Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 3:18 PM
Study NCT ID:
NCT01972308
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2013-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andrea.apter@uphs.upenn.edu', 'phone': '215 349-5120', 'title': 'Andrea J Apter, MD', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'one year', 'eventGroups': [{'id': 'EG000', 'title': 'Patient Advocate', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.\n\nPatient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients", 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 71, 'seriousNumAtRisk': 156, 'deathsNumAffected': 4, 'seriousNumAffected': 89}, {'id': 'EG001', 'title': 'Usual Care', 'description': "Patient receives asthma care as usual from their asthma provider\n\nPatient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients", 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 74, 'seriousNumAtRisk': 156, 'deathsNumAffected': 1, 'seriousNumAffected': 90}], 'otherEvents': [{'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'short of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'foot pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'skin disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'flu-like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'arthralgia shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'neoplasm benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'respiratory, thoracic, and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'GERD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'hemorroids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'pregnancy, puerperium and perinatal conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'sinus pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'bladder tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'ear and labyrinth disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'corneal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'esophageal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'autoimmune disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'noncardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'cystitis noninfective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'papularpustulo rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'muscle weakness upper limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}], 'seriousEvents': [{'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 44}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'foot pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'short of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'surgical and medical procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 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'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'kidney stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'sleep apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'small intestine obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'stroke symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'uterine pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'deep venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'ventricular arrhrythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'ear and labyrinth disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'corneal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'infection and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'peritoneal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'sinus disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}, {'term': 'foot weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SAFETY PROFILER'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Asthma Control at One Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Advocate', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patient receives asthma care as usual from their asthma provider'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'groupId': 'OG000', 'lowerLimit': '-0.65', 'upperLimit': '-0.18'}, {'value': '-0.11', 'groupId': 'OG001', 'lowerLimit': '-0.37', 'upperLimit': '0.12'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group differences in expected 12 month c', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.04', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 1 year', 'description': "Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion.\n\nAsthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score \\> 1.5 is considered inadequate control.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "18 years or more, physician's diagnosis of asthma, prescribed an inhaled-steroid for asthma, moderate or severe persistent asthma, evidence of reversible airflow obstruction, at least one appointment scheduled with the asthma physician during the 1st 6 months of participation"}, {'type': 'SECONDARY', 'title': 'Change in Emergency Department(ED) Visits at One Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Advocate', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.