Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT00237692
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2005-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hypertension Intervention Nurse Telemedicine Study (HINTS)
Sponsor:
Organization:
Raw JSON
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Bosworth, PhD', 'phoneExt': '7107', 'organization': 'Center for Primary Care, HSRD COIN'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Overall length of study', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1- Control', 'description': 'A group of hypertensive patients who receive usual care', 'otherNumAtRisk': 147, 'otherNumAffected': 0, 'seriousNumAtRisk': 147, 'seriousNumAffected': 43}, {'id': 'EG001', 'title': 'Arm 2 - Nurse Behavioral Int', 'description': 'Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention', 'otherNumAtRisk': 148, 'otherNumAffected': 0, 'seriousNumAtRisk': 148, 'seriousNumAffected': 71}, {'id': 'EG002', 'title': 'Arm 3 - Nurse Med Managment Int', 'description': 'Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support', 'otherNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'seriousNumAffected': 68}, {'id': 'EG003', 'title': 'Arm 4 - Combined Behavioral and Med Mgmt Int', 'description': 'Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \\& medication management', 'otherNumAtRisk': 147, 'otherNumAffected': 0, 'seriousNumAtRisk': 147, 'seriousNumAffected': 60}], 'seriousEvents': [{'term': 'w/recurrent nosebleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer Tx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Circulatory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 18, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastro-Intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 30, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General - ER visits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General - Med-Refill', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General - Med Side Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Optometry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthopedic Issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 30, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary-Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary - Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Safety Protocol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 147, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Estimated Percentage of Participants in Blood Pressure Control at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '147', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1- Control', 'description': 'a group of hypertensive patients who receive usual care'}, {'id': 'OG001', 'title': 'Arm 2 - Nurse Behavioral Int', 'description': 'Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention'}, {'id': 'OG002', 'title': 'Arm 3 - Nurse Med Management Int', 'description': 'Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support'}, {'id': 'OG003', 'title': 'Arm 4 - Combined Behaviorial and Med Mgmt Int', 'description': 'Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \\& medication management'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.8', 'ciLowerLimit': '55.7', 'ciUpperLimit': '63.9', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled Systolic BP at Baseline', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Est. % of patients with controled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.8', 'ciLowerLimit': '55.7', 'ciUpperLimit': '64.0', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled Systolic BP at Baseline', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Est. % of patinets with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.8', 'ciLowerLimit': '55.6', 'ciUpperLimit': '63.9', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled BP at Baseline', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.8', 'ciLowerLimit': '55.6', 'ciUpperLimit': '63.9', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled Systolic BP at Baseline', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'When patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \\<140/90mmHg for non-diabetic patients and \\< 130/80mmHg for diabetic patients', 'unitOfMeasure': '% of particpants w/ controlled BP', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Estimated Percentage of Participants in Blood Pressure Control at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1- Control', 'description': 'a group of hypertensive patients who receive usual care'}, {'id': 'OG001', 'title': 'Arm 2 - Nurse Behavioral Int', 'description': 'Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention'}, {'id': 'OG002', 'title': 'Arm 3 - Nurse Med Management Int', 'description': 'Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support'}, {'id': 'OG003', 'title': 'Arm 4 - Combined Behaviorial and Med Mgmt Int', 