Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-02-27 @ 11:18 AM
Study NCT ID:
NCT03073005
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2017-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Simulation to Improve VAD Self-management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbarsuk@nm.org', 'phone': '312-926-5924', 'title': 'Dr. Jeffrey H Barsuk', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year post patient discharge', 'description': 'NOTE: All-Cause Mortality, Serious, and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed in "Traditional VAD Training (Caregivers)" and "Simulation-based VAD Training (Caregivers)" participants because they are not followed clinically as part of this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Traditional VAD Training (Patients)', 'description': 'Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Simulation-based VAD Training (Patients)', 'description': 'Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional VAD Training (Patients)', 'description': 'Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'OG001', 'title': 'Traditional VAD Training (Caregivers)', 'description': 'Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'OG002', 'title': 'Simulation-based VAD Training (Patients)', 'description': 'Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}, {'id': 'OG003', 'title': 'Simulation-based VAD Training (Caregivers)', 'description': 'Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}], 'classes': [{'title': 'Written examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '100'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '97.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '97.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100'}]}]}, {'title': 'Controller change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000', 'lowerLimit': '78.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'Power source change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '88.9', 'upperLimit': '88.9'}, {'value': '88.9', 'groupId': 'OG001', 'lowerLimit': '88.9', 'upperLimit': '96.2'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'Dressing change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG001', 'lowerLimit': '68.8', 'upperLimit': '87.5'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'The investigators will compare the performance of the SBML intervention group to the usual VAD training group during actual VAD care activities (controller change, power source change and dressing change) plus a written examination. Only caregivers were assessed on dressing change as patients do not independently complete this task.', 'unitOfMeasure': 'percentage of checklist items correct', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient and caregiver pairs were included if both the patient and their caregiver completed training and assessments through discharge testing. (\\*Note- Only caregivers were assessed on dressing change as patients do not independently complete this task.)'}, {'type': 'SECONDARY', 'title': 'Infections and Re-hospitalizations up to 3 Months After VAD Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional VAD Training (Patients)', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'OG001', 'title': 'Simulation-based VAD Training (Patients)', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}], 'classes': [{'title': 'Infections', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Re-hospitalizations', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after discharge', 'description': 'All VAD related driveline infections and re-hospitalizations between the SBML intervention group as compared to the usual VAD training group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is for patients only'}, {'type': 'SECONDARY', 'title': 'Self-management Skill Decay in the Five Domains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional VAD Training (Patients)', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'OG001', 'title': 'Traditional VAD Training (Caregivers)', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'OG002', 'title': 'Simulation-based VAD Training (Patients)', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}, {'id': 'OG003', 'title': 'Simulation-based VAD Training (Caregivers)', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}], 'classes': [{'title': 'One month controller change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG002', 'lowerLimit': '78.57', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'One month power source change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG002', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'One month dressing change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG003', 'lowerLimit': '90.63', 'upperLimit': '100'}]}]}, {'title': '3 month controller change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85.71', 'groupId': 'OG000', 'lowerLimit': '62.50', 'upperLimit': '100'}, {'value': '78.57', 'groupId': 'OG001', 'lowerLimit': '28.57', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '78.57', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '3 month power source change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.89', 'groupId': 'OG000', 'lowerLimit': '88.89', 'upperLimit': '97.22'}, {'value': '88.89', 'groupId': 'OG001', 'lowerLimit': '88.89', 'upperLimit': '88.89'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': '3 month dressing change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.13', 'groupId': 'OG001', 'lowerLimit': '67.99', 'upperLimit': '86.42'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '93.75', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 month and 3 months after discharge (*1 month SBML-trained only)', 'description': 'The investigators will measure the change in skill decay on the patient from 0 (time of implant), one and three months using VAD self-management checklists (controller change, power source change and dressing change) throughout the study period.', 'unitOfMeasure': 'percentage of checklist items correct', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 49 patient and caregiver pairs who completed discharge testing, 15 patient and caregiver pairs in the SBML group completed 1 month and 3 month followup testing and 20 pairs in the usual care group completed 3 month follow-up testing only.'