Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-29 @ 3:45 PM
Study NCT ID:
NCT05238103
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2022-02-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of a Corrie Cardiac Rehabilitation Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D054059', 'term': 'Coronary Occlusion'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lmathew6@jhmi.edu', 'phone': '410-502-0469', 'title': 'Lena Mathews, MD MHS', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From enrollment until end of follow-up at 12 weeks after randomization', 'description': 'Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)', 'eventGroups': [{'id': 'EG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 4, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 2, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Symptoms during 6 minute walk test', 'notes': 'Patient reporting significant symptoms during 6 minute walk test requiring early termination or modification of 6MWT protocol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain at home (non-cardiac)', 'notes': 'Chest pain at home, deemed non-cardiac etiology and not requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain from wearable device', 'notes': 'Significant pain from wearable device, precluding meaning use of technology and hybrid CR intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed blood sample processing', 'notes': 'Delayed blood sample processing for lab sample collected during final study visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute decompensated heart failure', 'notes': 'Acute decompensated heart failure requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation with rapid ventricular response', 'notes': 'Atrial fibrillation with rapid ventricular response requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ST-elevation myocardial infarction (STEMI) due to bypass graft occlusion', 'notes': 'ST-elevation myocardial infarction (STEMI) due to bypass graft occlusion requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stress cardiomyopathy', 'notes': 'Stress cardiomyopathy requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'notes': 'Syncope event requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain (non-cardiac)', 'notes': 'Non-cardiac chest pain requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorder', 'notes': 'Gastrointestinal disorder requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'notes': 'Infection requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Composite Cardiovascular Health Metric for Secondary Prevention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': "The cardiovascular health metric for secondary prevention (adapted from American Heart Association's Life Simple 7). The score ranges from 0 to 14 with higher score indicating better cardiovascular health.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '122.7', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '121.0', 'spread': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '70.5', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '68.6', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For systolic blood pressure', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For diastolic blood pressure', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': 'Systolic blood pressure and Diastolic blood pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Low Density Lipoprotein - Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '71.4', 'spread': '31.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': 'LDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glycosylated Hemoglobin (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': 'Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (kg/m^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '28.7', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': 'BMI = weight (kg) / height in meters squared (m\\^2). Weight and height measured by study staff at study visit.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'title': 'Global physical health score', 'categories': [{'measurements': [{'value': '50.4', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '52.0', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Global mental health score', 'categories': [{'measurements': [{'value': '52.0', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '52.1', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For: Global physical health score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.71', 'groupIds': ['OG000'], 'groupDescription': 'For: Global mental health score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10: The 10-item patient-reported questionnaire administered at 12 weeks follow up in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'title': 'Ideal', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'title': 'Intermediate', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Poor', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after randomization', 'description': 'Blood pressure control (Cardiovascular secondary health metric component). Ideal (SBP \\<130 mmHg and DBP \\<90 mmHg). Intermediate (SBP 130-139 mmHg or DBP 80-89 mmHg). Poor (SBP ≥140 mmHg or DBP ≥90 mmHg).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cholesterol (LDL-C) Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'title': 'Ideal', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'Intermediate', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'Poor', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after randomization', 'description': 'Cholesterol (LDL-C) control (Cardiovascular secondary health metric component). Ideal (LDL-C \\<70mg/dL). Intermediate (LDL-C 70-99 mg/dL). Poor (LDL-C ≥100mg/dL)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diabetes Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'title': 'Ideal', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Intermediate', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Poor', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after randomization', 'description': 'Diabetes (HbA1c) control (Cardiovascular secondary health metric component). Ideal (HbA1c \\<7% for diabetic, \\<5.7% for non-diabetic). Intermediate (HbA1c 7.0-7.9% for diabetic, 5.0-5.9% for non-diabetic). Poor (HbA1c ≥8% for diabetic, ≥6.5% for non-diabetic).