'description': 'Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \\& medication management'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.0', 'ciLowerLimit': '49.3', 'ciUpperLimit': '66.7', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled Systolic BP at 6 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.9', 'ciLowerLimit': '52.5', 'ciUpperLimit': '69.3', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled systolic BP at 6 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '65.0', 'ciLowerLimit': '56.9', 'ciUpperLimit': '73.1', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled systolic BP at 6 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '63.8', 'ciLowerLimit': '55.6', 'ciUpperLimit': '72.0', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled systolic BP at 6 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': '% diff', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '14.9', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 6months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': '% Diff', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.9', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '18.7', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Med Management and Arm 1 - Control at 6months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': '% Diff', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '17.6', 'groupDescription': 'Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Combined Behavioral \\& Med Mgmt and Arm 1 - Control at 6months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6month', 'description': 'When patients had multiple blood pressure readings during their 6 month visit, means of their systolic and diastolic readings were used as the 6 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \\<140/90mmHg for non-diabetic patients and \\< 130/80mmHg for diabetic patients', 'unitOfMeasure': '% of particpants with controlled SBP', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Estimated Percentage of Participants in Blood Pressure Control at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1- Control', 'description': 'a group of hypertensive patients who receive usual care'}, {'id': 'OG001', 'title': 'Arm 2 - Nurse Behavioral Int', 'description': 'Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention'}, {'id': 'OG002', 'title': 'Arm 3 - Nurse Med Management Int', 'description': 'Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support'}, {'id': 'OG003', 'title': 'Arm 4 - Combined Behaviorial and Med Mgmt Int', 'description': 'Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \\& medication management'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.9', 'ciLowerLimit': '51.4', 'ciUpperLimit': '68.3', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled systolic BP at 12 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.1', 'ciLowerLimit': '65.6', 'ciUpperLimit': '80.7', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled systolic BP at 12 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.4', 'ciLowerLimit': '66.1', 'ciUpperLimit': '80.7', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled systolic BP at 12 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.6', 'ciLowerLimit': '60.5', 'ciUpperLimit': '76.6', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled Systolic BP at 12 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': '% Diff', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.2', 'ciLowerLimit': '2.0', 'ciUpperLimit': '24.4', 'groupDescription': 'Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 12 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': '% Diff', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.5', 'ciLowerLimit': '2.4', 'ciUpperLimit': '24.6', 'groupDescription': 'Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 12 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': '% diff', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.6', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '20.2', 'groupDescription': 'Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \\& Med Mgmt and Arm 1 - Control at 12 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'description': 'When patients had multiple blood pressure readings during their 12 month visit, means of their systolic and diastolic readings were used as the 12 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \\<140/90mmHg for non-diabetic patients and \\< 130/80mmHg for diabetic patients', 'unitOfMeasure': '% of particpants with controlled SBP', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Estimated Percentage of Participants in Blood Pressure Control at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1- Control', 'description': 'a group of hypertensive patients who receive usual care'}, {'id': 'OG001', 'title': 'Arm 2 - Nurse Behavioral Int', 'description': 'Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention'}, {'id': 'OG002', 'title': 'Arm 3 - Nurse Med Management