Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-29 @ 12:17 AM
Study NCT ID:
NCT00133068
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2005-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collaboration to Reduce Disparities in Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 802}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2005-08-19', 'studyFirstSubmitQcDate': '2005-08-19', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Cost', 'timeFrame': '12 months'}, {'measure': 'Blood pressure', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['High Blood Pressure', 'Health Behaviors', 'Patient Compliance'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '26625505', 'type': 'DERIVED', 'citation': 'Volpp KG, Troxel AB, Long JA, Ibrahim SA, Appleby D, Smith JO, Jaskowiak J, Helweg-Larsen M, Doshi JA, Kimmel SE. A randomized controlled trial of co-payment elimination: the CHORD trial. Am J Manag Care. 2015 Aug;21(8):e455-64.'}]}, 'descriptionModule': {'briefSummary': 'A large number of African-American and low socioeconomic patients have poorly controlled high blood pressure because of not being able to take their high blood pressure medications. This puts these patients at higher risk of heart and kidney disease, stroke and death. This study is designed to reduce the barriers that prevent patients from taking their high blood pressure medications.', 'detailedDescription': 'The objective of this study is to determine the effectiveness and cost-effectiveness of two interventions aimed at reducing barriers to blood pressure (BP) control in an indigent and African-American population. Specifically, we will conduct a randomized controlled trial comparing BP control using either: (1) reimbursing patients for filling prescriptions (reimbursement arm); (2) a computer-based behavioral intervention (behavioral arm); (3) both the reimbursement and behavioral arms (combined arms); or (4) neither.\n\nThe ultimate goal of this study is to reduce the incidence of HTN-related CVD among these populations thereby reducing cardiovascular health disparities. Specific aims of the study are to:\n\n1. test whether receiving money each time the patient fills a prescription for medications improves BP control by a clinically significant amount.\n\n H1: Reimbursing patients for filling prescriptions will significantly improve BP control.\n2. test whether a computer-based behavioral intervention improves BP control by a clinically significant amount.\n\n H2: A computer-based behavioral intervention will significantly improve BP control.\n3. test whether the two interventions are more effective in improving BP control than either alone.\n\n H3: The effect of improving BP control of administering both interventions together will be greater than the sum of the individual effects of each intervention alone.\n4. examine the relative cost effectiveness of reimbursement for filling prescriptions, a computer-based behavioral intervention, and the combination of the two.\n\nH4: Both interventions will be cost-effective relative to other commonly-covered services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of the Philadelphia Veterans Administration Hospital Primary Care Clinic, PinnacleHealth Adult Outpatient Clinics and the VA Pittsburgh Healthcare System who have a diagnosis of hypertension; are currently taking antihypertensive medications; and have elevated blood pressure.\n\nExclusion Criteria:\n\n* Under 21 years of age\n* Have a diagnosis of:\n\n * Atrial fibrillation;\n * Metastatic cancer;\n * End stage renal disease (ESRD) with dialysis;\n * Dementia;\n * New York Heart Association (NYHA) class IV congestive heart failure (CHF);\n * Blind or deaf;\n * Other reason for life expectancy of less than 1 year.\n* Are currently participating in another experimental study'}, 'identificationModule': {'nctId': 'NCT00133068', 'briefTitle': 'Collaboration to Reduce Disparities in Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Collaboration to Reduce Disparities in Hypertension', 'orgStudyIdInfo': {'id': '707850'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Control', 'interventionNames': ['Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Reduction of financial barrier', 'interventionNames': ['Behavioral: Reduction in financial barrier']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Computer Intervention', 'interventionNames': ['Behavioral: Computer']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Reduction of financial barrier and Computer Intervention', 'interventionNames': ['Behavioral: Computer intervention & reduction of financial barrier']}], 'interventions': [{'name': 'Computer', 'type': 'BEHAVIORAL', 'description': 'Computer intervention only', 'armGroupLabels': ['3']}, {'name': 'Reduction in financial barrier', 'type': 'BEHAVIORAL', 'description': 'Copay only', 'armGroupLabels': ['2']}, {'name': 'Computer intervention & reduction of financial barrier', 'type': 'BEHAVIORAL', 'description': 'computer intervention \\& copay', 'armGroupLabels': ['4']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'No intervention', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17101', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'PinnacleHealth Adult Outpatient Clinics', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Veterans Administration Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15240', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Pittsburgh Healthcare System', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Stephen E. Kimmel, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pennsylvania Department of Health', 'class': 'OTHER_GOV'}, {'name': 'Dickinson College', 'class': 'OTHER'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Stephen E. Kimmel, M.D., M.S.C.E,', 'investigatorFullName': 'Stephen E. Kimmel', 'investigatorAffiliation': 'University of Pennsylvania'}}}}