\n\nPatient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patient receives asthma care as usual from their asthma provider'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.90', 'groupId': 'OG000', 'lowerLimit': '-1.50', 'upperLimit': '-0.42'}, {'value': '-0.24', 'groupId': 'OG001', 'lowerLimit': '-0.60', 'upperLimit': '0.18'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group differences in expected 12 month c', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '-0.01', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'one year', 'description': 'Emergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint', 'unitOfMeasure': 'visits per 6 months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Asthma-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Advocate', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patient receives asthma care as usual from their asthma provider'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.54'}, {'value': '0.23', 'groupId': 'OG001', 'lowerLimit': '-0.05', 'upperLimit': '0.48'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group differences in expected 12 month c', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.43', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline to one year', 'description': 'Asthma-related quality of life will be measured with the Mini-Asthma Quality of Life Questionnaire (AQLQ). This 15-item questionnaire with each item having a 7-point response scale that provides a mean summary score. A 0.5-unit change is considered clinically meaningful. the range is 1 - 7 with higher score better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Advocate', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.\n\nPatient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Patient receives asthma care as usual from their asthma provider\n\nPatient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG000', 'lowerLimit': '-0.66', 'upperLimit': '-0.06'}, {'value': '-0.36', 'groupId': 'OG001', 'lowerLimit': '-0.66', 'upperLimit': '-0.12'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group differences in expected 12 month c', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.48', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'one year', 'description': 'Participants will report hospitalizations verified if possible in participating health systems. We review records and if not available ask patient for hospititalizations over the 6 months before baseline and compare it with the record or report in the 6-months prior to one year.', 'unitOfMeasure': 'hospitalizations per 6 months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Risk of Prednisone Bursts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Advocate', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.\n\nPatient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patient receives asthma care as usual from their asthma provider'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.005', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.10'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.14', 'upperLimit': '0.05'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group differences in expected 12 month c', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.19', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and one year', 'description': 'a new dose or an increase in already prescribed prednisone dose', 'unitOfMeasure': 'risk of prednisone bursts', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Urgent Office Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patient Advocate', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.\n\nPatient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patient receives asthma care as usual from their asthma provider'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.24', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '0.02'}, {'value': '-0.42', 'groupId': 'OG001', 'lowerLimit': '-0.72', 'upperLimit': '-0.12'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group differences in expected 12 month c', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.60', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'one year', 'description': 'Records or if not available patient report of an urgent office visit in the 6 months before baseline compared with record or report of urgent office visits in the 6 months prior to one year. An urgent office visit is one scheduled within 24 hours of the visit.', 'unitOfMeasure': 'urgent visits per 6 months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patient Advocate', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.\n\nPatient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Patient receives asthma care as usual from their asthma provider'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '148'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patient Advocate', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.\n\nPatient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients"}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Patient receives asthma care as usual from their asthma provider'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '49.6', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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': '100', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'asthma control questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '2.4', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score \\> 1.5 is considered inadequate control.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-07-03', 'size': 423455, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-31T10:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2013-10-16', 'resultsFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2013-10-29', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-03', 'studyFirstPostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Asthma Control at One Year', 'timeFrame': 'baseline and 1 year', 'description': "Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion.\n\nAsthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score \\> 1.5 is considered inadequate control."}], 'secondaryOutcomes': [{'measure': 'Change in Emergency Department(ED) Visits at One Year', 'timeFrame': 'one year', 'description': 'Emergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint'}, {'measure': 'Change in Asthma-related Quality of Life', 'timeFrame': 'baseline to one year', 'description': 'Asthma-related quality of life will be measured with the Mini-Asthma Quality of Life Questionnaire (AQLQ). This 15-item questionnaire with each item having a 7-point response scale that provides a mean summary score. A 0.5-unit change is considered clinically meaningful. the range is 1 - 7 with higher score better quality of life.'}, {'measure': 'Change in Hospitalizations', 'timeFrame': 'one year', 'description': 'Participants will report hospitalizations verified if possible in participating health systems. We review records and if not available ask patient for hospititalizations over the 6 months before baseline and compare it with the record or report in the 6-months prior to one year.'}, {'measure': 'Risk of Prednisone Bursts', 'timeFrame': 'baseline and one year', 'description': 'a new dose or an increase in already prescribed prednisone dose'}, {'measure': 'Change in Urgent Office Visit', 'timeFrame': 'one year', 'description': 'Records or if not available patient report of an urgent office visit in the 6 months before baseline compared with record or report of urgent office visits in the 6 months prior to one year. An urgent office visit is one scheduled within 24 hours of the visit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['asthma', 'patient advocate', 'health disparity', 'patient-provider communication'], 'conditions': ['Asthma', 'Communication']}, 'referencesModule': {'references': [{'pmid': '23800333', 'type': 'BACKGROUND', 'citation': 'Apter AJ, Wan F, Reisine S, Bogen DK, Rand C, Bender B, Bennett IM, Gonzalez R, Priolo C, Sonnad SS, Bryant-Stephens T, Ferguson M, Boyd RC, Ten Have T, Roy J. Feasibility, acceptability and preliminary effectiveness of patient advocates for improving asthma outcomes in adults. J Asthma. 2013 Oct;50(8):850-60. doi: 10.3109/02770903.2013.812655. Epub 2013 Jul 17.'}, {'pmid': '23591273', 'type': 'BACKGROUND', 'citation': 'Apter AJ, Wan F, Reisine S, Bender B, Rand C, Bogen DK, Bennett IM, Bryant-Stephens T, Roy J, Gonzalez R, Priolo C, Have TT, Morales KH. The association of health literacy with adherence and outcomes in moderate-severe asthma. J Allergy Clin Immunol. 2013 Aug;132(2):321-7. doi: 10.1016/j.jaci.2013.02.014. Epub 2013 Apr 13.'}, {'pmid': '26264737', 'type': 'BACKGROUND', 'citation': 'Apter AJ, Bryant-Stephens T, Morales KH, Wan F, Hardy S, Reed-Wells S, Dominguez M, Gonzalez R, Mak N, Nardi A, Park H, Howell JT, Localio R. Using IT to improve access, communication, and asthma in African American and Hispanic/Latino Adults: Rationale, design, and methods of a randomized controlled trial. Contemp Clin Trials. 2015 Sep;44:119-128. doi: 10.1016/j.cct.2015.08.001. Epub 2015 Aug 8.'}, {'pmid': '27777181', 'type': 'BACKGROUND', 'citation': 'Bryant-Stephens T, Reed-Wells S, Canales M, Perez L, Rogers M, Localio AR, Apter AJ. Home visits are needed to address asthma health disparities in adults. J Allergy Clin Immunol. 2016 Dec;138(6):1526-1530. doi: 10.1016/j.jaci.2016.10.006. Epub 2016 Oct 21.'}, {'pmid': '27789250', 'type': 'BACKGROUND', 'citation': 'Kramer CB, LeRoy L, Donahue S, Apter AJ, Bryant-Stephens T, Elder JP, Hamilton WJ, Krishnan JA, Shelef DQ, Stout JW, Sumino K, Teach SJ, Federman AD. Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies. J Allergy Clin Immunol. 2016 Dec;138(6):1600-1607. doi: 10.1016/j.jaci.2016.10.011. Epub 2016 Oct 24.'}, {'pmid': '32673877', 'type': 'BACKGROUND', 'citation': 'Apter AJ, Perez L, Han X, Ndicu G, Localio A, Park H, Mullen AN, Klusaritz H, Rogers M, Cidav Z, Bryant-Stephens T, Bender BG, Reisine ST, Morales KH. Patient Advocates for Low-Income Adults with Moderate to Severe Asthma: A Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2020 Nov-Dec;8(10):3466-3473.e11. doi: 10.1016/j.jaip.2020.06.058. Epub 2020 Jul 14.'}, {'pmid': '28499772', 'type': 'BACKGROUND', 'citation': 'Korwin A, Black H, Perez L, Morales KH, Klusaritz H, Han X, Huang J, Rogers M, Ndicu G, Apter AJ. Exploring Patient Engagement: A Qualitative Analysis of Low-Income Urban Participants in Asthma Research. J Allergy Clin Immunol Pract. 2017 Nov-Dec;5(6):1625-1631.e2. doi: 10.1016/j.jaip.2017.03.022. Epub 2017 May 10.'}, {'pmid': '34785390', 'type': 'DERIVED', 'citation': 'Buckey TM, Morales KH, Apter AJ. Understanding Autonomy in Patients with Moderate to Severe Asthma. J Allergy Clin Immunol Pract. 2022 Feb;10(2):525-533. doi: 10.1016/j.jaip.2021.10.068. Epub 2021 Nov 14.'