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight (BMI) Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'title': 'Ideal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Intermediate', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'Poor', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after randomization', 'description': 'Weight (BMI) categories (Cardiovascular secondary health metric component). Ideal (BMI \\<25 kg/m\\^2). Intermediate (BMI 25-29 kg/m\\^2). Poor (BMI ≥ 30 kg/m\\^2).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physical Activity Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'title': 'Ideal', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'title': 'Intermediate', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after randomization', 'description': 'Physical activity categories (Cardiovascular secondary health metric component). Ideal (≥150 min/wk moderate physical activity, ≥75 min/wk vigorous physical activity). Intermediate (1-149 min/wk moderate physical activity, 1-74 min/wk vigorous physical activity). Poor (No regular exercise).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diet Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'title': 'Ideal', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'title': 'Intermediate', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after randomization', 'description': 'Diet categories (Cardiovascular secondary health metric component). Ideal (Rate Your Plate score 64-81). Intermediate (Rate Your Plate score 46-63). Poor (Rate Your Plate score 27-45).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tobacco Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'title': 'Ideal/Intermediate (Never/Former smoker)', 'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}, {'title': 'Poor (Recent/Current smoker)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after randomization', 'description': 'Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiac Rehabilitation Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'title': 'Initiation (0-12 sessions attended)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Engagement 1 (13-24 sessions attended)', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Engagement 2 (25-36 sessions attended)', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after randomization', 'description': 'Cardiac rehabilitation engagement as measured by number of participants who attended the sessions per category. Grouped by Healthcare Effectiveness Data and Information Set (HEDIS) categories: Initiation (0-12 sessions attended), Engagement 1 (13-24 sessions attended), Engagement 2 (25-36 sessions attended).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Depression as Assessed by the Patient Health Questionnaire 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks after randomization', 'description': 'The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8): The 8 item questionnaire administered at 12 weeks with the following scoring system: Score range 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.\n\nNote, as an exploratory outcome, only a subgroup of participants responded to this survey request.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anxiety as Assessed by the Generalized Anxiety Disorder 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks after randomization', 'description': 'The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7): The 7-item questionnaire administered at 12 weeks follow up with the following scoring system. Each item is assigned scores of 0, 1, 2, and 3 to the response categories. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stress as Assessed by the Perceived Stress Scale-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': 'The difference in stress level as measured by Perceived Stress Scale (PSS -10): The 10 item questionnaire administered at 12 weeks follow up. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '32.3', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': 'The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS): The 8 item scale administered at 12 weeks follow up. Total scores of the eHEALS range from 8 to 40, with higher scores representing higher self-perceived (e) Health literacy.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Activation as Assessed by the Patient Activation Measure 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.7', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '35.1', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': 'The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10): The 10-item five-point Likert scale for assessing patient activation at 12 weeks follow up, indicating whether the patient possesses the necessary knowledge, skills, and confidence needed for self-care. The total score reference range is from 0 to 100, where higher scores indicate greater patient activation and ability for self-care.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request.'}, {'type': 'PRIMARY', 'title': '6-minute Walking Distance (Meters)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'OG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'classes': [{'categories': [{'measurements': [{'value': '506.1', 'spread': '113.9', 'groupId': 'OG000'}, {'value': '489.8', 'spread': '104.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '16.3', 'ciLowerLimit': '-9.1', 'groupDescription': 'Significance testing: Generalized regression model', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin of 12.5 meters was chosen to represent about 40% of the minimum important difference of 30 meters in the 6 minute walk test as identified in previous studies. For sample size calculation, to allow for an attrition rate of 20% during follow up after randomization, a total of 200 (100 per group) participants were needed to be recruited and then randomized in a 1:1 ration to Intervention vs. Control groups.'