Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT04076020
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2019-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'magnanij@pitt.edu', 'phone': '(412)383-0611', 'title': 'Dr. Jared Magnani', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Data collection occurred from date of consent through the participants 12-month visit.', 'description': "The study team will learn of adverse events (AE) and serious AEs (SAE) by participant interview at the 4-, 8-, and 12-month assessments; direct contact by participants during the scheduled check-in calls; review of the electronic health record; communication from referring physicians or participants'' providers; or contact with study team initiated by family or other participant surrogates.", 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.\n\nRelational agent/AliveCor Kardia - Intervention: Use of the relational agent and Kardia daily for 120 days.', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 32, 'seriousNumAtRisk': 135, 'deathsNumAffected': 4, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Receive a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.\n\nParticipants are directed to use the WebMD application as often as they would like.\n\nUsual Care: Use of the WebMD app daily for 120 days.', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 40, 'seriousNumAtRisk': 135, 'deathsNumAffected': 6, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chest pain-cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Postoperative hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'INR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rotator cuff injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Facial muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Renal calculi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Peripheral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Unknown classification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'seriousEvents': [{'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gastric hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Retroperitoneal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Salivary duct inflamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Small intestine obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Endocarditis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gallbladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Joint infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Transient ischemic attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Days Covered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received the relational agent and the AliveCor Kardia to use for 120 days.\n\nParticipants were directed to use the relational agent and AliveCor Kardia daily.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.\n\nParticipants were directed to use the WebMD application as often as they would like.'}], 'classes': [{'categories': [{'measurements': [{'value': '.97', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.00'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '1.00'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Results presented from Wilcoxon-Mann-Whitney test with PDC as the dependent variable.', 'groupDescription': 'Proportion of days covered (PDC) at 12 months. A sample size of 119 in each study arm enabled us to detect a minimum difference in PDC of 11.7% with 85% power (assuming a standard deviation=30%). Our power calculations assume use of 2-sided tests with 0.05 significance level.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Proportion of days covered (PDC) analyzed as a binary variable with optimal adherence determined as ≥0.80) variables using logistic regression and adjustment for trial stratification factors. Our power calculations assume use of 2-sided tests with 0.05 significance level.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'Proportion of Days Covered (PDC), obtained from collection of electronic prescription and pharmacy fill data, and defined as the proportion of availability of medication for the period of interest. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication as indicated by pharmacy records.', 'unitOfMeasure': 'Proportion of days covered', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Initial data set included 270 participants. 7 cases of no pharmacy data, 12 cases with start date after end date, and 1 case where one fill was available before randomization. PDC was calculated for 250 participants.'}, {'type': 'PRIMARY', 'title': 'Self-reported Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received the relational agent and the AliveCor Kardia to use for 120 days.\n\nParticipants were directed to use the relational agent and AliveCor Kardia daily.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.\n\nParticipants were directed to use the WebMD application as often as they would like.'