}]}, 'descriptionModule': {'briefSummary': "Few interventions to improve asthma management have targeted low-income minority asthmatic adults and even fewer have focused on the real-world practice where care is provided for these patients. This project tests the effectiveness of a Patient Advocate as a practical and sustainable method of facilitating and maintaining communication between patient and provider and access to chronic care for adults with moderate or severe asthma recruited from clinics serving low-income urban neighborhoods. We compare the use of a Patient Advocate to current asthma care and test the Patient Advocate's cost-effectiveness.", 'detailedDescription': "This 5 year project tests the effectiveness, sustainability, and budget impact of a patient navigator intervention to facilitate and maintain patient-provider communication and access to chronic care of moderate or severe asthma in low income minority adults with other chronic morbidities. We will recruit from a variety of clinic practices including those of an urban academic health center, a VA, and a federally qualified health center and in both English-speaking and Spanish-speaking patients. The intervention is tailored to patients and their clinics, and informed by focus groups of patients and providers.\n\nThe Patient Advocate (PA), works with patients by coaching and modeling preparation for a visit with the asthma doctor, attending the visit with the permission of participant and provider, and confirming understanding of issues discussed. The PA also facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and exchange of information between providers and patients. The PAs are recent college graduates interested in health-related or education careers, research experience, working with patients, and generally have the same race/ethnicity distribution as potential subjects.\n\nThis dissemination and implementation project refines the intervention of RC1 HL099612 for real-world practice by 1) conducting a randomized controlled trial that compares the Patient Advocate Intervention (PAI) to currently practiced guideline-based usual care; 2) carrying out the intervention in a variety of primary care and asthma specialty practices; 3) extending the observation time to a year to test its sustainability; 4) assessing patient-centered outcomes including asthma control, quality of life, ED visits, and hospitalizations; 5) assessing mediators/moderators of the PAI-asthma outcome relationship; and 6) evaluating its cost-effectiveness.\n\nWe will recruit 300 adults, each to be followed for at least 1 year with moderate or severe persistent asthma from clinics serving low-income, urban, primarily minority patients and conduct a randomized controlled trial (RCT) to: 1) assess whether 6 months of the PAI improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion, 2) Assess whether the PAI improves other asthma outcomes (need for prednisone bursts, ED visits, hospitalizations, quality of life, FEV1) relative to baseline compared with UC at 6 months and is sustained in the 6 months following the intervention's completion, 3) examine mediators and moderators of the relationship between the intervention and outcome, 4) assess the incremental direct and indirect costs of the PAI compared to usual care and the cost-effectiveness of the PAI relative to UC for the outcomes, and 5) in post-study focus groups of providers to explore awareness of the intervention and response to the PA"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. \\> 18 years of age,\n2. physician's diagnosis of asthma,\n3. prescribed an inhaled-steroid-containing medication for asthma (ensuring the patient is believed to have moderate or severe reversible airways obstruction by their physician),\n4. moderate or severe persistent asthma according to the NHLBI Guidelines,\n5. evidence of reversible airflow obstruction: (a) forced expiratory volume in 1 second (FEV1) \\< 80% predicted at the time of screening or within the 3 years prior to this screening, and (b) improvement with bronchodilator: either (i) an increase of \\>15% and 200ml in FEV1 with asthma treatment over the previous 3 years or (ii) after 4 puffs of albuterol by MDI (or 2.5 mg by nebulizer), an increase in FEV1 or FVC \\>12% and 200 ml in FEV1 within 30 minutes,\n6. at least one appointment scheduled with the asthma physician during the 1st 6 months of participation\n\nExclusion Criteria:\n\n1. Severe psychiatric or cognitive problems (e.g., obvious mania, schizophrenia, significant mental retardation) that make it impossible to understand and carryout PA activities.\n2. Unable to understand and provide informed consent,\n3. Unable to communicate in English or Spanish.\n4. Participants of the pilot study for this project are excluded"}, 'identificationModule': {'nctId': 'NCT01972308', 'acronym': 'HAP2', 'briefTitle': 'A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults', 'orgStudyIdInfo': {'id': '1R18HL116285-01', 'link': 'https://reporter.nih.gov/quickSearch/1R18HL116285-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient advocate', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.", 'interventionNames': ['Behavioral: Patient Advocate']}, {'type': 'OTHER', 'label': 'usual care', 'description': 'Patient receives asthma care as usual from their asthma provider', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Patient Advocate', 'type': 'BEHAVIORAL', 'description': "Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to accomplishing medical advice, and transfer of information between provider and patient.", 'armGroupLabels': ['Patient advocate']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Subjects receive asthma care from their proivders in the participating practices which generally follow asthma guidelines', 'armGroupLabels': ['usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Andrea J Apter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andrea Apter', 'investigatorAffiliation': 'University of Pennsylvania'}}}}