Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-04-02 @ 2:30 AM
Study NCT ID:
NCT01910857
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2013-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Hypertension Control
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2013-07-23', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure (mmHg)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '26118144', 'type': 'DERIVED', 'citation': 'Tully M, Kos A, Eastwood D, Kusch J, Kotchen T. Implementation of an Adjunct Strategy to Reduce Blood Pressure in Blacks with Uncontrolled Hypertension: a Pilot Project. Ethn Dis. 2015 Spring;25(2):168-74.'}]}, 'descriptionModule': {'briefSummary': '* The overall hypothesis for the project is that racial health disparities will be reduced by improving hypertension control in African Americans.\n* This will be accomplished through the development, implementation, and evaluation of a cost-effective hypertension control strategy based on the involvement of a community health worker.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African Americans with uncontrolled hypertension, followed at Progressive Community Health Centers'}, 'identificationModule': {'nctId': 'NCT01910857', 'briefTitle': 'Improving Hypertension Control', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'orgStudyIdInfo': {'id': 'PRO16801'}, 'secondaryIdInfos': [{'id': 'HWPP', 'type': 'OTHER_GRANT', 'domain': '2011D-41'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling', 'description': 'Lifestyle counseling. 6 group meetings,facilitated by community health worker, focusing on lifestyle change, eg, weight loss, physical activity, low salt, stress reduction', 'interventionNames': ['Behavioral: Lifestyle counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard care'}], 'interventions': [{'name': 'Lifestyle counseling', 'type': 'BEHAVIORAL', 'description': 'weight reduction, low salt, physical activity, stress reduction', 'armGroupLabels': ['Lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3522', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Lisbon Avenue Health Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53205', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Hillside Family Health Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Progressive Community Health Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Emeritus, Assoc Dean for Clinical Research', 'investigatorFullName': 'Theodore Kotchen, MD', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}