Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-04 @ 4:34 PM
Study NCT ID:
NCT03158051
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Young Adult Hypertension Self-Management Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'khoppe2@wisc.edu', 'phone': '608-417-4224', 'title': 'Kara Hoppe, DO', 'organization': 'University of Wisconsin School of Medicine and Public Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 13 months', 'description': 'Participants were asked about Adverse Events (AE) during all in-person visits and by phone in the follow-up call. Participants in the intervention arm were asked about ER, urgent care, hospitalizations, and blood pressure-related symptoms during health coach calls.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 56, 'seriousNumAtRisk': 157, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 38, 'seriousNumAtRisk': 159, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Endocrine disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Gastrointestinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Immune system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Infections and infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Metabolism and nutrition disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Nervous system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Renal and urinary disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Reproductive system and breast disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Skin and subcutaneous tissue disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Social circumstances - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vascular disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Cardiac disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'General disorders and administration site conditions - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Injury, poisoning and procedural complications - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Psychiatric disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'seriousEvents': [{'term': 'Cardiac disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Chest Wall Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vascular disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Musculoskeletal and connective tissue disorder - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '24-hour Systolic Ambulatory Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '132.59', 'spread': '11.36', 'groupId': 'OG000'}, {'value': '133.01', 'spread': '12.67', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128.14', 'spread': '11.36', 'groupId': 'OG000'}, {'value': '130.69', 'spread': '13.99', 'groupId': 'OG001'}]}]}, {'title': '12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128.54', 'spread': '11.95', 'groupId': 'OG000'}, {'value': '129.47', 'spread': '14.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': '24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'PRIMARY', 'title': '24-hour Diastolic Ambulatory Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.45', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '87.04', 'spread': '8.16', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.61', 'spread': '8.24', 'groupId': 'OG000'}, {'value': '85.89', 'spread': '9.19', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.34', 'spread': '9.32', 'groupId': 'OG000'}, {'value': '85.52', 'spread': '9.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': '24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'PRIMARY', 'title': 'Clinic Systolic Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '138.30', 'spread': '14.27', 'groupId': 'OG000'}, {'value': '137.97', 'spread': '14.33', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.84', 'spread': '12.16', 'groupId': 'OG000'}, {'value': '132.50', 'spread': '15.83', 'groupId': 'OG001'}]}]}, {'title': '12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.16', 'spread': '12.77', 'groupId': 'OG000'}, {'value': '130.7', 'spread': '15.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Systolic Blood Pressure measured at baseline, 6 months, and 12 months.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'PRIMARY', 'title': 'Clinic Diastolic Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.81', 'spread': '11.42', 'groupId': 'OG000'}, {'value': '91.77', 'spread': '11.26', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.83', 'spread': '9.36', 'groupId': 'OG000'}, {'value': '86.70', 'spread': '12.44', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.05', 'spread': '10.56', 'groupId': 'OG000'}, {'value': '85.15', 'spread': '12.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Achieve Hypertension Control at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': '24-hour Ambulatory Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Clinic Measured Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 months', 'description': 'Hypertension Control: Percentage of participants that achieve hypertension control at 6 months. Hypertension control will be defined using ambulatory blood pressures as the gold standard (\\<130/80 mmHg); otherwise a clinic blood pressure of \\<140/90 mmHg will be used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician, 2 participants in the Usual clinical care arm did not wear their cuff long enough to get adequate readings for AMBP'}, {'type': 'SECONDARY', 'title': 'Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3512.82', 'spread': '1765.59', 'groupId': 'OG000'}, {'value': '3672.81', 'spread': '1812.82', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3354.72', 'spread': '1365.75', 'groupId': 'OG000'}, {'value': '3968.20', 'spread': '1725.17', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3682.94', 'spread': '1874.53', 'groupId': 'OG000'}, {'value': '4213.67', 'spread': '1972.