Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT01037920
Status:
COMPLETED
Last Update Posted:
2012-07-13
First Post:
2009-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-11', 'studyFirstSubmitDate': '2009-12-18', 'studyFirstSubmitQcDate': '2009-12-18', 'lastUpdatePostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'medication adherence', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '3-6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '23128568', 'type': 'DERIVED', 'citation': 'Havranek EP, Hanratty R, Tate C, Dickinson LM, Steiner JF, Cohen G, Blair IA. The effect of values affirmation on race-discordant patient-provider communication. Arch Intern Med. 2012 Nov 26;172(21):1662-7. doi: 10.1001/2013.jamainternmed.258.'}]}, 'descriptionModule': {'briefSummary': "The objective of the project is a test-of-concept of an intervention to reduce the effects of the perception of discrimination on the care of patients with chronic illness. Perception of discrimination manifests itself as stereotype threat. We hypothesize that stereotype threat impairs communication between minority patients and their physicians because of increased stress and diminished trust, resulting in interactions that are less successful at enhancing patient self-efficacy, in turn resulting in lower rates of adherence with anti-hypertensive medication.\n\nThe intervention is a self-affirmation exercise performed prior to a patient-physician visit. A similar intervention has been shown to reduce the racial gap in academic performance in middle school classrooms.\n\nWe will explore the mechanistic effects of the intervention by analysis of audiotapes of patient-provider visits following the intervention. We will measure the effect of the intervention on minority hypertensive patients' adherence with antihypertensive medication and blood pressure.\n\nWe will enroll 200 African American and Latino patients with hypertension and randomize 100 patients to perform the exercise and 100 patients to perform a null control exercise before the visit. We will assess change in patient's adherence with antihypertensive medications and in blood pressure over the six months following the index visit. In order to better understand the effects of the intervention we will measure subject's mood following the exercise, and self-reported stress levels, trust in the physician, and medication self-efficacy following the visit. We will also assess the quality of the patient-provider interaction from detailed analysis of audiotapes and from patient questionnaires. Following a subsequent patient-physician visit, we will conduct telephone interviews with patients to assess for persistence of any effects of the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of hypertension\n* age \\> 21 years\n* use of Denver Health as their usual source of care and pharmacy services\n* self-described race/ethnicity of African American or Latino\n* ability to provide informed consent\n\nExclusion Criteria:\n\n* pregnancy-related hypertension\n* end-stage renal disease\n* unable to speak or write English at at least a 6th grade level.'}, 'identificationModule': {'nctId': 'NCT01037920', 'briefTitle': 'An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Denver Health and Hospital Authority'}, 'officialTitle': 'An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension', 'orgStudyIdInfo': {'id': 'R21HL089623', 'link': 'https://reporter.nih.gov/quickSearch/R21HL089623', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'subjects in the intervention arm will complete a self-affirmation exercise prior to a physician visit', 'interventionNames': ['Behavioral: Self-affirmation exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'subjects in the intervention arm will complete a sham exercise prior to a physician visit', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Self-affirmation exercise', 'type': 'BEHAVIORAL', 'description': 'The intervention exercise asks subjects to reflect on a list of 11 personal values and to circle 2 or 3 items that are most important to them. Subjects are asked then to write a few sentences to describe why they are important.', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'The control exercise is the same as the intervention exercise except that subjects reflect and write about values important to someone else.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denver Health and Hospital Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}