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': 'Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'User Engagement as Assessed by the Number of App Interactions (Intervention Group Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}], 'classes': [{'title': 'App interaction for heart rate event', 'categories': [{'measurements': [{'value': '11821.6', 'spread': '17364.7', 'groupId': 'OG000'}]}]}, {'title': 'App interaction for blood pressure event', 'categories': [{'measurements': [{'value': '16.9', 'spread': '19.0', 'groupId': 'OG000'}]}]}, {'title': 'App interaction for exercise completion event', 'categories': [{'measurements': [{'value': '34.9', 'spread': '38.7', 'groupId': 'OG000'}]}]}, {'title': 'App interaction for medication taken event', 'categories': [{'measurements': [{'value': '296.5', 'spread': '264.7', 'groupId': 'OG000'}]}]}, {'title': 'App interaction for weight check event', 'categories': [{'measurements': [{'value': '51.7', 'spread': '35.9', 'groupId': 'OG000'}]}]}, {'title': 'App interaction for mood check event', 'categories': [{'measurements': [{'value': '53.7', 'spread': '35.6', 'groupId': 'OG000'}]}]}, {'title': 'App interaction for step count check event', 'categories': [{'measurements': [{'value': '125.7', 'spread': '168.9', 'groupId': 'OG000'}]}]}, {'title': 'App interaction for education event', 'categories': [{'measurements': [{'value': '17.7', 'spread': '8.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after randomization', 'description': 'Number of interactions in the smartphone app per participant, collected via the Corrie Health Platform User Analytics at 12 weeks follow up (only assessed in intervention arm).', 'unitOfMeasure': 'app interactions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'FG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}], 'recruitmentDetails': 'Assessed for eligibility: 6,170; Met eligibility criteria: 1,252; Met exclusion criteria: 4,918; Excluded: 993 (Declined to participate: 710, Unable to be contacted: 283).', 'preAssignmentDetails': 'Drop-out (pre-randomization/run-in) - 57. (Lost to follow up - 32. Developed exclusion criteria -10. Withdrew consent - 8. Financial reason - 5. Unable to undergo safety evaluation - 2). 259 Enrolled. 202 participants randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.'}, {'id': 'BG001', 'title': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 'African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Declined to answer', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiac Rehabilitation Indication (Disease Category + Treatment Modality)', 'classes': [{'categories': [{'title': 'AMI (Medically treated)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'AMI (Treated with PCI)', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'AMI (Treated with CABG)', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'CAD without AMI (Treated with PCI)', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'CAD without AMI (Treated with CABG)', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'VHD (Treated with TAVR)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'VHD (Treated with Heart valve surgery)', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Combined CABG + Heart valve surgery', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'AMI: Acute myocardial infarction, CAD: Coronary artery disease, CABG: Coronary artery bypass grafting surgery, PCI: Percutaneous coronary intervention, TAVR: Transcatheter aortic valve replacement, VHD: Valvular heart disease', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical History', 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}, {'title': 'Hyperlipidemia', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Tobacco use', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Coronary artery disease', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Valvular heart disease', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'Heart failure', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants may fit into more than one category', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Cardiac Rehabilitation Indication (Disease Category)', 'classes': [{'categories': [{'title': 'AMI', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'CAD without AMI', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'VHD', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'CAD with VHD', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'AMI: Acute myocardial infarction, CAD: Coronary artery disease, CABG: Coronary artery bypass grafting surgery, PCI: Percutaneous coronary intervention, TAVR: Transcatheter aortic valve replacement, VHD: Valvular heart disease', 'unitOfMeasure': 'Participants'}, {'title': 'Blood Pressure (mmHg)', 'classes': [{'title': 'Systolic blood pressure (mmHg)', 'categories': [{'measurements': [{'value': '124.3', 'spread': '16.1', 'groupId': 'BG000'}, {'value': '126.8', 'spread': '17.3', 'groupId': 'BG001'}, {'value': '125.3', 'spread': '16.7', 'groupId': 'BG002'}]}]}, {'title': 'Diastolic blood pressure (mmHg)', 'categories': [{'measurements': [{'value': '70.7', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '70.9', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '70.8', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart Rate (beats per minute)', 'classes': [{'categories': [{'measurements': [{'value': '74.2', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '73.1', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '73.6', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kilograms)', 'classes': [{'categories': [{'measurements': [{'value': '90.8', 'spread': '21.5', 'groupId': 'BG000'}, {'value': '84.6', 'spread': '16.2', 'groupId': 'BG001'}, {'value': '87.7', 'spread': '19.