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Mean daily sodium intake (milligrams/day) at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment', 'unitOfMeasure': 'milligrams per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.34', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '1.98', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.43', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '1.89', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.50', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '2.55', 'spread': '1.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Mean number of combined fruit and vegetable servings measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in cups equivalent.', 'unitOfMeasure': 'cups per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '1.62', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '2.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Ounces of whole grain measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment', 'unitOfMeasure': 'ounces per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.91', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '12.54', 'spread': '4.32', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.97', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '13.12', 'spread': '6.56', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.03', 'spread': '4.72', 'groupId': 'OG000'}, {'value': '13.46', 'spread': '4.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Saturated fat measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in percent kilocalories', 'unitOfMeasure': 'percent kilocalories', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Physical Activity as Assessed by the Godin Physical Activity Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.24', 'spread': '31.51', 'groupId': 'OG000'}, {'value': '37.24', 'spread': '26.99', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.47', 'spread': '61.99', 'groupId': 'OG000'}, {'value': '40.69', 'spread': '31.80', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.67', 'spread': '46.10', 'groupId': 'OG000'}, {'value': '39.22', 'spread': '25.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': "Mean weekly amounts of physical activity as assessed by the Godin Physical Activity Questionnaire. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. Scoring is calculated as follows (units are times per week that the participant engaged in any of the 3 classifications of activity longer than 15 minutes during their free time):\n\n* 9 x strenous units reported + 5 x moderate units reported + 3 x light units reported = score\n\nA minimum score of 0 indicates no activity, a score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active, a theoretical maximum does not exist.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Home Blood Pressure Monitoring Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Not on a regular basis', 'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}, {'title': 'At least once per month', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'At least once a week', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'At least once a day', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Not on a regular basis', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'title': 'At least once per month', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'At least once a week', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'At least once a day', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Not on a regular basis', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'title': 'At least once per month', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'At least once a week', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'At least once a day', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Self-report of home blood pressure monitoring frequency measured at baseline, 6 months, and 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Standing Weight (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '102.86', 'spread': '28.64', 'groupId': 'OG000'}, {'value': '102.93', 'spread': '27.30', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.54', 'spread': '26.19', 'groupId': 'OG000'}, {'value': '103.80', 'spread': '25.34', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.91', 'spread': '26.07', 'groupId': 'OG000'}, {'value': '103.45', 'spread': '25.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Weight (kg) measured at baseline, 6 months, and 12 months.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Perceived Competence as Assessed by the Perceived Competence Scale for Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.54', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '1.30', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.04', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.71', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '4.70', 'spread': '1.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Perceived Competence as Assessed by the Perceived Competence Scale for Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.83', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '5.03', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.28', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '5.01', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.98', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '4.89', 'spread': '1.