Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT01013857
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2009-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating to Target for 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2009-11-13', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Diastolic blood pressure', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '20003300', 'type': 'DERIVED', 'citation': 'Bennett H, Laird K, Margolius D, Ngo V, Thom DH, Bodenheimer T. The effectiveness of health coaching, home blood pressure monitoring, and home-titration in controlling hypertension among low-income patients: protocol for a randomized controlled trial. BMC Public Health. 2009 Dec 10;9:456. doi: 10.1186/1471-2458-9-456.'}]}, 'descriptionModule': {'briefSummary': 'Patients with poorly controlled hypertension will have improved hypertensive control with telephone coaching and with telephone coaching combined with home-titration of medications.', 'detailedDescription': "Patients with poorly controlled hypertension are randomized to a control arm which receives telephone coaching or an active arm which receives telephone coaching plus intensification of medications via telephone coaching with the coaches using treatment algorithms approved by the patients' physician. These patients' blood pressure control will be compared with usual care patients in a passive arm (chart review only)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2 blood pressure readings above 145/90.\n\nExclusion Criteria:\n\n* Cognitive impairment,\n* Short life expectancy,\n* Creatinine greater than 1.5,\n* Inability to check blood pressures at home.'}, 'identificationModule': {'nctId': 'NCT01013857', 'briefTitle': 'Treating to Target for Patients With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Treating to Target for Patients With Hypertension', 'orgStudyIdInfo': {'id': 'H40013-33128-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Health coaching', 'description': 'Phone patients every week to discuss medication adherence', 'interventionNames': ['Behavioral: Health coaching']}, {'type': 'EXPERIMENTAL', 'label': 'Health coaching plus home-titration', 'description': 'Health coaches call patients every week to discuss medication adherence and to intensify medications if appropriate according to physician-created algorithm', 'interventionNames': ['Behavioral: Health coaching plus home titration']}], 'interventions': [{'name': 'Health coaching', 'type': 'BEHAVIORAL', 'description': 'Calling patients every week to discuss medication adherence', 'armGroupLabels': ['Health coaching']}, {'name': 'Health coaching plus home titration', 'type': 'BEHAVIORAL', 'description': 'Calling patients every week and intensifying medications if appropriate based on physician-created algorithm', 'armGroupLabels': ['Health coaching plus home-titration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Thomas Bodenheimer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}