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '28.5', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '29.1', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Left Ventricular ejection fraction (LVEF)', 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '58.7', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of LVEF', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-09', 'size': 1573633, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-14T09:30', 'hasProtocol': True}, {'date': '2023-03-27', 'size': 1342205, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-10-14T09:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2022-02-03', 'resultsFirstSubmitDate': '2025-10-17', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-20', 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Depression as Assessed by the Patient Health Questionnaire 8', 'timeFrame': '12 weeks after randomization', 'description': 'The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8): The 8 item questionnaire administered at 12 weeks with the following scoring system: Score range 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.\n\nNote, as an exploratory outcome, only a subgroup of participants responded to this survey request.'}, {'measure': 'Anxiety as Assessed by the Generalized Anxiety Disorder 7', 'timeFrame': '12 weeks after randomization', 'description': 'The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7): The 7-item questionnaire administered at 12 weeks follow up with the following scoring system. Each item is assigned scores of 0, 1, 2, and 3 to the response categories. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety.'}, {'measure': 'Stress as Assessed by the Perceived Stress Scale-10', 'timeFrame': '12 weeks after randomization', 'description': 'The difference in stress level as measured by Perceived Stress Scale (PSS -10): The 10 item questionnaire administered at 12 weeks follow up. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.'}, {'measure': 'Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS)', 'timeFrame': '12 weeks after randomization', 'description': 'The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS): The 8 item scale administered at 12 weeks follow up. Total scores of the eHEALS range from 8 to 40, with higher scores representing higher self-perceived (e) Health literacy.'}, {'measure': 'Patient Activation as Assessed by the Patient Activation Measure 10', 'timeFrame': '12 weeks after randomization', 'description': 'The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10): The 10-item five-point Likert scale for assessing patient activation at 12 weeks follow up, indicating whether the patient possesses the necessary knowledge, skills, and confidence needed for self-care. The total score reference range is from 0 to 100, where higher scores indicate greater patient activation and ability for self-care.'}, {'measure': 'User Engagement as Assessed by the Number of App Interactions (Intervention Group Only)', 'timeFrame': '12 weeks after randomization', 'description': 'Number of interactions in the smartphone app per participant, collected via the Corrie Health Platform User Analytics at 12 weeks follow up (only assessed in intervention arm).'}], 'primaryOutcomes': [{'measure': '6-minute Walking Distance (Meters)', 'timeFrame': '12 weeks after randomization', 'description': 'Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.'}], 'secondaryOutcomes': [{'measure': 'Composite Cardiovascular Health Metric for Secondary Prevention', 'timeFrame': '12 weeks after randomization', 'description': "The cardiovascular health metric for secondary prevention (adapted from American Heart Association's Life Simple 7). The score ranges from 0 to 14 with higher score indicating better cardiovascular health."}, {'measure': 'Blood Pressure (mmHg)', 'timeFrame': '12 weeks after randomization', 'description': 'Systolic blood pressure and Diastolic blood pressure'}, {'measure': 'Low Density Lipoprotein - Cholesterol (LDL-C)', 'timeFrame': '12 weeks after randomization', 'description': 'LDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit'}, {'measure': 'Glycosylated Hemoglobin (HbA1c)', 'timeFrame': '12 weeks after randomization', 'description': 'Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit'}, {'measure': 'Body Mass Index (kg/m^2)', 'timeFrame': '12 weeks after randomization', 'description': 'BMI = weight (kg) / height in meters squared (m\\^2). Weight and height measured by study staff at study visit.'}, {'measure': 'Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10', 'timeFrame': '12 weeks after randomization', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10: The 10-item patient-reported questionnaire administered at 12 weeks follow up in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.'}, {'measure': 'Blood Pressure Control', 'timeFrame': '12 weeks after randomization', 'description': 'Blood pressure control (Cardiovascular secondary health metric component). Ideal (SBP \\<130 mmHg and DBP \\<90 mmHg). Intermediate (SBP 130-139 mmHg or DBP 80-89 mmHg). Poor (SBP ≥140 mmHg or DBP ≥90 mmHg).'}, {'measure': 'Cholesterol (LDL-C) Control', 'timeFrame': '12 weeks after randomization', 'description': 'Cholesterol (LDL-C) control (Cardiovascular secondary health metric component). Ideal (LDL-C \\<70mg/dL). Intermediate (LDL-C 70-99 mg/dL). Poor (LDL-C ≥100mg/dL)'}, {'measure': 'Diabetes Control', 'timeFrame': '12 weeks after randomization', 'description': 'Diabetes (HbA1c) control (Cardiovascular secondary health metric component). Ideal (HbA1c \\<7% for diabetic, \\<5.7% for non-diabetic). Intermediate (HbA1c 7.0-7.9% for diabetic, 5.0-5.9% for non-diabetic). Poor (HbA1c ≥8% for diabetic, ≥6.5% for non-diabetic).'}, {'measure': 'Weight (BMI) Categories', 'timeFrame': '12 weeks after randomization', 'description': 'Weight (BMI) categories (Cardiovascular secondary health metric component). Ideal (BMI \\<25 kg/m\\^2). Intermediate (BMI 25-29 kg/m\\^2). Poor (BMI ≥ 30 kg/m\\^2).'