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.63', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '4.93', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.35', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '5.17', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.06', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.72', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.31', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '5.17', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.11', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '5.31', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.80', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '5.80', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.86', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '5.76', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.78', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '5.85', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.81', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '5.81', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.94', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '5.74', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.79', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.19', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '3.04', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.30', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.36', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '3.39', 'spread': '1.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.20', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.28', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.17', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '3.28', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.30', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.29', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '2.45', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.47', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'SECONDARY', 'title': 'Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'OG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.27', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.27', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.55', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants lost to follow up, withdrew, and/or removed from study per physician'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health Coach Fidelity to the Study Intervention', 'timeFrame': 'through completion of administering the study intervention, an average of 4 years', 'description': 'Evaluation of health coach fidelity to administering the motivational interviewing intervention per protocol will be assessed every 2 months using a modified Behavior Change Counseling Index', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Number and type of adverse events', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serious Adverse Events', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Number and type of serious adverse events', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Withdrawal', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Subject Withdrawal Rate', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials\n\nHome Blood Pressure Monitoring: Intervention arm participants will receive a home blood pressure monitor, home blood pressure log, and training on accurate home monitoring. They will be asked to share their home blood pressure readings during health coach telephone calls.\n\nTelephone Health Coaching: Intervention arm participants will receive a health coach phone call every 2 weeks for 6 months, for a total of 12 calls. During each call, the health coach will review and discuss home blood pressures and address barriers and concerns to hypertension management. During each telephone call, the coach will guide the participant on selecting health behavior goals. Intervention arm participants will also receive handouts about hypertension management during the study visits and after health coach calls.'}, {'id': 'FG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'Visit 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'Visit 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'Visit 5', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'Visit 6', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials.'}, {'id': 'BG001', 'title': 'Usual Clinical Care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'groupId': 'BG000', 'lowerLimit': '18.0', 'upperLimit': '39.0'}, {'value': '33.7', 'groupId': 'BG001', 'lowerLimit': '19.0', 'upperLimit': '39.0'}, {'value': '33.8', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '39.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Beverages per week', 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '25.0'}, {'value': '5.1', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '32.0'}, {'value': '5.2', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '32.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'servings of alcohol per week', 'dispersionType': 'FULL_RANGE'}, {'title': 'Ambulatory Diastolic Blood Pressure (BP)', 'classes': [{'categories': [{'measurements': [{'value': '86.5', 'groupId': 'BG000', 'lowerLimit': '68.0', 'upperLimit': '110.0'}, {'value': '87.0', 'groupId': 'BG001', 'lowerLimit': '72.0', 'upperLimit': '120.0'}, {'value': '86.7', 'groupId': 'BG002', 'lowerLimit': '68.0', 'upperLimit': '120.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Ambulatory Systolic BP', 'classes': [{'categories': [{'measurements': [{'value': '132.6', 'groupId': 'BG000', 'lowerLimit': '108.0', 'upperLimit': '172.0'}, {'value': '133.0', 'groupId': 'BG001', 'lowerLimit': '112.0', 'upperLimit': '183.0'}, {'value': '132.8', 'groupId': 'BG002', 'lowerLimit': '108.0', 'upperLimit': '183.