Int', 'description': 'Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support'}, {'id': 'OG003', 'title': 'Arm 4 - Combined Behaviorial and Med Mgmt Int', 'description': 'Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \\& medication management'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '61.8', 'ciLowerLimit': '53.0', 'ciUpperLimit': '70.6', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled Systolic BP at 18 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.4', 'ciLowerLimit': '50.8', 'ciUpperLimit': '67.9', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled BP at 18 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '63.5', 'ciLowerLimit': '55.1', 'ciUpperLimit': '72.0', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled systolic BP at 18 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Est. % of Patients with controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '71.6', 'ciLowerLimit': '63.7', 'ciUpperLimit': '79.5', 'estimateComment': 'Joint National Committee 7 blood pressure control: \\< 140/90 mmHg for non-diabetics; \\<130/80 mmHg for diabetics', 'groupDescription': 'Estimated % of participants with controlled systolic BP at 18 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': '% Diff', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-14.6', 'ciUpperLimit': '9.7', 'groupDescription': 'Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 18 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': '% Diff', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '13.8', 'groupDescription': 'Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 18 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': '% Diff', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '21.4', 'groupDescription': 'Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \\& Med Mgmt and Arm 1 - Control at 18 months.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 month', 'description': 'When patients had multiple blood pressure readings during their 18 month visit, means of their systolic and diastolic readings were used as the 18 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \\<140/90mmHg for non-diabetic patients and \\< 130/80mmHg for diabetic patients', 'unitOfMeasure': '% of particpants with controlled SBP', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Pressure Averages Systolic & Diastolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '147', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1- Control', 'description': 'a group of hypertensive patients who receive usual care'}, {'id': 'OG001', 'title': 'Arm 2 - Nurse Behavioral Int', 'description': 'Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention'}, {'id': 'OG002', 'title': 'Arm 3 - Nurse Med Management Int', 'description': 'Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support'}, {'id': 'OG003', 'title': 'Arm 4 - Combined Behaviorial and Med Mgmt Int', 'description': 'Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \\& medication management'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '128', 'spread': '17', 'groupId': 'OG000'}, {'value': '129', 'spread': '19', 'groupId': 'OG001'}, {'value': '132', 'spread': '21', 'groupId': 'OG002'}, {'value': '127', 'spread': '21', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '78', 'spread': '14', 'groupId': 'OG000'}, {'value': '77', 'spread': '12', 'groupId': 'OG001'}, {'value': '78', 'spread': '14', 'groupId': 'OG002'}, {'value': '77', 'spread': '13', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Blood pressure measured at Baseline.\n\nBP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Pressure Averages Systolic & Diastolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1- Control', 'description': 'a group of hypertensive patients who receive usual care'}, {'id': 'OG001', 'title': 'Arm 2 - Nurse Behavioral Int', 'description': 'Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention'}, {'id': 'OG002', 'title': 'Arm 3 - Nurse Med Management Int', 'description': 'Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support'}, {'id': 'OG003', 'title': 'Arm 4 - Combined Behaviorial and Med Mgmt Int', 'description': 'Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \\& medication management'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '127.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '125.0', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '124.7', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '122.8', 'spread': '1.5', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '75.6', 'spread': '.9', 'groupId': 'OG000'}, {'value': '74.9', 'spread': '.9', 'groupId': 'OG001'}, {'value': '74.6', 'spread': '.9', 'groupId': 'OG002'}, {'value': '75.6', 'spread': '.