}], 'classes': [{'title': 'Adherence-4 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Adherent', 'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}, {'title': 'Non-adherent', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Adherence-8 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Adherent', 'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}, {'title': 'Non-adherent', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Adherence-12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Adherent', 'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}, {'title': 'Non-adherent', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Difference in self-reported adherence reported across baseline, 4-, 8-, and 12-month visits using generalized estimating equations and adjusted for trial stratification factors.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4, 8, and 12 months', 'description': 'Self-reported adherence to oral anticoagulation. 3-item instrument with range 1-5 such that lower scores indicate more frequent medication adherence. Here the score is dichotomized by classifying participants reporting 1 for all three items as adherent and those that reported ≥ 2 on any item as non-adherent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention 4-month: n=117 (11 withdrawals \\[w/d\\], 1 death; 4 discontinued \\[d/c\\] oral anticoagulation \\[OAC\\]; 2 missed visit) 8-month: n=114 (total 12 w/d, 4 deaths; 3 d/c OAC; 2 missed visit) 12-month: n=114 (total 12 w/d, 4 deaths, 5 d/c OAC)\n\nControl 4-month: n=121 (8 w/d, 4 deaths; 1 d/c OAC; 1 missed visit) 8-month: n=118 (total 8 w/d, 6 deaths; 3 d/c OAC) 12-month: n=115 (total 8 w/d, 6 deaths; 4 d/c OAC; 2 missed visit)'}, {'type': 'SECONDARY', 'title': 'Atrial Fibrillation Effect on Quality of Life (AFEQT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received the relational agent and the AliveCor Kardia to use for 120 days.\n\nParticipants were directed to use the relational agent and AliveCor Kardia daily.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.\n\nParticipants were directed to use the WebMD application as often as they would like.'}], 'classes': [{'title': 'Overall Score : 4-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '60.2', 'upperLimit': '88.0'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '63.0', 'upperLimit': '90.7'}]}]}, {'title': 'Overall Score : 8-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.5', 'groupId': 'OG000', 'lowerLimit': '63.9', 'upperLimit': '92.6'}, {'value': '79.6', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '93.5'}]}]}, {'title': 'Overall Score: 12-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000', 'lowerLimit': '63.9', 'upperLimit': '88.9'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '62.0', 'upperLimit': '90.7'}]}]}, {'title': 'Symptoms : 4-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '70.8', 'upperLimit': '95.8'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '100.0'}]}]}, {'title': 'Symptoms : 8-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '100.0'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '79.2', 'upperLimit': '100.0'}]}]}, {'title': 'Symptoms : 12-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '70.8', 'upperLimit': '100.0'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '100.0'}]}]}, {'title': 'Daily Activities : 4-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.8', 'groupId': 'OG000', 'lowerLimit': '41.7', 'upperLimit': '85.4'}, {'value': '68.8', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '89.6'}]}]}, {'title': 'Daily Activities : 8-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '54.2', 'upperLimit': '91.7'}, {'value': '75.00', 'groupId': 'OG001', 'lowerLimit': '54.2', 'upperLimit': '93.8'}]}]}, {'title': 'Daily Activities : 12-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.8', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '87.5'}, {'value': '72.9', 'groupId': 'OG001', 'lowerLimit': '45.8', 'upperLimit': '89.6'}]}]}, {'title': 'Treatment Concern : 4-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '69.4', 'upperLimit': '97.2'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '97.2'}]}]}, {'title': 'Treatment Concern : 8-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '72.2', 'upperLimit': '97.2'}, {'value': '86.1', 'groupId': 'OG001', 'lowerLimit': '69.4', 'upperLimit': '94.2'}]}]}, {'title': 'Treatment Concern : 12-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '69.4', 'upperLimit': '97.2'}, {'value': '86.1', 'groupId': 'OG001', 'lowerLimit': '69.4', 'upperLimit': '94.4'}]}]}, {'title': 'Satisfaction: Relief of Symptoms: 4-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.0', 'groupId': 'OG000', 'lowerLimit': '66.7', 'upperLimit': '100.0'}, {'value': '83.0', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '100.0'}]}]}, {'title': 'Satisfaction: Relief of Symptoms: 8-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '66.7', 