}, {'measure': 'Physical Activity Categories', 'timeFrame': '12 weeks after randomization', 'description': 'Physical activity categories (Cardiovascular secondary health metric component). Ideal (≥150 min/wk moderate physical activity, ≥75 min/wk vigorous physical activity). Intermediate (1-149 min/wk moderate physical activity, 1-74 min/wk vigorous physical activity). Poor (No regular exercise).'}, {'measure': 'Diet Categories', 'timeFrame': '12 weeks after randomization', 'description': 'Diet categories (Cardiovascular secondary health metric component). Ideal (Rate Your Plate score 64-81). Intermediate (Rate Your Plate score 46-63). Poor (Rate Your Plate score 27-45).'}, {'measure': 'Tobacco Use', 'timeFrame': '12 weeks after randomization', 'description': 'Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker).'}, {'measure': 'Cardiac Rehabilitation Engagement', 'timeFrame': '12 weeks after randomization', 'description': 'Cardiac rehabilitation engagement as measured by number of participants who attended the sessions per category. Grouped by Healthcare Effectiveness Data and Information Set (HEDIS) categories: Initiation (0-12 sessions attended), Engagement 1 (13-24 sessions attended), Engagement 2 (25-36 sessions attended).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['digital health', 'smartphone app', 'self-management', 'guideline adherence', 'behavior modification', 'community engagement'], 'conditions': ['Coronary Artery Disease', 'Myocardial Infarction', 'Myocardial Ischemia', 'Coronary Artery Occlusion', 'Coronary Artery Stenosis Stent', 'Bypass Graft Occlusion', 'Valve Heart Disease']}, 'referencesModule': {'references': [{'pmid': '38226511', 'type': 'BACKGROUND', 'citation': 'Isakadze N, Kim CH, Marvel FA, Ding J, MacFarlane Z, Gao Y, Spaulding EM, Stewart KJ, Nimbalkar M, Bush A, Broderick A, Gallagher J, Molello N, Commodore-Mensah Y, Michos ED, Dunn P, Hanley DF, McBee N, Martin SS, Mathews L. Rationale and Design of the mTECH-Rehab Randomized Controlled Trial: Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Health. J Am Heart Assoc. 2024 Jan 16;13(2):e030654. doi: 10.1161/JAHA.123.030654. Epub 2024 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to traditional, center-based cardiac rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Individuals admitted to the hospital for the following conditions or interventions during the index admission: Acute myocardial infarction (STEMI or NSTEMI type 1), Coronary artery bypass grafting (CABG), and Coronary artery angioplasty/stenting (PCI), Heart valve surgery, catheter-based aortic valve replacement (TAVR).\n\nExclusion Criteria\n\n* Non-English speaking\n* Symptomatic severe aortic stenosis or other severe valvular disease\n* Physical disability that would preclude safe and adequate exercise performance\n* Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of \\>25 mmHg\n* Known aortic dissection\n* Severe resting arterial hypertension (Systolic blood pressure \\>200 mmHg or diastolic BP \\>110mmHg) at baseline assessment\n* Mental impairment leading to inability to cooperate with study procedures\n* Untreated high degree atrioventricular block\n* Atrial fibrillation with uncontrolled ventricular rate (Heart rate \\>110 at rest) at baseline assessment\n* History of cardiac arrest or sudden death\n* Myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia\n* Left ventricular ejection fraction \\<40%\n* History of Clinically significant depression\n* Visual or hearing impairment which precludes the use of the intervention\n* Presence of cardiac defibrillator\n* Incomplete revascularization procedure\n* History of one or more episodes of falls in the last year\n* Pregnancy\n\n * If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member may return at a later date to determine whether this status has changed.'}, 'identificationModule': {'nctId': 'NCT05238103', 'acronym': 'mTECH-Rehab', 'briefTitle': 'Impact of a Corrie Cardiac Rehabilitation Program', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Outcomes (mTECH-Rehab): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB00308410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)', 'description': 'Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.', 'interventionNames': ['Combination Product: Corrie Hybrid Cardiac Rehabilitation Program']}, {'type': 'NO_INTERVENTION', 'label': 'Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)', 'description': 'Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.'}], 'interventions': [{'name': 'Corrie Hybrid Cardiac Rehabilitation Program', 'type': 'COMBINATION_PRODUCT', 'description': 'The Corrie Hybrid Cardiac Rehabilitation Program is a multi-component intervention. It consists of the Corrie smartphone app for cardiovascular health optimization which is paired with wristband device (Apple Watch or Fitbit), Bluetooth-enabled Omron blood pressure monitor and exercise resistance bands. The program also includes individualized treatment plan development, setting health goals and communication with trained Corrie Health Coach. Furthermore, the intervention includes motivational text messages sent to participants throughout the study to aid with risk factor modification.', 'armGroupLabels': ['Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Lena Mathews, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicaltrials.gov/policy/protocol-definitions?popup=true#ipd-sharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'IPD will be made available upon request for up to 3 years from the study completion date (to 10/14/2027).', 'ipdSharing': 'YES', 'description': 'De-identified, aggregate level results, including primary and secondary outcomes, and the data dictionary will be shared through clinicaltrials.gov. Study documents (study protocol, statistical analysis plan, informed consent form, analytic code) will also be shared upon request.', 'accessCriteria': 'Researchers must submit a letter of intention and formal data request to the mTECH-Rehab principal investigator, who will review the request with the core study team and grant approval based on evaluation of merit.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}, {'name': 'Apple Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}