Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT03657459
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2018-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Danger Signs in Heart Failure- Effects of Video Education
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': 'albertn@ccf.org', 'phone': '216-444-7028', 'title': 'Nancy M. Albert PhD, CCNS, CHFN, CCRN, NE-BC, FAHA, FCCM, FHFSA, FAAN', 'phoneExt': '47028', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events recorded for this study were NON-treatment-related. Patient charts were monitored at 180 days (6 months) and considered to be non-direct patient outcomes becasue of the nature of participants medical condition, in general.', 'description': 'Adverse events were NON-treatment-related as the intervention was video education. The IRB approved this study as minimal risk and adverse events were NOT collected or recorded except those believed to be important indirect (no direct) heart failure and all-cause 180 day outcomes (death, emaergency department visits and hospitalizations). Patient charts were monitored for the above outcomes at180 days (6 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs", 'otherNumAtRisk': 377, 'deathsNumAtRisk': 377, 'otherNumAffected': 0, 'seriousNumAtRisk': 377, 'deathsNumAffected': 42, 'seriousNumAffected': 232}, {'id': 'EG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch short videos from Wellflix, Inc.: 1) "Danger Signs of Heart Failure" videos (via iPAD) on dyspnea and fatigue; and 2) "Danger Signs edema" video. Each video describes how to recognize if the patient\'s signs/symptoms are new or worsening and how to self-manage at home via diet, fluid management, and physical activity instructions.\n\nDanger Signs of Heart Failure Videos are short videos (less than 3 minutes each). The videos contain educational information on (a) recognition of dyspnea, fatigue, and edema; and (b) self-management (based on diet, fluid management, and activities)', 'otherNumAtRisk': 369, 'deathsNumAtRisk': 369, 'otherNumAffected': 0, 'seriousNumAtRisk': 369, 'deathsNumAffected': 40, 'seriousNumAffected': 242}], 'seriousEvents': [{'term': 'All-cause 180 day emergency department, hospitalization, transplant/left ventricular assist device o', 'notes': 'Events were considered non-direct in relation to the education video as education is an INDIRECT effect of all-cuase related outcomes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 377, 'numAffected': 232}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 242}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With HF-related Healthcare Resource Utilization (HCRU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'Total number of participants post-discharge with HF-related hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related ED Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'Number of participants with post-discharge HF-related ED visits', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'Number of participants post-discharge with HF-related death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related Healthcare Resource Utilization (HCRU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with HF-related hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related ED Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with HF-related ED visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with HF-related death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related Healthcare Resource Utilization (HCRU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with HF-related hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related ED Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with HF-related ED visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HF-related Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with HF-related death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Healthcare Resource Utilization (HCRU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'Number of participants post-discharge with all-cause hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause ED Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with post-discharge all-cause ED visits', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'Number of participants post-discharge with all-cause deaths', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Healthcare Resource Utilization (HCRU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 90 days', 'description': 'Number of participants with post-discharge all-cause hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause ED Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with all-cause ED visits', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with all-cause death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Healthcare Resource Utilization (HCRU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with all-cause hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All-cause ED Visits at 180 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0096', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pearsons Chi Square'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with all-cause ED visits', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All-cause Death at 180 Days Post Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'no adjustment', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pearson Chi-square'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with all-cause death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 30 days', 'description': "Duke Activity Status Index (DASI) score at 30 days. Patients completed the DASI, a 12-item questionnaire using a Likert-like scale that determines a patient's ability to participate in daily self-care activities including ambulation, housework, yard work, sexual relations, and recreational activities. A total score reflects functional status based on responses. The full range of scores is 0 (most severe functional impairment) to 58.2 (no functional impairment). There is no established cut-point for this scale. Positive, higher scores reflect a positive and better functional status.