'upperLimit': '100.0'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '100.0'}]}]}, {'title': 'Satisfaction: Relief of Symptoms: 12-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '66.7', 'upperLimit': '100.0'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '100.0'}]}]}, {'title': 'Satisfaction: Control of Symptoms: 4-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '66.7', 'upperLimit': '100.0'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '100.0'}]}]}, {'title': 'Satisfaction: Control of Symptoms: 8-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '66.7', 'upperLimit': '100.0'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '100.0'}]}]}, {'title': 'Satisfaction: Control of Symptoms: 12-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '66.7', 'upperLimit': '100.0'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '66.7', 'upperLimit': '100.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4, 8, and 12 months', 'description': 'The AFEQT is a widely used measure of atrial fibrillation-specific health-related quality of life which consists of a global score and 4 domains (symptoms, daily activities, treatment concerns, and treatment satisfaction). Overall or subscale scores range from 0-100 with higher scores indicating superior health-related quality of life in AF. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention arm:\n\n4-month visit, n=121 (11 withdrawals, 1 death; 2 missed this visit) 8-month visit, n=117 (total 12 withdrawals, 4 deaths; 2 missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths, no missed visit)\n\nControl arm:\n\n4-month visit, n=122 (8 withdrawals, 4 deaths; 1 missed this visit) 8-month visit, n=121 (total 6 deaths; no missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths; 2 missed this visit)'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received the relational agent and the AliveCor Kardia to use for 120 days.\n\nParticipants were directed to use the relational agent and AliveCor Kardia daily.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.\n\nParticipants were directed to use the WebMD application as often as they would like.'}], 'classes': [{'title': 'Physical Function: 4 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000', 'lowerLimit': '35.8', 'upperLimit': '47.6'}, {'value': '41.8', 'groupId': 'OG001', 'lowerLimit': '36.9', 'upperLimit': '56.9'}]}]}, {'title': 'Physical Function: 8 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000', 'lowerLimit': '37.6', 'upperLimit': '56.9'}, {'value': '42.1', 'groupId': 'OG001', 'lowerLimit': '37.6', 'upperLimit': '48.1'}]}]}, {'title': 'Physical Function: 12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000', 'lowerLimit': '36.4', 'upperLimit': '48.2'}, {'value': '41.7', 'groupId': 'OG001', 'lowerLimit': '36.4', 'upperLimit': '56.9'}]}]}, {'title': 'Depression and Sadness: 4 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '55.5'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '54.3'}]}]}, {'title': 'Depression and Sadness: 8 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '53.0'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '53.0'}]}]}, {'title': 'Depression and Sadness: 12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '55.5'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '55.5'}]}]}, {'title': 'Pain Interference: 4 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '61.3'}, {'value': '54.85', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '61.3'}]}]}, {'title': 'Pain Interference: 8 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '60.0'}, {'value': '54.4', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '59.9'}]}]}, {'title': 'Pain Interference: 12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '61.3'}, {'value': '53.9', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '59.7'}]}]}, {'title': 'Ability to Participate: 4 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '58.3'}, {'value': '48.3', 'groupId': 'OG001', 'lowerLimit': '44.2', 'upperLimit': '58.5'}]}]}, {'title': 'Ability to Participate: 8 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000', 'lowerLimit': '44.2', 'upperLimit': '58.1'}, {'value': '51.8', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '64.2'}]}]}, {'title': 'Ability to Participate: 12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000', 'lowerLimit': '44.6', 'upperLimit': '58.3'}, {'value': '51.7', 'groupId': 'OG001', 'lowerLimit': '44.2', 'upperLimit': '57.6'}]}]}, {'title': 'Fatigue: 4 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '46.4', 'upperLimit': '59.3'}, {'value': '53.1', 'groupId': 'OG001', 'lowerLimit': '46.1', 'upperLimit': '58.9'}]}]}, {'title': 'Fatigue: 8 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '46.4', 'upperLimit': '57.1'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '57.2'}]}]}, {'title': 'Fatigue: 12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '46.0', 'upperLimit': '57.1'}, {'value': '51.3', 'groupId': 'OG001', 