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Est. % Diff in Patient w/Controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '7.1', 'estimateComment': 'Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.', 'groupDescription': 'Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Est. Dif in Patient w/Controlled DBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.5', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '3.8', 'estimateComment': 'Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.', 'groupDescription': 'Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Est. % Diff in Patient w/Controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '5.5', 'estimateComment': 'Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.', 'groupDescription': 'Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nurse Med Management.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Est. % Diff in Patient w/Controlled DBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '4.0', 'estimateComment': 'Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.', 'groupDescription': 'Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nuse Med Management', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Est. % Diff in Patient w/Controlled SBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '6.6', 'estimateComment': 'Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.', 'groupDescription': 'Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Est. % Diff in Patient w/Controlled DBP', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '0.3', 'ciUpperLimit': '6.6', 'estimateComment': 'Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.', 'groupDescription': 'Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12-month', 'description': 'Blood pressure measured at 12 month.\n\nBP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1- Control', 'description': 'A group of hypertensive patients who receive usual care'}, {'id': 'FG001', 'title': 'Arm 2 - Nurse Behavioral Int', 'description': 'Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention'}, {'id': 'FG002', 'title': 'Arm 3 - Nurse Med Managment Int', 'description': 'Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support'}, {'id': 'FG003', 'title': 'Arm 4 - Combined Behavioral and Med Mgmt Int', 'description': 'Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \\& medication management'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '149'}, {'groupId': 'FG003', 'numSubjects': '147'}]}, {'type': '6 Month f/u', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '135'}, {'groupId': 'FG003', 'numSubjects': '134'}]}, {'type': '12 Month f/u', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '132'}, {'groupId': 'FG003', 'numSubjects': '127'}]}, {'type': '18 Month f/u', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '126'}, {'groupId': 'FG003', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '127'}, {'groupId': 'FG003', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Excluded - did not meet criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}, {'value': '591', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1- Control', 'description': 'A group of hypertensive patients who receive usual care'}, {'id': 'BG001', 'title': 'Arm 2 - Nurse Behavioral Int', 'description': 'Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention'}, {'id': 'BG002', 'title': 'Arm 3 - Nurse Med Managment Int', 'description': 'Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support'}, {'id': 'BG003', 'title': 'Arm 4 - Combined Behavioral and Med Mgmt Int', 'description': 'Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \\& medication management'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '10', 'groupId': 'BG000'}, {'value': '63', 'spread': '11', 'groupId': 'BG001'}, {'value': '64', 'spread': '10', 'groupId': 'BG002'}, {'value': '63', 'spread': '11', 'groupId': 'BG003'}, {'value': '64', 'spread': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}, {'value': '542', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '289', 'groupId': 'BG004'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '285', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}, {'value': '591', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All data except blood pressure, age, gender were patient-reported.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 591}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2005-10-07', 'resultsFirstSubmitDate': '2014-08-29', 'studyFirstSubmitQcDate': '2005-10-07', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-21', 'studyFirstPostDateStruct': {'date': '2005-10-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated Percentage of Participants in Blood Pressure Control at Baseline', 'timeFrame': 'Baseline', 'description': 'When patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \\<140/90mmHg for non-diabetic patients and \\< 130/80mmHg for diabetic patients'}, {'measure': 'Estimated Percentage of Participants in Blood Pressure Control at 6 Months', 'timeFrame': '6month', 'description': 'When patients had multiple blood pressure readings during their 6 month visit, means of their systolic and