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed in both groups was lower than the number enrolled. This is due to the research team being unable to contact some patients by phone for study follow-up or the patient was deceased (medical record chart review).'}, {'type': 'SECONDARY', 'title': 'Dyspnea at 30 Days Post Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '46.1', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '45.8', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'PROMIS® Dyspnea Functional Limitations - Short Form 10a was used. It is a 10-item tool that measures dyspnea by asking 10 questions about the difficulty in completing activities in the past 7 days. Responses range from "0 = no difficulty" to "3 = much difficulty" and there is an option for "I did not do this in the past 7 days" - there were 5 response options in total. Minimum and maximum raw scores are 0-30. PROMIS T scores are standardized with scores around 50 (standard deviation of 10) equating to normal/average levels and scores above or below equating to heightening or lessening of the variable being measured. A 5 point change in score is considered significant. A table is used to translate the total raw score to T score for each participant.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed in both groups was lower than the number enrolled. This is due to the research team being unable to contact some patients by phone for study follow-up or the patient was deceased (medical record chart review).'}, {'type': 'SECONDARY', 'title': 'Fatigue at 30 Days Post Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'to 30 days', 'description': '10-item Fatigue Assessment Scale from baseline. The Fatigue Assessment Scale is a valid, reliable 10-item scale evaluating symptoms of chronic fatigue. It uses Likert-type response options ranging from 1 ("never") to 5 ("always"), with some items reverse scored. Total scores range from 10 (lowest level of fatigue) to 50 (highest level of fatigue).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed in both groups was lower than the number enrolled. This is due to the research team being unable to contact some patients by phone for study follow-up or the patient was deceased (medical record chart review).'}, {'type': 'SECONDARY', 'title': 'Self-efficacy for Managing Symptoms at 30 Days Post Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'OG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '43.4', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline. 8-item tool that ranges from \'I am not at all confident\' to \'I am very confident" - higher scores equals higher self-efficacy. A mean score of 50 is the average score in the general population of U.S. with standard deviation of 10. A table is used to translate the total raw score to T score for each participant. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores (above 50) reflect better than average self-efficacy', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed in both groups was lower than the number enrolled. This is due to the research team being unable to contact some patients by phone for study follow-up or the patient was deceased (medical record).'}, {'type': 'SECONDARY', 'title': 'Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Education Group - Never Watched Video at Home', 'description': 'Video delivered and watched during hospitalization but never watched at home'}, {'id': 'OG001', 'title': 'Video Education Group - Watched 1+ Time at Home', 'description': 'Video delivered and watched during hospitalization, and watched 1+ or more times at home'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Among intervention group participants, total number of all-cause events within 30 days of discharge, based on the number of times the patient watched the video education. Participant responses are grouped into two categories: Never watched vs. 1 or more times', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed (n=304) was lower than the number enrolled due to inability to contact some patients by phone for study follow-up or the patient was deceased (as a note, this info was not available in the medical record).'}, {'type': 'SECONDARY', 'title': 'Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Education Group - NO, Family Never Watched', 'description': 'Video education group but family member never reviewed video content'}, {'id': 'OG001', 'title': 'Video Education Group - YES, Family Watched', 'description': 'Video education group and family member reviewed video content at least 1 time'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Total number of participants (video education group only), comparison of all-cause events within 30 days of discharge, based on family members watching the educational videos after the hospital (Yes/No).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'FG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '377'}, {'groupId': 'FG001', 'numSubjects': '369'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '377'}, {'groupId': 'FG001', 'numSubjects': '369'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Adult patients with decompensated HF, with preserved or reduced ejection fraction when hospitalized and New York Heart Association FC III or ambulatory IV symptoms, were recruited for this study between July 2018 to November 2020.', 'preAssignmentDetails': 'In total, 746 patients started/completed study (377 patients randomized to usual care and 369 intervention).