'lowerLimit': '48.6', 'upperLimit': '60.7'}]}]}, {'title': 'Anxiety and Fear: 4 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000', 'lowerLimit': '40.3', 'upperLimit': '57.5'}, {'value': '48.8', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '56.0'}]}]}, {'title': 'Anxiety and Fear: 8 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000', 'lowerLimit': '40.3', 'upperLimit': '55.6'}, {'value': '47.9', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '56.0'}]}]}, {'title': 'Anxiety and Fear: 12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000', 'lowerLimit': '40.3', 'upperLimit': '56.0'}, {'value': '47.9', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '56.0'}]}]}, {'title': 'Sleep Disturbance: 4 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000', 'lowerLimit': '43.8', 'upperLimit': '55.8'}, {'value': '51.1', 'groupId': 'OG001', 'lowerLimit': '44.2', 'upperLimit': '54.5'}]}]}, {'title': 'Sleep Disturbance: 8 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '54.7'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '43.5', 'upperLimit': '55.3'}]}]}, {'title': 'Sleep Disturbance: 12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000', 'lowerLimit': '44.6', 'upperLimit': '55.5'}, {'value': '51.7', 'groupId': 'OG001', 'lowerLimit': '45.1', 'upperLimit': '55.5'}]}]}, {'title': 'Pain Intensity: 4 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Pain Intensity: 8 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Pain Intensity: 12 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4, 8, and 12 months', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses 7 domains (physical function; depression and sadness; pain interference; satisfaction with participation in social roles and activities; fatigue; anxiety and fear; sleep disturbance), 4 questions each, and Pain Intensity with a single item. The 7 domain scores are transformed using a T-score with a mean of 50, standard deviation of 10, in a referent population. Higher scores indicate worse health for the depression, pain, fatigue, anxiety/sleep domains, while higher scores indicate better health for the physical function and satisfaction domains. The single Pain Intensity item is scored 0 (No pain) to 10 (Worst imaginable pain) in the past 7 days.\n\nFurther details on PROMIS scoring are available at https://www.healthmeasures.net/images/PROMIS/manuals/PROMIS\\_Adult\\_Profile\\_Scoring\\_Manual.pdf.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention arm:\n\n4-month visit, n=121 (11 withdrawals, 1 death; 2 missed this visit) 8-month visit, n=117 (total 12 withdrawals, 4 deaths; 2 missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths, no missed visit)\n\nControl arm:\n\n4-month visit, n=122 (8 withdrawals, 4 deaths; 1 missed this visit) 8-month visit, n=121 (total 6 deaths; no missed this visit) 12-month visit, n=119 (no additional withdrawals, no additional deaths; 2 missed this visit)'}, {'type': 'SECONDARY', 'title': 'Emergency Room Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.\n\nRelational agent/AliveCor Kardia - Intervention: Use of the relational agent and Kardia daily for 120 days.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Receive a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.\n\nParticipants are directed to use the WebMD application as often as they would like.\n\nUsual Care: Use of the WebMD app daily for 120 days.'}], 'classes': [{'title': 'Participants with no ER visits', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Participants with 1 or more ER visits', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The number of participants with 1 or more emergency room visits will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.\n\nRelational agent/AliveCor Kardia - Intervention: Use of the relational agent and Kardia daily for 120 days.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Receive a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.\n\nParticipants are directed to use the WebMD application as often as they would like.\n\nUsual Care: Use of the WebMD app daily for 120 days.'}], 'classes': [{'title': 'Participants with no hospital admission', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Participants with 1 or more hospital admissions', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The number of participants with one or more hospitalization will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention: ECA/Kardia', 'description': 'Participants received the relational agent and the AliveCor Kardia to use for 120 days.\n\nParticipants were directed to use the relational agent and AliveCor Kardia daily.\n\nRelational agent/AliveCor Kardia - Intervention Group: Use of the relational agent and Kardia daily for 120 days.'}, {'id': 'FG001', 'title': 'Control: WebMD', 'description': 'Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.\n\nParticipants were directed to use the WebMD application as often as they would like.