Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-03-09 @ 4:51 PM
Study NCT ID:
NCT00233220
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2005-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Control in African Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1039}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-12', 'studyFirstSubmitDate': '2005-10-03', 'studyFirstSubmitQcDate': '2005-10-03', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Control BP', 'timeFrame': 'Measured at Year 1'}], 'secondaryOutcomes': [{'measure': 'Change in systolic BP and diastolic BP', 'timeFrame': 'Measured at Year 1'}, {'measure': 'Maintenance of the intervention effects', 'timeFrame': 'Measured at Year 1'}, {'measure': 'Cost effectiveness of the intervention', 'timeFrame': 'Measured at Year 1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '20031845', 'type': 'BACKGROUND', 'citation': 'Ogedegbe G, Tobin JN, Fernandez S, Gerin W, Diaz-Gloster M, Cassells A, Khalida C, Pickering T, Schoenthaler A, Ravenell J. Counseling African Americans to Control Hypertension (CAATCH) trial: a multi-level intervention to improve blood pressure control in hypertensive blacks. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):249-56. doi: 10.1161/CIRCOUTCOMES.109.849976.'}, {'pmid': '21884616', 'type': 'BACKGROUND', 'citation': 'Fernandez S, Tobin JN, Cassells A, Diaz-Gloster M, Kalida C, Ogedegbe G. The counseling African Americans to Control Hypertension (CAATCH) Trial: baseline demographic, clinical, psychosocial, and behavioral characteristics. Implement Sci. 2011 Sep 1;6:100. doi: 10.1186/1748-5908-6-100.'}, {'pmid': '24677163', 'type': 'DERIVED', 'citation': 'Forsyth J, Schoenthaler A, Chaplin WF, Ogedegbe G, Ravenell J. Perceived discrimination and medication adherence in black hypertensive patients: the role of stress and depression. Psychosom Med. 2014 Apr;76(3):229-36. doi: 10.1097/PSY.0000000000000043.'}, {'pmid': '24657991', 'type': 'DERIVED', 'citation': 'Ogedegbe G, Tobin JN, Fernandez S, Cassells A, Diaz-Gloster M, Khalida C, Pickering T, Schwartz JE. Counseling African Americans to Control Hypertension: cluster-randomized clinical trial main effects. Circulation. 2014 May 20;129(20):2044-51. doi: 10.1161/CIRCULATIONAHA.113.006650. Epub 2014 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effectiveness of a multi-component evidence-based intervention that targets both patients and physicians, in improving BP control rates in patients followed in 30 Community/Migrant Health Centers (C/MHCs).', 'detailedDescription': 'BACKGROUND:\n\nAfrican Americans (AA) have the highest prevalence of hypertension (HTN) in the U.S., with a resultant greater HTN-related mortality compared to whites. Barriers to BP Control in AA exist at 3 levels of care: the patient, the physician, and the healthcare system. Using the Chronic Care Model as a framework, the investigators seek to test the effect on BP control of a multicomponent, multi-level intervention targeted at physicians and patients.\n\nDESIGN NARRATIVE:\n\nUsing the Chronic Care Model as a framework, the investigators seek to test the effect on BP control of a multicomponent, multi-level intervention targeted at physicians and patients. They will conduct a clustered randomized controlled trial in which 30 C/MHCs will be randomized to either the intervention or usual care. A total of 990 patients with uncontrolled HTN (BP greater than 140/90 mm Hg) will be enrolled for this trial. Components of the patient intervention include an innovative patient education approach known as Self-Paced Programmed Instruction that will be used to educate patients on knowledge of HTN; behavioral counseling by trained C/MHC dieticians on lifestyle modification; and home BP monitoring to activate patients in their own care. The physician intervention comprises online continuing medical education (CME) courses on management of HTN based on the Joint National Committee-7 (JNC-7) guidelines; online HTN rounds or case conferences with HTN specialists; and feedback to physicians on clinical performance measures via computerized decision support systems. The intervention will be delivered to patients every 3 months during regular office visits for 12 months, while the physician intervention will occur every month for the duration of the trial. Patients and physicians at the usual care C/MHCs will receive NHLBI patient education materials and print versions of JNC-7 guidelines respectively.\n\nThe primary outcome is the proportion of patients with adequate BP control at 12 months in each condition as defined by JNC-7 criteria (BP less than 130/80 mm Hg for patients with diabetes or kidney disease; and BP less than 140/90 mm Hg for all other patients). The secondary outcomes are within-patient change in systolic BP and diastolic BP from baseline to 12 months; the maintenance of the intervention effects one year after trial; and the cost effectiveness of the intervention at 12 months. The long-term goal of this project is to refine the intervention as a result of the data obtained and to develop a standardized protocol that can be integrated into the usual care procedures of the C/MHCs. Thus, maximizing the likelihood that the intervention will be translated into practice, at each of the participating Community Health Centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncontrolled Hypertension\n* African American'}, 'identificationModule': {'nctId': 'NCT00233220', 'briefTitle': 'Blood Pressure Control in African Americans', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Multi-site Randomized Controlled Trial for Blood Pressure Control in Hypertensive African Americans', 'orgStudyIdInfo': {'id': '322'}, 'secondaryIdInfos': [{'id': 'R01HL078566', 'link': 'https://reporter.nih.gov/quickSearch/R01HL078566', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients and doctors will take part in a multicomponent, multi-level intervention.', 'interventionNames': ['Behavioral: Multicomponent, multi-level intervention targeted at physicians and patients']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Patients will receive usual care.', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Multicomponent, multi-level intervention targeted at physicians and patients', 'type': 'BEHAVIORAL', 'description': 'The patient intervention will include an innovative patient education approach known as Self-Paced Programmed Instruction that will be used to educate patients on knowledge of HTN; behavioral counseling by trained C/MHC dieticians on lifestyle modification; and home BP monitoring to activate patients in their own care. The physician intervention comprises online continuing medical education (CME) courses on management of HTN based on the Joint National Committee-7 (JNC-7) guidelines; online HTN rounds or case conferences with HTN specialists; and feedback to physicians on clinical performance measures via computerized decision support systems. The intervention will be delivered to patients every 3 months during regular office visits for 12 months, while the physician intervention will occur every month for the duration of the trial.', 'armGroupLabels': ['1']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Patients will receive usual care.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Gbenga G Ogedegbe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gbenga Ogedegbe', 'investigatorAffiliation': 'NYU Langone Health'}}}}