Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT03646760
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2018-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Improving ATTENDance to Cardiac Rehabilitation Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart 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'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sketeyian1@hfhs.org', 'phone': '313-972-1920', 'title': 'Steven Keteyian, PhD', 'organization': 'Henry Ford Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9-12 months, from the time patient enrolled into the study until they completed final study visit or 12 months from enrollment whichever came first.', 'eventGroups': [{'id': 'EG000', 'title': 'Hybrid Cardiac Rehabilitation (HYCR)', 'description': 'HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject\'s personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF\'s that are free to access from the Health System\'s web site.', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 8, 'seriousNumAtRisk': 142, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Center Based Cardiac Rehabilitation (CBCR)', 'description': "CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).", 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 3, 'seriousNumAtRisk': 140, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Unstable Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hybrid Cardiac Rehabilitation (HYCR)', 'description': 'HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject\'s personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF\'s that are free to access from the Health System\'s web site.'}, {'id': 'OG001', 'title': 'Center Based Cardiac Rehabilitation (CBCR)', 'description': "CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians)."}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'unitOfMeasure': 'Number of cardiac rehab sessions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients Completing 36 CR Sessions Within 6 Months Among Patients Randomized to the HYCR Program vs. Patients Randomized to the CBCR Program.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hybrid Cardiac Rehabilitation (HYCR)', 'description': 'HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject\'s personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF\'s that are free to access from the Health System\'s web site.'}, {'id': 'OG001', 'title': 'Center Based Cardiac Rehabilitation (CBCR)', 'description': "CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians)."}], 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000'}, {'value': '50.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 6 months', 'description': 'Outcome measure is the percent of people who complete all 36 CR sessions and the mean value reported represents the average percentage for all patients in both study groups.', 'unitOfMeasure': '% of patients completing 36 sessions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improvement in Exercise Capacity, as Measured by Distance Walked During the Six Min Walk (6MW) Test, in Patients Randomized to HYCR vs Patients Randomized to CBCR.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hybrid Cardiac Rehabilitation (HYCR)', 'description': 'HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject\'s personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF\'s that are free to access from the Health System\'s web site.'}, {'id': 'OG001', 'title': 'Center Based Cardiac Rehabilitation (CBCR)', 'description': "CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians)."}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '46', 'groupId': 'OG000'}, {'value': '50', 'spread': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Improvement in exercise capacity was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses represent complete cases for Center Based Only CR and Hybrid CR'}, {'type': 'SECONDARY', 'title': 'Improvement in Exercise Capacity, as Measured by Peak Oxygen Uptake (VO2), in Patients Randomized to HYCR vs Patients Randomized to CBCR.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hybrid Cardiac Rehabilitation (HYCR)', 'description': 'HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject\'s personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF\'s that are free to access from the Health System\'s web site.'}, {'id': 'OG001', 'title': 'Center Based Cardiac Rehabilitation (CBCR)', 'description': "CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians)."}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': 'Improvement in exercise capacity was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses represent complete cases for Center Based Only CR and Hybrid CR'}, {'type': 'SECONDARY', 'title': 'Improvement in Quality of Life (QOL), as Measured by the Total Score for Dartmouth COOP, in Patients Randomized to HYCR vs Patients Randomized to CBCR.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hybrid Cardiac Rehabilitation (HYCR)', 'description': 'HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject\'s personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF\'s that are free to access from the Health System\'s web site.'}, {'id': 'OG001', 'title': 'Center Based Cardiac Rehabilitation (CBCR)', 'description': "CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians)."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months', 'description': '5-point Likert-type scaling, with 1 being more positive and 5 being more negative. Lower scores indicate higher levels of quality of life.\n\nImprovement in qualify of life was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses represent complete cases for Center Based Only CR and Hybrid CR'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hybrid Cardiac Rehabilitation (HYCR)', 'description': 'HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject\'s personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF\'s that are free to access from the Health System\'s web site.'}, {'id': 'FG001', 'title': 'Center Based Cardiac Rehabilitation (CBCR)', 'description': "CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '62'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hybrid Cardiac Rehabilitation (HYCR)', 'description': 'HYCR: This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject\'s personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF\'s that are free to access from the Health System\'s web site.'}, {'id': 'BG001', 'title': 'Center Based Cardiac Rehabilitation (CBCR)', 'description': "CBCR: This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians)."