\n\nUsual Care: Use of the WebMD app daily for 120 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Participants were recruited based on physician referral at numerous University of Pittsburgh Medical Center (UPMC) sites located in rural Pennsylvania counties. The first participant was enrolled on January 8th, 2020 and the last participant was enrolled in March 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm', 'description': 'Participants received the relational agent and the AliveCor Kardia to use for 120 days.\n\nParticipants were directed to use the relational agent and AliveCor Kardia daily.\n\nRelational agent/AliveCor Kardia - Intervention Group: Use of the relational agent and Kardia daily for 120 days.'}, {'id': 'BG001', 'title': 'Usual Care Arm', 'description': 'Participants received a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.\n\nParticipants were directed to use the WebMD application as often as they would like.\n\nUsual Care: Use of the WebMD app daily for 120 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'groupId': 'BG000', 'lowerLimit': '66.8', 'upperLimit': '78.8'}, {'value': '72.7', 'groupId': 'BG001', 'lowerLimit': '67.9', 'upperLimit': '78.5'}, {'value': '73.1', 'groupId': 'BG002', 'lowerLimit': '67.5', 'upperLimit': '78.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anticoagulant medication used for stroke prevention', 'classes': [{'categories': [{'title': 'Warfarin', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Direct acting oral anticoagulant', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participant receipt of oral medication for thromboembolic stroke prevention, classified as either warfarin or direct acting oral anticoagulant.', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'High school, vocational or trade school or less', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Some College or associate degree', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'College (Bachelors or higher)', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment Status', 'classes': [{'categories': [{'title': 'Currently Working, Part-time or Full-time', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Not Currently Working', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Retired', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'categories': [{'title': 'Single, not married', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Married or living as married', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}, {'title': 'Separated or divorced', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Widowed', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cohabitation', 'classes': [{'categories': [{'title': 'Resides with others', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}, {'title': 'Resides alone', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Housing', 'classes': [{'categories': [{'title': 'Renting', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Buying, and Paying mortgage', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Own', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'Neither own nor pay rent', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Prefer not to respond', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Housing ownership status', 'classes': [{'categories': [{'title': 'Ownership', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'Rent or other status', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking', 'classes': [{'categories': [{'title': 'Never Smoke', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Past Smoker', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol consumption, heavy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Dichotomous indication of "Heavy weekly drinking," determined by self-report. Heavy alcohol consumption determined in women, 8 or more drinks/week and in men, 15 or more drinks/week', 'unitOfMeasure': 'Participants'}, {'title': 'History of any cardioversion', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'History of treatment with electrical cardioversion and/or pharmacologic cardioversion. Some participants reported undergoing both electrical and pharmacologic cardioversion.', 'unitOfMeasure': 'Participants'}, {'title': 'Electrical Cardioversion', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'History of cardioversion performed by administration of electrical therapy.', 'unitOfMeasure': 'Participants'}, {'title': 'Pharmacologic cardioversion', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'History of cardioversion performed by administration of pharmacologic therapy', 'unitOfMeasure': 'Participants'}, {'title': 'Health Literacy', 'classes': [{'categories': [{'title': 'Limited Health Literacy', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Adequate Health Literacy', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Newest Vital Sign tool was used to assess health literacy. Scores range from 0 to 6, with limited limited health literacy defined by a score of 0 to 3 and adequate health literacy by a sore of 4 to 6.', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '33.5', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '33.1', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index recorded directly from the electronic health record.