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'BG000', 'lowerLimit': '19.8', 'upperLimit': '63.1'}, {'value': '34.5', 'groupId': 'BG001', 'lowerLimit': '19.3', 'upperLimit': '57.8'}, {'value': '34.5', 'groupId': 'BG002', 'lowerLimit': '19.3', 'upperLimit': '63.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of Children at Home', 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '1.0', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '1.0', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'children', 'dispersionType': 'FULL_RANGE'}, {'title': 'Office Diastolic BP', 'classes': [{'categories': [{'measurements': [{'value': '90.8', 'groupId': 'BG000', 'lowerLimit': '68.7', 'upperLimit': '131.7'}, {'value': '91.8', 'groupId': 'BG001', 'lowerLimit': '66.0', 'upperLimit': '136.3'}, {'value': '91.3', 'groupId': 'BG002', 'lowerLimit': '66.0', 'upperLimit': '136.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Office Systolic BP', 'classes': [{'categories': [{'measurements': [{'value': '138.3', 'groupId': 'BG000', 'lowerLimit': '106.0', 'upperLimit': '185.3'}, {'value': '138.0', 'groupId': 'BG001', 'lowerLimit': '109.7', 'upperLimit': '192.0'}, {'value': '138.1', 'groupId': 'BG002', 'lowerLimit': '106.0', 'upperLimit': '192.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '109.5', 'groupId': 'BG000', 'lowerLimit': '65.0', 'upperLimit': '178.0'}, {'value': '109.4', 'groupId': 'BG001', 'lowerLimit': '66.0', 'upperLimit': '153.0'}, {'value': '109.4', 'groupId': 'BG002', 'lowerLimit': '65.0', 'upperLimit': '178.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '103.1', 'groupId': 'BG000', 'lowerLimit': '53.0', 'upperLimit': '206.0'}, {'value': '103.3', 'groupId': 'BG001', 'lowerLimit': '45.0', 'upperLimit': '200.0'}, {'value': '103.2', 'groupId': 'BG002', 'lowerLimit': '45.0', 'upperLimit': '206.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'FULL_RANGE'}, {'title': 'Cigarette Tobacco Status', 'classes': [{'categories': [{'title': 'Currently Smoke Cigarettes', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Have Never Smoked Cigarettes', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': 'Used to Smoke Cigarettes', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Godin-Shephard Physical Activity', 'classes': [{'categories': [{'title': 'Active', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Insufficiently Active', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest Level of Education', 'classes': [{'categories': [{'title': 'I have not finished High School', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'I have completed High School', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'I have not finished College or Vocational School', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'I have finished College or Vocational School', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Some / Completed Graduate of Professional School', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'categories': [{'title': 'Single', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Married / Partnered', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Divorced / Widower', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Antihypertensive Medications', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'greater than or equal to 4', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Self-Perceived Health Status', 'classes': [{'categories': [{'title': 'Excellent', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Very Good or Good', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'Fair', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Poor or No Response', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'Anxiety and / or Depression', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Kidney Disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Dyslipidemia', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Other Chronic Comorbidity', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Risk Factors', 'classes': [{'title': 'E-Cigarette / Vaping Use in the past 6 months', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Ever Been on Medicaid', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Family History of Heart Disease or Stroke', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}, {'title': 'Financial Status: Inadequate Income', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-04', 'size': 1664076, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-12T09:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2017-05-15', 'resultsFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-15', 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health Coach Fidelity to the Study Intervention', 'timeFrame': 'through completion of administering the study intervention, an average of 4 years', 'description': 'Evaluation of health coach fidelity to administering the motivational interviewing intervention per protocol will be assessed every 2 months using a modified Behavior Change Counseling Index'}, {'measure': 'Adverse Events', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Number and type of adverse events'}, {'measure': 'Serious Adverse Events', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Number and type of serious adverse events'}, {'measure': 'Withdrawal', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Subject Withdrawal Rate'}], 'primaryOutcomes': [{'measure': '24-hour Systolic Ambulatory Blood Pressure (mmHg)', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': '24-hour Systolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.'}, {'measure': '24-hour Diastolic Ambulatory Blood Pressure (mmHg)', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': '24-hour Diastolic Ambulatory Blood Pressure measured at baseline, 6 months, and 12 months.'