diastolic readings were used as the 6 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \\<140/90mmHg for non-diabetic patients and \\< 130/80mmHg for diabetic patients'}, {'measure': 'Estimated Percentage of Participants in Blood Pressure Control at 12 Months', 'timeFrame': '12 month', 'description': 'When patients had multiple blood pressure readings during their 12 month visit, means of their systolic and diastolic readings were used as the 12 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \\<140/90mmHg for non-diabetic patients and \\< 130/80mmHg for diabetic patients'}, {'measure': 'Estimated Percentage of Participants in Blood Pressure Control at 18 Months', 'timeFrame': '18 month', 'description': 'When patients had multiple blood pressure readings during their 18 month visit, means of their systolic and diastolic readings were used as the 18 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \\<140/90mmHg for non-diabetic patients and \\< 130/80mmHg for diabetic patients'}, {'measure': 'Blood Pressure Averages Systolic & Diastolic', 'timeFrame': 'Baseline', 'description': 'Blood pressure measured at Baseline.\n\nBP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.'}, {'measure': 'Blood Pressure Averages Systolic & Diastolic', 'timeFrame': '12-month', 'description': 'Blood pressure measured at 12 month.\n\nBP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'Adherence', 'Tailored Nurse Intervention', 'Home Blood Pressure Monitoring', 'cardiovascular disease'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '17540191', 'type': 'BACKGROUND', 'citation': 'Bosworth HB, Olsen MK, McCant F, Harrelson M, Gentry P, Rose C, Goldstein MK, Hoffman BB, Powers B, Oddone EZ. Hypertension Intervention Nurse Telemedicine Study (HINTS): testing a multifactorial tailored behavioral/educational and a medication management intervention for blood pressure control. Am Heart J. 2007 Jun;153(6):918-24. doi: 10.1016/j.ahj.2007.03.004.'}, {'pmid': '22926634', 'type': 'RESULT', 'citation': 'Crowley MJ, Grubber JM, Olsen MK, Bosworth HB. Factors associated with non-adherence to three hypertension self-management behaviors: preliminary data for a new instrument. J Gen Intern Med. 2013 Jan;28(1):99-106. doi: 10.1007/s11606-012-2195-1. Epub 2012 Aug 28.'}, {'pmid': '22865016', 'type': 'RESULT', 'citation': 'Jackson GL, Oddone EZ, Olsen MK, Powers BJ, Grubber JM, McCant F, Bosworth HB. Racial differences in the effect of a telephone-delivered hypertension disease management program. J Gen Intern Med. 2012 Dec;27(12):1682-9. doi: 10.1007/s11606-012-2138-x. Epub 2012 Aug 3.'}, {'pmid': '22709750', 'type': 'RESULT', 'citation': 'Wang V, Smith VA, Bosworth HB, Oddone EZ, Olsen MK, McCant F, Powers BJ, Van Houtven CH. Economic evaluation of telephone self-management interventions for blood pressure control. Am Heart J. 2012 Jun;163(6):980-6. doi: 10.1016/j.ahj.2012.03.016. Epub 2012 May 21.'}, {'pmid': '21844490', 'type': 'RESULT', 'citation': 'Crowley MJ, Smith VA, Olsen MK, Danus S, Oddone EZ, Bosworth HB, Powers BJ. Treatment intensification in a hypertension telemanagement trial: clinical inertia or good clinical judgment? Hypertension. 2011 Oct;58(4):552-8. doi: 10.1161/HYPERTENSIONAHA.111.174367. Epub 2011 Aug 15.'}, {'pmid': '21747013', 'type': 'RESULT', 'citation': 'Bosworth HB, Powers BJ, Olsen MK, McCant F, Grubber J, Smith V, Gentry PW, Rose C, Van Houtven C, Wang V, Goldstein MK, Oddone EZ. Home blood pressure management and improved blood pressure control: results from a randomized controlled trial. Arch Intern Med. 2011 Jul 11;171(13):1173-80. doi: 10.1001/archinternmed.2011.276.'}, {'pmid': '21690592', 'type': 'RESULT', 'citation': 'Powers BJ, Olsen MK, Smith VA, Woolson RF, Bosworth HB, Oddone EZ. Measuring blood pressure for decision making and quality reporting: where and how many measures? Ann Intern Med. 2011 Jun 21;154(12):781-8, W-289-90. doi: 10.7326/0003-4819-154-12-201106210-00005.'}, {'pmid': '21473965', 'type': 'RESULT', 'citation': 'Powers BJ, Danus S, Grubber JM, Olsen MK, Oddone EZ, Bosworth HB. The effectiveness of personalized coronary heart disease and stroke risk communication. Am Heart J. 2011 Apr;161(4):673-80. doi: 10.1016/j.ahj.2010.12.021.'}, {'pmid': '23625207', 'type': 'RESULT', 'citation': 'Zullig LL, Melnyk SD, Goldstein K, Shaw RJ, Bosworth HB. The role of home blood pressure telemonitoring in managing hypertensive populations. Curr Hypertens Rep. 2013 Aug;15(4):346-55. doi: 10.1007/s11906-013-0351-6.'}, {'pmid': '24088280', 'type': 'RESULT', 'citation': 'Bowen ME, Bosworth HB, Roumie CL. Blood pressure control in a hypertension telemedicine intervention: does distance to primary care matter? J Clin Hypertens (Greenwich). 2013 Oct;15(10):723-30. doi: 10.1111/jch.12172. Epub 2013 Jul 23.'}, {'pmid': '19249414', 'type': 'RESULT', 'citation': 'Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK, McCant F, Gentry P, Simel DL, Oddone EZ. Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial. Am Heart J. 2009 Mar;157(3):450-6. doi: 10.1016/j.ahj.2008.11.003. Epub 2009 Jan 10.'}, {'pmid': '19720764', 'type': 'RESULT', 'citation': 'McCant F, McKoy G, Grubber J, Olsen MK, Oddone E, Powers B, Bosworth HB. Feasibility of blood pressure telemonitoring in patients with poor blood pressure control. J Telemed Telecare. 2009;15(6):281-5. doi: 10.1258/jtt.2009.090202.'}, {'pmid': '24619321', 'type': 'DERIVED', 'citation': 'Maciejewski ML, Bosworth HB, Olsen MK, Smith VA, Edelman D, Powers BJ, Kaufman MA, Oddone EZ, Jackson GL. Do the benefits of participation in a hypertension self-management trial persist after patients resume usual care? Circ Cardiovasc Qual Outcomes. 2014 Mar;7(2):269-75. doi: 10.1161/CIRCOUTCOMES.113.000309. Epub 2014 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under effective control (less than 140/90 mm/Hg). Uncontrolled hypertension greatly increases the risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension and the availability of well-defined therapies and widely accepted target values for BP, interventions to improve BP control have had limited success.', 'detailedDescription': "Detailed\n\nDescription Background:\n\nThere are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under effective control (\\<140/90 mm/Hg). Uncontrolled hypertension greatly increases the risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension and the availability of well-defined therapies and widely accepted target values for BP, interventions to improve BP control have had limited success.\n\nObjectives:\n\nThe study is one of the first to compare three interventions designed to improve BP control: a behavioral educational intervention, an evidence-based medication management intervention, and combined intervention for patients with poor BP control defined by home BP monitoring. The primary hypotheses are: 1) Patients who receive only the behavioral intervention will show improved rates of BP control as compared to the control group over 18 months of follow-up; 2) Patients who receive only the hypertension medication management intervention will show improved rates of BP control as compared to the control group over 18 months of follow-up; and, 3) Patients who receive the combined intervention will show higher rates of BP control as compared to all other patients over the 18 months of follow-up.\n\nMethods:\n\nA three-year randomized controlled trial among veterans with poor BP control testing three interventions in three VA primary care clinics is proposed to improve BP control. We will test these interventions using home BP monitoring in a four group design administered via the telephone: 1) control group - a group of hypertensive patients who receive usual care; 2) Nurse-administered tailored behavioral intervention previously tested (HSR\\&D grant IIR 20-034); 3) Nurse-administered medication management according to a hypertension decision support system that uses the VA's Computerized Medical Record System (VA HSR\\&D grant CPI 99275); 4) combination of the tailored behavioral and medication management interventions.\n\nA random sample of hypertensive patients with poor BP control at baseline were consented and randomly allocated to one of four arms. The interventions will activate only when home BP monitoring indicates inadequate BP control. Patients assigned to the behavioral intervention will receive a tailored self-management intervention to promote adherence with medication, information on the risks of hypertension and health behaviors at periodic telephone contacts. Patients will receive feedback about their recent BP values, continuous patient education, and will be monitored and supported to enhance treatment adherence. Patients randomized to the medication management arm will have their hypertension regimen changed by a nurse using a hypertension decision support system developed and validated in the VA. Medication recommendations generated are based on JNC 7 and the VA's hypertension treatment guidelines and are also individualized to patients' comorbid illnesses, laboratory values, and other elements of patients' clinical status. Medication management will be based on home BP monitoring and delivered by telephone. The nurse is part of an extended primary care team and communicates changes to the patients' primary care providers via a study physician.\n\nThe primary outcome will be a dichotomous measure representing whether or not the patient's BP is in control: \\>140/90 mm/Hg (non-diabetic) and \\>130/80 mm/Hg (diabetics). Measures will be made at six-month intervals over 18 months (4 total measurements). We will model the outcome measures and evaluate the interventions using a mixed effects model for dichotomous outcomes.\n\nStatus:\n\nPrimary study enrollment began May 5, 2006 and was completed November 2007. We randomized 591 participants in the study. Baseline recruitment was completed in November 2007. Participants' completed the six month follow-up interviews in June 2008 and 12 month follow-up in December 2008. 