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'AF History', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '7.0', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '6.4', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Duration in years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'AF Effect on Quality-of-Life questionnaire (AFEQT)', 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '75.1', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '73.7', 'spread': '17.0', 'groupId': 'BG001'}, {'value': '74.4', 'spread': '16.1', 'groupId': 'BG002'}]}]}, {'title': 'Symptoms', 'categories': [{'measurements': [{'value': '85.5', 'spread': '15.0', 'groupId': 'BG000'}, {'value': '83.5', 'spread': '17.1', 'groupId': 'BG001'}, {'value': '84.5', 'spread': '16.1', 'groupId': 'BG002'}]}]}, {'title': 'Daily activities', 'categories': [{'measurements': [{'value': '66.0', 'spread': '23.6', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '25.0', 'groupId': 'BG001'}, {'value': '66.6', 'spread': '24.2', 'groupId': 'BG002'}]}]}, {'title': 'Treatment concern', 'categories': [{'measurements': [{'value': '80.4', 'spread': '16.6', 'groupId': 'BG000'}, {'value': '76.1', 'spread': '19.1', 'groupId': 'BG001'}, {'value': '78.2', 'spread': '18.0', 'groupId': 'BG002'}]}]}, {'title': 'Treatment Satisfaction: How well treatment controls symptoms', 'categories': [{'measurements': [{'value': '82.6', 'spread': '17.5', 'groupId': 'BG000'}, {'value': '79.0', 'spread': '18.9', 'groupId': 'BG001'}, {'value': '80.8', 'spread': '18.3', 'groupId': 'BG002'}]}]}, {'title': 'Treatment satisfaction: Relief of symptoms', 'categories': [{'measurements': [{'value': '81.0', 'spread': '19.0', 'groupId': 'BG000'}, {'value': '77.7', 'spread': '21.6', 'groupId': 'BG001'}, {'value': '79.3', 'spread': '20.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'AF Effect on Quality-of-Life questionnaire (AFEQT)\n\nOverall score and individual domain scores at baseline.\n\nScoring: Scores for the overall score and each subscale range from 0-100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient-Reported Outcomes Measurement Information System (PROMIS-29)', 'classes': [{'title': 'Physical function', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'BG000', 'lowerLimit': '36.0', 'upperLimit': '47.6'}, {'value': '42.9', 'groupId': 'BG001', 'lowerLimit': '36.6', 'upperLimit': '48.2'}, {'value': '41.8', 'groupId': 'BG002', 'lowerLimit': '36.4', 'upperLimit': '48.2'}]}]}, {'title': 'Depression and sadness', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'BG000', 'lowerLimit': '41.0', 'upperLimit': '52.1'}, {'value': '48.9', 'groupId': 'BG001', 'lowerLimit': '41.0', 'upperLimit': '55.4'}, {'value': '48.9', 'groupId': 'BG002', 'lowerLimit': '41.0', 'upperLimit': '54.1'}]}]}, {'title': 'Pain interference', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'BG000', 'lowerLimit': '41.6', 'upperLimit': '60.0'}, {'value': '55.7', 'groupId': 'BG001', 'lowerLimit': '41.6', 'upperLimit': '61.3'}, {'value': '54.8', 'groupId': 'BG002', 'lowerLimit': '41.6', 'upperLimit': '61.3'}]}]}, {'title': 'Satisfaction with participation in social roles and activities', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'BG000', 'lowerLimit': '41.6', 'upperLimit': '60.0'}, {'value': '55.7', 'groupId': 'BG001', 'lowerLimit': '41.6', 'upperLimit': '61.3'}, {'value': '54.8', 'groupId': 'BG002', 'lowerLimit': '41.6', 'upperLimit': '61.3'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'BG000', 'lowerLimit': '46.0', 'upperLimit': '55.2'}, {'value': '51.9', 'groupId': 'BG001', 'lowerLimit': '48.6', 'upperLimit': '60.7'}, {'value': '51.0', 'groupId': 'BG002', 'lowerLimit': '46.0', 'upperLimit': '58.7'}]}]}, {'title': 'Anxiety and fear', 'categories': [{'measurements': [{'value': '48.2', 'groupId': 'BG000', 'lowerLimit': '40.3', 'upperLimit': '55.2'}, {'value': '51.4', 'groupId': 'BG001', 'lowerLimit': '40.3', 'upperLimit': '57.5'}, {'value': '50.4', 'groupId': 'BG002', 'lowerLimit': '40.3', 'upperLimit': '56.0'}]}]}, {'title': 'Sleep disturbance', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'BG000', 'lowerLimit': '44.3', 'upperLimit': '55.8'}, {'value': '50.8', 'groupId': 'BG001', 'lowerLimit': '44.2', 'upperLimit': '55.8'}, {'value': '51.0', 'groupId': 'BG002', 'lowerLimit': '44.2', 'upperLimit': '55.8'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS-29) assesses 7 domains with 4 questions each with scores transformed using a T-score such that scores have a mean of 50 and standard deviation of 10 in a referent population. Domains are: physical function; depression and sadness; pain interference; satisfaction with participation in social roles and activities; fatigue; anxiety and fear; and sleep disturbance. Higher scores indicate worse or more severe depression, pain, fatigue, anxiety/sleep domains, while better health for the physical function and satisfaction domains.