}, {'measure': 'Clinic Systolic Blood Pressure (mmHg)', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Systolic Blood Pressure measured at baseline, 6 months, and 12 months.'}, {'measure': 'Clinic Diastolic Blood Pressure (mmHg)', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Clinic Diastolic Blood Pressure measured at baseline, 6 months, and 12 months.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants That Achieve Hypertension Control at 6 Months', 'timeFrame': 'up to 6 months', 'description': 'Hypertension Control: Percentage of participants that achieve hypertension control at 6 months. Hypertension control will be defined using ambulatory blood pressures as the gold standard (\\<130/80 mmHg); otherwise a clinic blood pressure of \\<140/90 mmHg will be used.'}, {'measure': 'Sodium Intake as Assessed by the Automated Self-Administered 24-hour Dietary Assessment', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Mean daily sodium intake (milligrams/day) at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment'}, {'measure': 'Number of Combined Fruit and Vegetable Servings as Assessed by the Automated Self-Administered 24-hour Dietary Assessment', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Mean number of combined fruit and vegetable servings measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in cups equivalent.'}, {'measure': 'Ounces of Whole Grain as Assessed by the Automated Self-Administered 24-hour Dietary Assessment', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Ounces of whole grain measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment'}, {'measure': 'Saturated Fat as Assessed by the Automated Self-Administered 24-hour Dietary Assessment', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Saturated fat measured at baseline, 6 months, and 12 months as assessed by the computer administered Automated Self-Administered 24-hour Dietary Assessment, reported in percent kilocalories'}, {'measure': 'Physical Activity as Assessed by the Godin Physical Activity Questionnaire', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': "Mean weekly amounts of physical activity as assessed by the Godin Physical Activity Questionnaire. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. Scoring is calculated as follows (units are times per week that the participant engaged in any of the 3 classifications of activity longer than 15 minutes during their free time):\n\n* 9 x strenous units reported + 5 x moderate units reported + 3 x light units reported = score\n\nA minimum score of 0 indicates no activity, a score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active, a theoretical maximum does not exist."}, {'measure': 'Home Blood Pressure Monitoring Frequency', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Self-report of home blood pressure monitoring frequency measured at baseline, 6 months, and 12 months.'}, {'measure': 'Standing Weight (kg)', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Weight (kg) measured at baseline, 6 months, and 12 months.'}, {'measure': 'Perceived Competence as Assessed by the Perceived Competence Scale for Diet', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence.'}, {'measure': 'Perceived Competence as Assessed by the Perceived Competence Scale for Exercise', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Perceived competence measured at baseline, 6 months, and 12 months as assessed by the Perceived Competence Scale (self-administration). This is a 4-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score from 1-7 will be reported with higher scores indicating increased perceived competence.'}, {'measure': 'Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Diet', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy.'}, {'measure': 'Perceived Autonomy as Assessed by the Health Care Climate Questionnaire for Exercise', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Perceived autonomy measured at baseline, 6 months, and 12 months as assessed by the Health Care Climate Questionnaire (self-administration). This is a 6-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean between 1-7 will be reported with higher scores indicative of increased perceived autonomy.'}, {'measure': 'Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation.'}, {'measure': 'Autonomous Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Autonomous motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased autonomous motivation.'}, {'measure': 'Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation.'}, {'measure': 'Controlled Motivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Controlled motivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased controlled motivation.'}, {'measure': 'Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Diet', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation.'}, {'measure': 'Amotivation as Assessed by the Treatment Self-Regulation Questionnaire for Exercise', 'timeFrame': 'baseline, 6 month, and 12 month follow-up', 'description': 'Amotivation measured at baseline, 6 months, and 12 months as assessed by the Treatment Self-Regulation Questionnaire (self-administration). This is a 15-item survey scored on a 7 point likert scale from 1 (not at all true) to 7 (very true). Mean score between 1 and 7 will be reported with higher scores indicative of increased amotivation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Young Adult', 'Self-Management', 'Health coach'], 'conditions': ['Hypertension', 'Blood Pressure', 'Lifestyle Risk Reduction']}, 'referencesModule': {'references': [{'pmid': '30677485', 'type': 'BACKGROUND', 'citation': 'Johnson HM, Sullivan-Vedder L, Kim K, McBride PE, Smith MA, LaMantia JN, Fink JT, Knutson Sinaise MR, Zeller LM, Lauver DR. Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial. Contemp Clin Trials. 2019 Mar;78:88-100. doi: 10.1016/j.cct.2019.01.010. Epub 2019 Jan 21.'}, {'pmid': '36735261', 'type': 'DERIVED', 'citation': 'Hoppe KK, Smith M, Birstler J, Kim K, Sullivan-Vedder L, LaMantia JN, Knutson Sinaise MR, Swenson M, Fink J, Haggart R, McBride P, Lauver DR, Johnson HM. Effect of a Telephone Health Coaching Intervention on Hypertension Control in Young Adults: The MyHEART Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255618. doi: 10.1001/jamanetworkopen.2022.55618.'}]}, 'descriptionModule': {'briefSummary': "This is a 5-year randomized controlled trial in two large healthcare systems (Madison and Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact on blood pressure among 310 geographically and racially/ethnically diverse young adults.", 'detailedDescription': "Aim 1. To evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary) and hypertension control (secondary) after 6 and 12 months, compared to usual clinical care.\n\nAim 2. To evaluate the effect of MyHEART on hypertension self-management behavior (behavioral outcomes) at 6 and 12 months, compared to usual clinical care.\n\nAim 3. To examine whether MyHEART's effects on self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and capable of giving written informed consent\n* Willing to comply with all study procedures and be available for the duration of the study\n* Males and females ages 18-39 years old at the start of the study (inclusive)\n* A minimum of two hypertension ICD-10 coded visits with a provider (physician \\[MD, DO\\], physician assistant, nurse practitioner) on different dates in the last 24 months, with at least one code in the past 18 months\n* Medically homed at an IRB approved healthcare system\n\nExclusion Criteria:\n\n* History of medically determined Congestive Heart Failure\n* Unable to provide informed consent (i.e., activated healthcare power of attorney)\n* Unable or unwilling to travel to local clinic for research visits\n* Currently residing in a skilled nursing facility\n* Diagnosed with sickle cell anemia or cystic fibrosis\n* Diagnosed with stroke, myocardial infarction, and/or coronary artery revascularization in the past 2 years\n* Syncope while exercising or doing strenuous activity within past 12 months\n* Currently prescribed warfarin, novel oral anticoagulant, or insulin\n* Planned organ transplant or prior transplant in the past 5 years\n* Chemotherapy or radiation therapy within 6 the past months\n* Severely impaired hearing, vision, or speech, as determined by study staff responsible for enrollment\n* Current participation or planning to participate in another clinical trial in the next 12 months\n* Pregnant or planning to become pregnant in the next 12 months\n* Planning to leave the geographic area in the next 6 months\n* Health condition that will limit both increasing physical activity and changing diet\n* Illegal drug use (other than marijuana) in the past 30 days\n* Unable to read or communicate in English\n* Currently on dialysis or seeing a Nephrologist\n* Unaware or denies history of high blood pressure or hypertension\n* Between-arm blood pressure difference \\>20 mmHg\n* White Coat Hypertension (24-hour ambulatory monitoring)\n* Inability to comply with or complete the protocol or other reasons at the discretion of the principal and site investigators\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT03158051', 'acronym': 'MyHEART', 'briefTitle': 'Young Adult Hypertension Self-Management Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'The MyHEART Study: A Young Adult Hypertension Self-Management Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2017-0372'}, 'secondaryIdInfos': [{'id': 'R01HL132148', 'link': 'https://reporter.nih.gov/quickSearch/R01HL132148', 'type': 'NIH'}, {'id': 'A534225', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\MEDICINE\\CARDIOLOGY', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Telephone health coaching, home blood pressure monitoring, individualized goal setting, and tailored educational materials', 'interventionNames': ['Behavioral: Home Blood Pressure Monitoring', 'Behavioral: Telephone Health Coaching']}, {'type': 'NO_INTERVENTION', 'label': 'Usual clinical care', 'description': 'Usual care arm participants will receive routine hypertension clinical care per their primary care provider.'}], 'interventions': [{'name': 'Home Blood Pressure Monitoring', 'type': 'BEHAVIORAL', 'description': 'Intervention arm participants will receive a home blood pressure monitor, home blood pressure log, and training on accurate home monitoring. They will be asked to share their home blood pressure readings during health coach telephone calls.', 'armGroupLabels': ['Intervention']}, {'name': 'Telephone Health Coaching', 'type': 'BEHAVIORAL', 'description': 'Intervention arm participants will receive a health coach phone call every 2 weeks for 6 months, for a total of 12 calls. During each call, the health coach will review and discuss home blood pressures and address barriers and concerns to hypertension management. During each telephone call, the coach will guide the participant on selecting health behavior goals. Intervention arm participants will also receive handouts about hypertension management during the study visits and after health coach calls.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin School of Medicine & Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53233', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora Health Care', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Kara Hoppe, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}