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', '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': '76', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-25', 'size': 521543, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-15T13:03', 'hasProtocol': True}, {'date': '2022-06-24', 'size': 188097, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-15T13:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2018-08-14', 'resultsFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-28', 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care).', 'timeFrame': 'Baseline to 6 months'}, {'measure': 'Percentage of Patients Completing 36 CR Sessions Within 6 Months Among Patients Randomized to the HYCR Program vs. Patients Randomized to the CBCR Program.', 'timeFrame': 'Baseline to 6 months', 'description': 'Outcome measure is the percent of people who complete all 36 CR sessions and the mean value reported represents the average percentage for all patients in both study groups.'}], 'secondaryOutcomes': [{'measure': 'Improvement in Exercise Capacity, as Measured by Distance Walked During the Six Min Walk (6MW) Test, in Patients Randomized to HYCR vs Patients Randomized to CBCR.', 'timeFrame': 'Baseline to 6 months', 'description': 'Improvement in exercise capacity was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).'}, {'measure': 'Improvement in Exercise Capacity, as Measured by Peak Oxygen Uptake (VO2), in Patients Randomized to HYCR vs Patients Randomized to CBCR.', 'timeFrame': 'Baseline to 6 months', 'description': 'Improvement in exercise capacity was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).'}, {'measure': 'Improvement in Quality of Life (QOL), as Measured by the Total Score for Dartmouth COOP, in Patients Randomized to HYCR vs Patients Randomized to CBCR.', 'timeFrame': 'Baseline to 6 months', 'description': '5-point Likert-type scaling, with 1 being more positive and 5 being more negative. Lower scores indicate higher levels of quality of life.\n\nImprovement in qualify of life was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Heart Failure', 'Heart Valve Diseases', 'Cardiac Event', 'Angina Pectoris', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '38670326', 'type': 'DERIVED', 'citation': 'Keteyian SJ, Grimshaw C, Ehrman JK, Kerrigan DJ, Abdul-Nour K, Lanfear DE, Brawner CA. The iATTEND Trial: A Trial Comparing Hybrid Versus Standard Cardiac Rehabilitation. Am J Cardiol. 2024 Jun 15;221:94-101. doi: 10.1016/j.amjcard.2024.04.034. Epub 2024 Apr 25.'}, {'pmid': '33351540', 'type': 'DERIVED', 'citation': 'Keteyian SJ, Grimshaw C, Brawner CA, Kerrigan DJ, Reasons L, Berry R, Peterson EL, Ehrman JK. A Comparison of Exercise Intensity in Hybrid Versus Standard Phase Two Cardiac Rehabilitation. J Cardiopulm Rehabil Prev. 2021 Jan 1;41(1):19-22. doi: 10.1097/HCR.0000000000000569.'}]}, 'descriptionModule': {'briefSummary': 'The benefits of cardiac rehabilitation are well known. However, despite center based cardiac rehabilitation (CBCR) representing guideline-based care for patients with cardiovascular disease, most patients do not complete the maximum number of sessions allowed by third party insurance payers. As such, many patients may not be receiving the full clinical benefit ascribed to CR. This study will assess the efficacy of an innovative approach to CR delivery on attendance by combining both center-based and remote- or home-based CR sessions. The intervention group combines center-based CR and remote-/home-based CR and is tailored to the individual needs of each patient, accomplished with the assistance of an easy-to-access telecommunications methodology (telemedicine)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has agreed to participate in CR and has experienced a cardiac event (myocardial infraction, coronary revascularization, heart valve surgery, or cardiac transplant in the past 6 months; diagnosed with chronic, stable AHA/ACC stage B or C heart failure or Canadian class 0-2 stable angina pectoris)\n2. Lives in or plans to remain in the greater Detroit, MI area for the next year\n3. Age 18-85 years of age\n4. Agrees to attend at least one CBCR session\n5. Agrees to scheduling at least 2, up to 3, CR sessions (either CBCR or HYCR)/wk\n6. Has demonstrated to research staff their ability to access and connect to the internet via smart phone or tablet and already has access to satisfactory home- or community-based exercise equipment\n\nExclusion Criteria:\n\n1. Received a left ventricular assist device, receiving continuous inotropic support (e.g., milrinone), or undergoing hemodialysis\n2. Angina at rest or with a low functional capacity (\\< 2 METs)\n3. Advanced cancer, advanced risk for falling, limiting cognitive impairment, or other advanced disorder that limits participation in CR\n\n 1. Advanced risk for falling will be assessed by 5X sit-to-stand test, with a cut-off score of \\>15 seconds\n 2. Cognitive assessment will be completed using the Mini-Cog instrument, with a cut-off score \\< 3 used to exclude potential subjects.\n4. Severe arrhythmia unless adequately treated (e.g., implantable cardiac defibrillator)\n5. Pregnant or plan to become pregnant in the next year.\n6. Major cardiovascular procedure or hospitalization planned in the next 6 months\n7. Less than 12 month life expectancy\n8. Participation in another clinical trial that interferes with iATTEND participation, follow-up, data collection, exercise capacity or quality of life.'}, 'identificationModule': {'nctId': 'NCT03646760', 'acronym': 'iATTEND', 'briefTitle': 'The Improving ATTENDance to Cardiac Rehabilitation Trial', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'The Improving ATTENDance to Cardiac Rehabilitation Trial', 'orgStudyIdInfo': {'id': 'HFHS iATTEND'}, 'secondaryIdInfos': [{'id': 'R33HL143099', 'link': 'https://reporter.nih.gov/quickSearch/R33HL143099', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hybrid Cardiac Rehabilitation (HYCR)', 'interventionNames': ['Behavioral: HYCR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Center Based cardiac Rehabilitation (CBCR)', 'interventionNames': ['Behavioral: CBCR']}], 'interventions': [{'name': 'HYCR', 'type': 'BEHAVIORAL', 'description': 'This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject\'s personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF\'s that are free to access from the Health System\'s web site.', 'armGroupLabels': ['Hybrid Cardiac Rehabilitation (HYCR)']}, {'name': 'CBCR', 'type': 'BEHAVIORAL', 'description': "This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).", 'armGroupLabels': ['Center Based cardiac Rehabilitation (CBCR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Steven Keteyian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Steven J. Keteyian', 'investigatorAffiliation': 'Henry Ford Health System'}}}}