}, {'type': 'SECONDARY', 'title': 'Comparisons of Self-confidence Between Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Traditional VAD Training (Patients)', 'description': 'Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'OG001', 'title': 'Traditional VAD Training (Caregivers)', 'description': 'Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'OG002', 'title': 'Simulation-based VAD Training (Patients)', 'description': 'Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}, {'id': 'OG003', 'title': 'Simulation-based VAD Training (Caregivers)', 'description': 'Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}], 'classes': [{'title': 'VAD Driveline exit site sterile dressing changes', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '65'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '87.5'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': 'Changing the VAD controller during emergencies', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '72.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '95', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '92.5', 'upperLimit': '100'}]}]}, {'title': 'Changing power sources on the VAD', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'Troubleshooting emergency VAD-related malfunction', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '100'}, {'value': '90', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '72.5', 'upperLimit': '100'}]}]}, {'title': 'Recognizing VAD-specific signs and symptoms', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '92.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '90', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'Simulation-based Mastery Learning (SBML) Trained and Usual Trained Patient and Caregiver Reported Self-Confidence (0=very low confidence to 100=very high confidence) before Discharge Testing on Five VAD Skills.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'patients and caregiver who completed training through hospital discharge'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Traditional VAD Training (Patients)', 'description': 'Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'FG001', 'title': 'Traditional VAD Training (Caregivers)', 'description': 'Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'FG002', 'title': 'Simulation-based VAD Training (Patients)', 'description': 'Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}, {'id': 'FG003', 'title': 'Simulation-based VAD Training (Caregivers)', 'description': 'Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '37'}]}, {'type': 'Received Initial Training', 'achievements': [{'comment': '29 pairs (29 patients plus their caregivers)', 'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'comment': '33 pairs (33 patients plus their caregivers)', 'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'comment': 'Completed entire protocol thru discharge testing', 'achievements': [{'comment': '25 pairs (25 patients plus their caregivers)', 'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'comment': '24 pairs (24 patients plus their caregivers)', 'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'caregiver withdrew bc of pt death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Traditional VAD Training (Patients)', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'BG001', 'title': 'Traditional VAD Training (Caregivers)', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'id': 'BG002', 'title': 'Simulation-based VAD Training (Patients)', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}, {'id': 'BG003', 'title': 'Simulation-based VAD Training (Caregivers)', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management\n\nSimulation-based Mastery Learning (SBML): The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '54.91', 'spread': '13.25', 'groupId': 'BG000'}, {'value': '53.43', 'spread': '14.95', 'groupId': 'BG001'}, {'value': '51.33', 'spread': '14.54', 'groupId': 'BG002'}, {'value': '55.28', 'spread': '12.68', 'groupId': 'BG003'}, {'value': '53.71', 'spread': '13.85', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline VAD Checklist Skills', 'classes': [{'title': 'Controller change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '21.42', 'groupId': 'BG002', 'lowerLimit': '1.79', 'upperLimit': '33.93'}, {'value': '28.57', 'groupId': 'BG003', 'lowerLimit': '21.43', 'upperLimit': '66.07'}, {'value': '24.04', 'groupId': 'BG004', 'lowerLimit': '9.82', 'upperLimit': '48.21'}]}]}, {'title': 'Power source change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '22.22', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '66.67'}, {'value': '76.39', 'groupId': 'BG003', 'lowerLimit': '38.46', 'upperLimit': '88.89'}, {'value': '55.56', 'groupId': 'BG004', 'lowerLimit': '0', 'upperLimit': '88.89'}]}]}, {'title': 'Dressing change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '23.44', 'groupId': 'BG003', 'lowerLimit': '10.16', 'upperLimit': '32.01'}, {'value': '23.44', 'groupId': 'BG004', 'lowerLimit': '10.16', 'upperLimit': '32.01'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline skills assessed via checklists for SBML-trained patients and caregivers ONLY on controller change, power source change and dressing change (caregiver only). Scored in terms of percent checklist items correct.', 'unitOfMeasure': 'percent of items correct on checklist', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'ONLY SBML-trained patients and caregivers took a baseline exam. Traditionally-trained patients and caregivers scores in the study were considered their "baseline". Those are reported in the outcomes section.