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '746', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care Group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'id': 'BG001', 'title': 'Video Education Group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)\n\nDanger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '67.7', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '68.0', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '417', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', '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': '116', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '253', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '496', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '377', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '746', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Marital status', 'classes': [{'title': 'Single', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}, {'title': 'Married, living with partner', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '347', 'groupId': 'BG002'}]}]}, {'title': 'Divorced/separated/widowed', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}, {'title': 'Living with child or another person not a spouse or partner', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Someone who supports you', 'classes': [{'title': 'No, not needed', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'No, no supporter available', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Yes, have a support person', 'categories': [{'measurements': [{'value': '340', 'groupId': 'BG000'}, {'value': '339', 'groupId': 'BG001'}, {'value': '679', 'groupId': 'BG002'}]}]}, {'title': 'Missing survey response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Someone to confide in', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '362', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '720', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest level of education completed', 'classes': [{'title': 'High school or less', 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}]}, {'title': 'Some college', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}, {'title': 'Bachelor/Associate/Professional degree', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}, {'title': 'Master/Doctoral degree', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Missing survey response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment status', 'classes': [{'title': 'Employed full or part-time outside home', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': 'Unemployed by choice or homemaker', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Sick leave or disability or retired due to HF', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': 'Retired, not due to HF', 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '427', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Consider how well you live on income', 'classes': [{'title': 'Comfortable, have more than enough to make ends meet', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}, {'title': 'Have enough to make ends meet', 'categories': [{'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}]}, {'title': 'Do not have enough to make ends meet', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}, {'title': 'Missing survey response', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'groupId': 'BG000', 'lowerLimit': '26.0', 'upperLimit': '38.9'}, {'value': '31.5', 'groupId': 'BG001', 'lowerLimit': '25.8', 'upperLimit': '38.6'}, {'value': '31.9', 'groupId': 'BG002', 'lowerLimit': '25.9', 'upperLimit': '38.8'}]}]}], 'paramType': 'MEDIAN', 'description': 'measures the ratio of height to weight to estimate the amount of body fat a person has. BMI is calculated by using weight in kilograms (kg) divided by the square of height in meters (m2) \\[kg/m2\\].', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Insurance', 'classes': [{'title': 'Government', 'categories': [{'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}]}, {'title': 'Commercial', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'HMO', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Government and commercial', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Government and HMO', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'How far away in miles is your home to the office/clinic?', 'classes': [{'title': 'Under 5 miles', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}, {'title': 'Over 5 miles but under 15 miles', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}]}, {'title': '15 miles or over 20 minutes', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}]}, {'title': 'I have not seen a HF medical provider in >1 year', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Do not know the distance', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Missing survey response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'How far away in miles is your home to the hospital', 'classes': [{'title': 'Under 5 miles', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}]}, {'title': 'Over 5 miles but under 15 miles', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}, {'title': '15 miles or over 20 minutes', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}, {'title': 'I have not seen a HF medical provider in >1 year', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Do not know the distance', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'In general would you say your health is', 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Very good', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}, {'title': 'Missing survey response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-07', 'size': 268828, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-29T16:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Documentation of enrollment will not include group assignment Investigator will be blinded from group assignment via a separate excel file with that detail'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled prospective trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 746}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2018-08-30', 'resultsFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2018-09-02', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-22', 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With HF-related Healthcare Resource Utilization (HCRU)', 'timeFrame': 'up to 30 days', 'description': 'Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With HF-related Hospitalization', 'timeFrame': 'up to 30 days', 'description': 'Total number of participants post-discharge with HF-related hospitalization'}, {'measure': 'Number of Participants With HF-related ED Visits', 'timeFrame': 'up to 30 days', 'description': 'Number of participants with post-discharge HF-related ED visits'}, {'measure': 'Number of Participants With HF-related Death', 'timeFrame': 'up to 30 days', 'description': 'Number of participants post-discharge with HF-related death'}, {'measure': 'Number of Participants With HF-related Healthcare Resource Utilization (HCRU)', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.'