Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-08 @ 5:35 AM
Study NCT ID:
NCT01360203
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2011-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Better Effectiveness After Transition - Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098465', 'term': 'Remote Patient Monitoring'}], 'ancestors': [{'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2011-05-18', 'studyFirstSubmitQcDate': '2011-05-23', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '180 day rehospitalization rate', 'timeFrame': 'at 180 days post-discharge', 'description': 'Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause'}], 'secondaryOutcomes': [{'measure': '7 day mortality rate', 'timeFrame': 'within 7 days post-discharge', 'description': 'Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.'}, {'measure': 'Change in quality of Life', 'timeFrame': 'as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge', 'description': 'Quality of life scores will be measured using standardized questionnaires, and data captured during enrollment will be compared with data captured during three post-discharge phone calls'}, {'measure': '30 day mortality rate', 'timeFrame': 'at 30 days post-discharge', 'description': 'Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.'}, {'measure': '180 day mortality rate', 'timeFrame': 'at 180 days post-discharge', 'description': 'Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.'}, {'measure': '30 day rehospitalization rate', 'timeFrame': 'at 30 days post-discharge', 'description': 'Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause'}, {'measure': '7 day rehospitalization rate', 'timeFrame': 'within 7 days post-discharge', 'description': 'Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '24725308', 'type': 'BACKGROUND', 'citation': 'Black JT, Romano PS, Sadeghi B, Auerbach AD, Ganiats TG, Greenfield S, Kaplan SH, Ong MK; BEAT-HF Research Group. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial. Trials. 2014 Apr 13;15:124. doi: 10.1186/1745-6215-15-124.'}, {'pmid': '26857383', 'type': 'DERIVED', 'citation': 'Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC; Better Effectiveness After Transition-Heart Failure (BEAT-HF) Research Group. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):310-8. doi: 10.1001/jamainternmed.2015.7712.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of implementing wireless remote monitoring combined with structured telephone monitoring, versus current care, on variation in rehospitalization among older patients hospitalized with heart failure at six medical centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients hospitalized at any of the six medical centers who are being actively treated for heart failure.\n\nExclusion Criteria:\n\n* patients who have previously received a transplant, are being evaluated for a transplant, or who are on the wait list for a transplant,\n* patients who are enrolled or enrolling in hospice, or are expected to expire shortly after discharge,\n* patients with dementia,\n* patients who are admitted from a skilled nursing facility (SNF), or who we anticipate will be discharged to a long term stay in a SNF,\n* patients who do not have a working land line phone or reliable cell service,\n* patients on chronic dialysis,\n* patients who cannot identify a usual source of care (free clinic is acceptable) and who will not be assigned a provider upon discharge,\n* patients with the following cardiovascular conditions: patients with valvular disorders requiring surgical intervention (except for those with incidental valvular disease, who will be included), acute myocardial infarction (except for those with demand ischemia, who will be included), percutaneous coronary intervention\n* patients expected to enroll in hospice or expire after discharge,\n* patients who are unable to use the intervention equipment (e.g., unable to stand on the weight scale), or who are otherwise unable to comply with the intervention'}, 'identificationModule': {'nctId': 'NCT01360203', 'acronym': 'BEAT-HF', 'briefTitle': 'Better Effectiveness After Transition - Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Variations in Care: Comparing Heart Failure Care Transition Intervention Effects', 'orgStudyIdInfo': {'id': 'R01HS019311', 'link': 'https://reporter.nih.gov/quickSearch/R01HS019311', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Current Care', 'description': 'Patients will receive the current care provided to heart failure patients at each of the study sites'}, {'type': 'EXPERIMENTAL', 'label': 'Care Transition Intervention', 'description': 'Care transition intervention beginning prior to discharge and through six months post-discharge.', 'interventionNames': ['Other: Structured Telephone / Remote Outpatient Monitoring']}], 'interventions': [{'name': 'Structured Telephone / Remote Outpatient Monitoring', 'type': 'OTHER', 'otherNames': ['Care Transition Intervention', 'Care Transitions Intervention', 'Structured Telephone Monitoring', 'Remote Monitoring'], 'description': 'During their hospitalization, patients will receive education on their condition and will be taught to use a wireless remote monitoring device that they will use from home on a daily basis for six months following hospital discharge. Patients will receive structured telephone phone calls from a centralized call center nurse at least once a week for the first month post-discharge, and monthly for the remainder of the six month study period. Patients may receive additional calls depending upon the information gathered during the scheduled call center phone calls and/or their health status as ascertained by the data (weight, heart rate, blood pressure, answers to general health and heart failure-related questions) transmitted daily by the wireless remote monitoring device.', 'armGroupLabels': ['Care Transition Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Michael K Ong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, {'name': 'University of California, Davis', 'class': 'OTHER'}, {'name': 'University of California, Irvine', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michael Ong', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}