18 month follow-up was completed June 2009.\n\nStudy was granted an extension to complete two goals: 1) investigate the sustainability of BP control after completion of intervention, and , 2) examine what aspects of the intervention worked or did not work using qualitative interviews.\n\nBackground/Rationale:\n\nDespite the impact of hypertension and the availability of well-defined therapies and widely accepted target values for blood pressure (BP), interventions to improve BP control have had limited success.\n\nObjectives:\n\nThe study is one of the first to compare three interventions designed to improve BP control: a behavioral educational intervention, an evidence-based medication management intervention, and combined intervention for patients with poor BP control defined by home BP monitoring. We received an 11 month extension to evaluate 3 key components of the study (sustainability of BP effects, qualitative evaluation of the intervention, evaluation of the supporting materials used to ensure literacy levels and cultural sensitivity.)\n\nMethods:\n\nA 4-arm randomized trial with 18-month follow-up. Patents were selected from primary care clinics at the Durham VA Medical Center. Of the eligible patients, 591 individuals were randomized to either usual care or one of three telephone-based intervention groups. The intervention phone calls were triggered based on home BP values transmitted via telemonitoring devices. Patients were instructed to take their BP three times a week and transmit to study team. Behavioral management involved promoting health behaviors. Medication management involved adjustment of hypertension medications by a study physician and nurse based on hypertension treatment guidelines. The primary outcome was changes in BP control measured at six-month intervals over 18 months. For the sustainability extension of the study, in additional to collection of BP values, we will use qualitative analysis to examine the audio interviews.\n\nStatus:\n\nSustainability phase recruitment began May 1, 2010 and ended on Aug 15, 2010. Analyses are continuing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of uncontrolled hypertension,\n* prescribed a medication to lower blood pressure,\n* have a regular primary care physician at Durham VA Medical Center, and\n* be a veteran. For Sustainability portion the patient must have participated in an intervention arm of primary study.\n\nExclusion Criteria:\n\n* Hospitalized in past 3 months for stroke,\n* heart attack,\n* surgery for blocked arteries,\n* diagnosed with metastatic cancer or treated with dialysis,\n* have a diagnosis of dementia or a hearing impairment which prevents them from being able to hear/speak on the telephone, and\n* creatinine serum lab which exceed 2.5.'}, 'identificationModule': {'nctId': 'NCT00237692', 'briefTitle': 'Hypertension Intervention Nurse Telemedicine Study (HINTS)', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Behavioral/Pharmacological Telemedicine Interventions for BP Control', 'orgStudyIdInfo': {'id': 'IIR 04-426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm 1', 'description': 'Control group - a group of hypertensive patient who receive usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Nurse Behavioral intervention with Home BP Telemonitoring Nurse-administered tailored behavior intervention', 'interventionNames': ['Behavioral: Nurse Behavioral intervention with Home BP Telemonitoring']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Nurse Medication Management with Home BP Telemonitoring -- Nurse administer medication management according to hypertension decision support system', 'interventionNames': ['Behavioral: Nurse Medication Management with Home BP Telemonitoring']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'Nurse Combined intervention with Home BP Telemonitoring - Combination of the nurse administered tailored behavioral \\& medication management interventions', 'interventionNames': ['Behavioral: Nurse Combined intervention with Home BP Telemonitoring']}], 'interventions': [{'name': 'Nurse Behavioral intervention with Home BP Telemonitoring', 'type': 'BEHAVIORAL', 'description': 'Nurse-administered behavior intervention', 'armGroupLabels': ['Arm 2']}, {'name': 'Nurse Medication Management with Home BP Telemonitoring', 'type': 'BEHAVIORAL', 'description': 'Nurse administer medication management according to hypertension decision support', 'armGroupLabels': ['Arm 3']}, {'name': 'Nurse Combined intervention with Home BP Telemonitoring', 'type': 'BEHAVIORAL', 'description': 'Combination of the nurse administered tailored behavioral \\& medication management', 'armGroupLabels': ['Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Hayden B. Bosworth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durham VA Medical Center, Durham, NC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}