 'interventions': [{'name': 'Professional Medical Interpreter', 'type': 'BEHAVIORAL', 'description': 'A professional medical interpreter accompanies patient to each appointment.', 'armGroupLabels': ['Interpreter']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daryl Thornton', 'investigatorAffiliation': 'Case Western Reserve University'}}}}