\n\n\\*dressing change is for caregivers only'}], 'populationDescription': 'in order to be considered for final analysis both the patient participant plus their caregiver (pairs) must still be enrolled in the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-03', 'size': 219828, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-09T14:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2017-02-20', 'resultsFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2017-03-02', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-07', 'studyFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups', 'timeFrame': '3 months', 'description': 'The investigators will compare the performance of the SBML intervention group to the usual VAD training group during actual VAD care activities (controller change, power source change and dressing change) plus a written examination. Only caregivers were assessed on dressing change as patients do not independently complete this task.'}], 'secondaryOutcomes': [{'measure': 'Infections and Re-hospitalizations up to 3 Months After VAD Implant', 'timeFrame': '3 months after discharge', 'description': 'All VAD related driveline infections and re-hospitalizations between the SBML intervention group as compared to the usual VAD training group'}, {'measure': 'Self-management Skill Decay in the Five Domains', 'timeFrame': '1 month and 3 months after discharge (*1 month SBML-trained only)', 'description': 'The investigators will measure the change in skill decay on the patient from 0 (time of implant), one and three months using VAD self-management checklists (controller change, power source change and dressing change) throughout the study period.'}, {'measure': 'Comparisons of Self-confidence Between Groups', 'timeFrame': '3 months', 'description': 'Simulation-based Mastery Learning (SBML) Trained and Usual Trained Patient and Caregiver Reported Self-Confidence (0=very low confidence to 100=very high confidence) before Discharge Testing on Five VAD Skills.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ventricular assist device (VAD)', 'heart failure', 'simulation'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '31601111', 'type': 'DERIVED', 'citation': 'Barsuk JH, Wilcox JE, Cohen ER, Harap RS, Shanklin KB, Grady KL, Kim JS, Nonog GP, Schulze LE, Jirak AM, Wayne DB, Cameron KA. Simulation-Based Mastery Learning Improves Patient and Caregiver Ventricular Assist Device Self-Care Skills: A Randomized Pilot Trial. Circ Cardiovasc Qual Outcomes. 2019 Oct;12(10):e005794. doi: 10.1161/CIRCOUTCOMES.119.005794. Epub 2019 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the performance of a curriculum using medical simulators to train patients with advanced heart failure and their caregivers to master the self-management of ventricular assist devices (a device implanted into the heart to help circulate the blood). The investigators expect this training will improve self-management skills, and reduce VAD-related infections and re-hospitalizations. In addition to providing innovative training to the patients and their caregivers, the study will advance our knowledge of the effects of simulation-based training on patient self-management and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* being a previous or current VAD implantation patient,\n* age \\>18,\n* English-speaking,\n* receiving implantation and VAD care at Northwestern Memorial Hospital (NMH),\n* meet hospital criteria for VAD implantation.\n\nCaregiver inclusion criteria:\n\n* being a caregiver identified by a previous or current VAD implantation patient,\n* age \\>18, and\n* English-speaking.\n\nExclusion Criteria:\n\n* Vulnerable populations of patients will not be included in this study (including fetuses, neonates, children, pregnant women, prisoners, mentally retarded or incompetent individuals, institutionalized individuals, or individuals unable to give consent due to their medical condition). Fetuses and neonates are not the focus of our study.\n* Pregnant women will not be included since pregnancy is a contraindication to VAD implantation It is possible that VAD caregivers may be pregnant at the time of the study.\n* Patients with mental retardation, mental incompetence, or patients who are unable to give consent due to their medical condition will not be included as they will not be able to complete measures.\n* Lastly, institutionalized individuals will not be included as access will be a problem, and these individuals are rarely referred for VAD implantation'}, 'identificationModule': {'nctId': 'NCT03073005', 'acronym': 'SimVAD', 'briefTitle': 'Use of Simulation to Improve VAD Self-management', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Use of Simulation to Improve Ventricular Assist Device Self-management', 'orgStudyIdInfo': {'id': 'STU00203530'}, 'secondaryIdInfos': [{'id': '5R21NR016745-02', 'link': 'https://reporter.nih.gov/quickSearch/5R21NR016745-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Traditional VAD training', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.'}, {'type': 'EXPERIMENTAL', 'label': 'Simulation-based VAD training', 'description': 'Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management', 'interventionNames': ['Other: Simulation-based Mastery Learning (SBML)']}], 'interventions': [{'name': 'Simulation-based Mastery Learning (SBML)', 'type': 'OTHER', 'description': 'The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.', 'armGroupLabels': ['Simulation-based VAD training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jeffrey Barsuk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeffrey Barsuk', 'investigatorAffiliation': 'Northwestern University'}}}}