}, {'measure': 'Number of Participants With HF-related Hospitalization', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with HF-related hospitalization'}, {'measure': 'Number of Participants With HF-related ED Visit', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with HF-related ED visit'}, {'measure': 'Number of Participants With HF-related Death', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with HF-related death'}, {'measure': 'Number of Participants With HF-related Healthcare Resource Utilization (HCRU)', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.'}, {'measure': 'Number of Participants With HF-related Hospitalization', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with HF-related hospitalization'}, {'measure': 'Number of Participants With HF-related ED Visit', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with HF-related ED visit'}, {'measure': 'Number of Participants With HF-related Death', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with HF-related death'}, {'measure': 'Number of Participants With All-cause Healthcare Resource Utilization (HCRU)', 'timeFrame': 'up to 30 days', 'description': 'Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.'}, {'measure': 'Number of Participants With All-cause Hospitalization', 'timeFrame': 'up to 30 days', 'description': 'Number of participants post-discharge with all-cause hospitalization'}, {'measure': 'Number of Participants With All-cause ED Visits', 'timeFrame': '30 days', 'description': 'Number of participants with post-discharge all-cause ED visits'}, {'measure': 'Number of Participants With All-cause Death', 'timeFrame': 'up to 30 days', 'description': 'Number of participants post-discharge with all-cause deaths'}, {'measure': 'Number of Participants With All-cause Healthcare Resource Utilization (HCRU)', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.'}, {'measure': 'Number of Participants With All-cause Hospitalization', 'timeFrame': 'up to 90 days', 'description': 'Number of participants with post-discharge all-cause hospitalization'}, {'measure': 'Number of Participants With All-cause ED Visits', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with all-cause ED visits'}, {'measure': 'Number of Participants With All-cause Death', 'timeFrame': 'up to 90 days', 'description': 'Number of participants post-discharge with all-cause death'}, {'measure': 'Number of Participants With All-cause Healthcare Resource Utilization (HCRU)', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.'}, {'measure': 'Number of Participants With All-cause Hospitalization', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with all-cause hospitalization'}, {'measure': 'All-cause ED Visits at 180 Days', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with all-cause ED visits'}, {'measure': 'All-cause Death at 180 Days Post Discharge', 'timeFrame': 'up to 180 days', 'description': 'Number of participants post-discharge with all-cause death'}, {'measure': 'Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge', 'timeFrame': 'up to 30 days', 'description': "Duke Activity Status Index (DASI) score at 30 days. Patients completed the DASI, a 12-item questionnaire using a Likert-like scale that determines a patient's ability to participate in daily self-care activities including ambulation, housework, yard work, sexual relations, and recreational activities. A total score reflects functional status based on responses. The full range of scores is 0 (most severe functional impairment) to 58.2 (no functional impairment). There is no established cut-point for this scale. Positive, higher scores reflect a positive and better functional status."}, {'measure': 'Dyspnea at 30 Days Post Discharge', 'timeFrame': '30 days', 'description': 'PROMIS® Dyspnea Functional Limitations - Short Form 10a was used. It is a 10-item tool that measures dyspnea by asking 10 questions about the difficulty in completing activities in the past 7 days. Responses range from "0 = no difficulty" to "3 = much difficulty" and there is an option for "I did not do this in the past 7 days" - there were 5 response options in total. Minimum and maximum raw scores are 0-30. PROMIS T scores are standardized with scores around 50 (standard deviation of 10) equating to normal/average levels and scores above or below equating to heightening or lessening of the variable being measured. A 5 point change in score is considered significant. A table is used to translate the total raw score to T score for each participant.'}, {'measure': 'Fatigue at 30 Days Post Discharge', 'timeFrame': 'to 30 days', 'description': '10-item Fatigue Assessment Scale from baseline. The Fatigue Assessment Scale is a valid, reliable 10-item scale evaluating symptoms of chronic fatigue. It uses Likert-type response options ranging from 1 ("never") to 5 ("always"), with some items reverse scored. Total scores range from 10 (lowest level of fatigue) to 50 (highest level of fatigue).'}, {'measure': 'Self-efficacy for Managing Symptoms at 30 Days Post Discharge', 'timeFrame': '30 days', 'description': 'PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline. 8-item tool that ranges from \'I am not at all confident\' to \'I am very confident" - higher scores equals higher self-efficacy. A mean score of 50 is the average score in the general population of U.S. with standard deviation of 10. A table is used to translate the total raw score to T score for each participant. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores (above 50) reflect better than average self-efficacy'}, {'measure': 'Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)', 'timeFrame': '30 days', 'description': 'Among intervention group participants, total number of all-cause events within 30 days of discharge, based on the number of times the patient watched the video education. Participant responses are grouped into two categories: Never watched vs. 1 or more times'}, {'measure': 'Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no)', 'timeFrame': '30 days', 'description': 'Total number of participants (video education group only), comparison of all-cause events within 30 days of discharge, based on family members watching the educational videos after the hospital (Yes/No).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['video education', 'self care management', 'symptom recognition'], 'conditions': ['Heart Failure; With Decompensation']}, 'descriptionModule': {'briefSummary': 'Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. Investigators will determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related HCRU.', 'detailedDescription': 'The most frequently cited danger signs of heart failure (HF) are new onset or worsening of fatigue, dyspnea and edema. In previous research, patients did not recognize worsening HF, due to 3 primary reasons: (1) danger signs were non-specific and misinterpreted as stress, an external force or another comorbidity, (2) danger signs were unrecognized due to the subtle nature of worsening status, or (3) when patients eliminated or minimized activities that prompted danger signs, they interpreted the results as improvement in status. Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. The purposes of this trial are to determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related health care resource utilization. The intervention will be administered during hospitalization, and patients and family members will receive a link to a website and a DVD to review videos as often as desired post-discharge. The primary end-point is 30-day HF-related hospitalization. 732 patients (658 + 10% attrition) with decompensated HF will be enrolled from multiple hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Please answer each question as it applies to you.\n\nSex: 0.\\_\\_\\_\\_\\_\\_ Male 1.\\_\\_\\_\\_\\_\\_ Female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Not referred for cardiac transplantation or ventricular assist device placement during the index hospitalization,\n* Cognitively intact and able to view videos (adequate eyesight and hearing) with correction, if needed,\n* Discharge to home, assisted living facility or to a family member's home and can control dietary sodium and fluids as needed,\n* Willing to participate; which may require up to three (3) follow-up telephone calls post-discharge.\n\nExclusion Criteria:\n\n* Chart documented psychiatric or cognitive conditions that limit ability to understand video content or adhere to self-care recommendations (Alzheimer's condition, dementia, schizophrenia, other neurological history that impairs memory or concentration),\n* Plans to discharge to skilled nursing facility or hospice care,\n* Receiving home hospice or palliative care; or has a medical condition reflecting less than 1 year of survival (cachexia, end stage liver disease or cancer or non-ambulatory New York Heart Association functional class IV HF),\n* Hospitalized but at admission, in New York Heart Association functional class I or II HF\n* Post-cardiac transplantation or ventricular assist device placement,\n* Currently enrolled in another experimental HF research study,\n* Chronic renal failure and receiving chronic hemodialysis therapy for an estimated glomerular filtration rate \\< 15 mL/minute/1.73 m2,\n* A non-traditional form of HF (hypertrophic or restrictive forms of cardiomyopathy, congenital heart disease or Takotsubo cardiomyopathy)."}, 'identificationModule': {'nctId': 'NCT03657459', 'briefTitle': 'Danger Signs in Heart Failure- Effects of Video Education', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Danger Signs of Worsening Heart Failure and Self-Management of Danger Signs: The Effects of Video Education', 'orgStudyIdInfo': {'id': '18-442'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'usual care group', 'description': "Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs"}, {'type': 'ACTIVE_COMPARATOR', 'label': 'video education group', 'description': 'Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign "edema" video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)', 'interventionNames': ['Behavioral: Danger Signs of Heart Failure Videos']}], 'interventions': [{'name': 'Danger Signs of Heart Failure Videos', 'type': 'BEHAVIORAL', 'description': 'Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities) that reflect patient behaviors', 'armGroupLabels': ['video education group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical Center Navicent Health', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '44111', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Fairview Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic main campus', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44125', 'city': 'Garfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Marymount Hospital', 'geoPoint': {'lat': 41.417, 'lon': -81.60596}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Hillcrest Hospital', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '44256', 'city': 'Medina', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Medina Hospital', 'geoPoint': {'lat': 41.13839, 'lon': -81.86375}}, {'zip': '44122', 'city': 'Warrensville Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic South Pointe Hospital', 'geoPoint': {'lat': 41.43505, 'lon': -81.53623}}, {'zip': '15198', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'WellSpan Health', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}], 'overallOfficials': [{'name': 'NANCY M. ALBERT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plans to share individual data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wellflix, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assocaite Chief Nursing Officer-Resaerch and Senior Nurse Scientist', 'investigatorFullName': 'Nancy M. Albert, Ph.D.', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}