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Self-reported adherence', 'classes': [{'categories': [{'title': 'Adherent', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}, {'title': 'Non-adherent', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported daily adherence to oral anticoagulation dichotomized as adherent or non-adherent. Three-item instrument each scaled 1-5. Individuals reporting 1 for all items classified as adherent; any individual reporting 2 or higher on any item classified as non-adherent.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-30', 'size': 834967, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-26T14:12', 'hasProtocol': True}, {'date': '2023-04-30', 'size': 181262, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-26T14:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2019-08-28', 'resultsFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2019-08-29', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-29', 'studyFirstPostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Days Covered', 'timeFrame': '12 months', 'description': 'Proportion of Days Covered (PDC), obtained from collection of electronic prescription and pharmacy fill data, and defined as the proportion of availability of medication for the period of interest. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication as indicated by pharmacy records.'}, {'measure': 'Self-reported Adherence', 'timeFrame': '4, 8, and 12 months', 'description': 'Self-reported adherence to oral anticoagulation. 3-item instrument with range 1-5 such that lower scores indicate more frequent medication adherence. Here the score is dichotomized by classifying participants reporting 1 for all three items as adherent and those that reported ≥ 2 on any item as non-adherent.'}], 'secondaryOutcomes': [{'measure': 'Atrial Fibrillation Effect on Quality of Life (AFEQT)', 'timeFrame': '4, 8, and 12 months', 'description': 'The AFEQT is a widely used measure of atrial fibrillation-specific health-related quality of life which consists of a global score and 4 domains (symptoms, daily activities, treatment concerns, and treatment satisfaction). Overall or subscale scores range from 0-100 with higher scores indicating superior health-related quality of life in AF. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).'}, {'measure': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29', 'timeFrame': '4, 8, and 12 months', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses 7 domains (physical function; depression and sadness; pain interference; satisfaction with participation in social roles and activities; fatigue; anxiety and fear; sleep disturbance), 4 questions each, and Pain Intensity with a single item. The 7 domain scores are transformed using a T-score with a mean of 50, standard deviation of 10, in a referent population. Higher scores indicate worse health for the depression, pain, fatigue, anxiety/sleep domains, while higher scores indicate better health for the physical function and satisfaction domains. The single Pain Intensity item is scored 0 (No pain) to 10 (Worst imaginable pain) in the past 7 days.\n\nFurther details on PROMIS scoring are available at https://www.healthmeasures.net/images/PROMIS/manuals/PROMIS\\_Adult\\_Profile\\_Scoring\\_Manual.pdf.'}, {'measure': 'Emergency Room Visits', 'timeFrame': '12 months', 'description': 'The number of participants with 1 or more emergency room visits will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.'}, {'measure': 'Hospital Admissions', 'timeFrame': '12 months', 'description': 'The number of participants with one or more hospitalization will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adherence', 'Health Literacy', 'quality of life'], 'conditions': ['Atrial Fibrillation', 'Familial Atrial Fibrillation', 'Arrhythmia, Cardiac', 'Heart Diseases', 'Pathologic Processes']}, 'referencesModule': {'references': [{'pmid': '37889198', 'type': 'DERIVED', 'citation': 'Mann HK, Streiff M, Schultz KC, Halpern DV, Ferry D, Johnson AE, Magnani JW. Rurality and Atrial Fibrillation: Patient Perceptions of Barriers and Facilitators to Care. J Am Heart Assoc. 2023 Nov 7;12(21):e031152. doi: 10.1161/JAHA.123.031152. Epub 2023 Oct 27.'}, {'pmid': '33769555', 'type': 'DERIVED', 'citation': 'Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is a highly prevalent, morbid condition. Anticoagulation to prevent thromboembolic strokes is a foremost priority in AF but adherence is challenging for patients and lapses in anticoagulation are common. Chronic disease self-management (CDSM) is a recognized program to enhance self-efficacy and improve adherence, quality of life, and patient-centered health outcomes. Rural patients with AF experience increased vulnerability to adverse outcomes due to geographic and social isolation, poor health care access, and limited health literacy. This study uses an innovative, scalable CDSM intervention to improve anticoagulation adherence in rural patients with AF.', 'detailedDescription': 'This is a randomized clinical trial to evaluate the effect of an embodied conversational agent (ECA) on health outcomes in people with atrial fibrillation. The study will enroll 264 patients who reside in rural, Western Pennsylvania who have atrial fibrillation. Participants will be randomized to the intervention or usual care. Intervention participants will receive a contemporary mobile phone, commonly known and referred to herein as a smartphone, with a relational agent, which simulates conversation and provides coaching, guidance, and assistance with chronic disease self-management. In addition participants will receive an FDA-approved instrument for heart rate and rhythm monitoring, which is named the "AliveCor KardiaMobile" device (herein referred to as the AliveCor Kardia), that pairs with the relational agent. Usual care participants will receive a smartphone as well, which will have the general health application called "WebMD." The intervention will last 4 months and participants will have visits at baseline, 4, 8 and 12 months. The study will evaluate the improvement in adherence to anticoagulation, quality of life, and health care utilization resulting from the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult, age ≥21;\n2. Diagnosis of AF, identified from the electronic health record (EHR) problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (CG, Holter or event monitor);\n3. Prescribed use of warfarin or direct-acting oral anticoagulant (DOAC) for AF stroke prevention;\n4. English-speaking well enough to participate in informed consent and this study;\n5. No plans to relocate from the area within 12 months of enrollment.\n\nExclusion Criteria:\n\n1. Conditions other than AF that require anticoagulation, such as mechanical prosthetic valve, deep vein thrombosis, or pulmonary embolism;\n2. History of pulmonary vein isolation or foreseen pulmonary vein isolation;\n3. History of atrioventricular (AV) nodal ablation or foreseen AV nodal ablation;\n4. Heart failure necessitating hospital admission ≤3 months prior to study inclusion;\n5. Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion;\n6. Untreated hyperthyroidism or ≤3 months euthyroidism before inclusion;\n7. Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy;\n8. Cardiac surgery ≤3 months before inclusion;\n9. Planned cardiac surgery;\n10. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);\n11. Inability to comprehend the study protocol, defined as failing to answer correctly a set of questions on orientation and short-term memory during the consent process.'}, 'identificationModule': {'nctId': 'NCT04076020', 'acronym': 'AFibLITT_R', 'briefTitle': 'Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Mobile Health Intervention for Rural Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'STUDY19050386'}, 'secondaryIdInfos': [{'id': 'R01HL143010', 'link': 'https://reporter.nih.gov/quickSearch/R01HL143010', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.', 'interventionNames': ['Behavioral: Relational agent/AliveCor Kardia - Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Receive a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application.\n\nParticipants are directed to use the WebMD application as often as they would like.', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Relational agent/AliveCor Kardia - Intervention', 'type': 'BEHAVIORAL', 'description': 'Use of the relational agent and Kardia daily for 120 days.', 'armGroupLabels': ['Intervention']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Use of the WebMD app daily for 120 days.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Jared W. Magnani, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Such data will be available beginning 9 months and ending 36 months following publication of the main manuscripts resulting from this clinical trial.', 'ipdSharing': 'YES', 'description': "The study team will share individual participant data that underlie the results reported in the study's central manuscripts after deidentification (text, tables, figures, and appendices).", 'accessCriteria': 'Data will be made available to those investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals may be submitted up to 36 months following article publication. Applicants requesting access to the data will be responsible for the minimal administrative costs to provide the data set.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Northeastern University', 'class': 'OTHER'}, {'name': 'Boston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jared W Magnani, MD, MSc', 'investigatorAffiliation': 'University of Pittsburgh'}}}}