Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-01-25 @ 7:09 AM
Study NCT ID:
NCT00303212
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2006-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tele-HF: Yale Heart Failure Telemonitoring Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2006-03-13', 'studyFirstSubmitQcDate': '2006-03-13', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of all-cause hospital readmission or death during the 6-month follow-up period.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Rate of all-cause hospital readmissions', 'timeFrame': '6 months'}, {'measure': 'Number of office visits with clinician receiving information from the telemonitoring system', 'timeFrame': '6 months'}, {'measure': 'Survival after index hospitalization', 'timeFrame': '6 months'}, {'measure': 'Cost of inpatient medical care', 'timeFrame': '6 months'}, {'measure': 'Health status', 'timeFrame': '6 months'}, {'measure': 'Patient satisfaction with care', 'timeFrame': '6 months'}, {'measure': "Patients' self-management of heart failure", 'timeFrame': '6 months'}, {'measure': 'Post index discharge hospital days', 'timeFrame': '6 months'}, {'measure': 'Post index discharge hospital days/follow up days alive', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['heart failure', 'CHF', 'telemedicine', 'disease management'], 'conditions': ['Congestive Heart Failure']}, 'referencesModule': {'references': [{'pmid': '29237746', 'type': 'DERIVED', 'citation': 'Jayaram NM, Khariton Y, Krumholz HM, Chaudhry SI, Mattera J, Tang F, Herrin J, Hodshon B, Spertus JA. Impact of Telemonitoring on Health Status. Circ Cardiovasc Qual Outcomes. 2017 Dec;10(12):e004148. doi: 10.1161/CIRCOUTCOMES.117.004148.'}, {'pmid': '28420352', 'type': 'DERIVED', 'citation': 'Steventon A, Chaudhry SI, Lin Z, Mattera JA, Krumholz HM. Assessing the reliability of self-reported weight for the management of heart failure: application of fraud detection methods to a randomised trial of telemonitoring. BMC Med Inform Decis Mak. 2017 Apr 18;17(1):43. doi: 10.1186/s12911-017-0426-4.'}, {'pmid': '28263938', 'type': 'DERIVED', 'citation': 'Mortazavi BJ, Downing NS, Bucholz EM, Dharmarajan K, Manhapra A, Li SX, Negahban SN, Krumholz HM. Analysis of Machine Learning Techniques for Heart Failure Readmissions. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):629-640. doi: 10.1161/CIRCOUTCOMES.116.003039. Epub 2016 Nov 8.'}, {'pmid': '26656140', 'type': 'DERIVED', 'citation': 'Krumholz HM, Chaudhry SI, Spertus JA, Mattera JA, Hodshon B, Herrin J. Do Non-Clinical Factors Improve Prediction of Readmission Risk?: Results From the Tele-HF Study. JACC Heart Fail. 2016 Jan;4(1):12-20. doi: 10.1016/j.jchf.2015.07.017. Epub 2015 Dec 2.'}, {'pmid': '26160368', 'type': 'DERIVED', 'citation': 'Qian F, Parzynski CS, Chaudhry SI, Hannan EL, Shaw BA, Spertus JA, Krumholz HM. Racial Differences in Heart Failure Outcomes: Evidence From the Tele-HF Trial (Telemonitoring to Improve Heart Failure Outcomes). JACC Heart Fail. 2015 Jul;3(7):531-538. doi: 10.1016/j.jchf.2015.03.005.'}, {'pmid': '25074375', 'type': 'DERIVED', 'citation': 'Bikdeli B, Wayda B, Bao H, Ross JS, Xu X, Chaudhry SI, Spertus JA, Bernheim SM, Lindenauer PK, Krumholz HM. Place of residence and outcomes of patients with heart failure: analysis from the telemonitoring to improve heart failure outcomes trial. Circ Cardiovasc Qual Outcomes. 2014 Sep;7(5):749-56. doi: 10.1161/CIRCOUTCOMES.113.000911. Epub 2014 Jul 29.'}, {'pmid': '21080835', 'type': 'DERIVED', 'citation': 'Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the effectiveness of telemonitoring compared with usual guideline-based care in preventing hospitalization for heart failure patients.', 'detailedDescription': 'Heart failure (HF) is a common, costly condition characterized by recurrent periods of clinical decompensation that often lead to repeated hospitalizations (1, 2). Despite advances in the care of patients with HF, population-based outcomes such as mortality and hospitalization rates have not improved substantially over the past decade (3). Episodic, infrequent, outpatient visits are the only usual opportunities for clinicians to detect and treat early signs of HF decompensation; this constitutes a major gap in the current medical model. Moreover, opportunities for patients to take an active role in managing their own conditions occur infrequently. Disease management has emerged as a possible solution to the need for better patient surveillance and engagement. It typically involves multidisciplinary efforts to improve the quality and efficiency of care for patients with chronic conditions, with interventions designed to foster adherence of clinicians to scientific guidelines and patients to treatment plans. However, traditional disease-management programs are generally resource-intensive (often relying on nurse case management), difficult to scale for a large population, and inefficient in providing daily patient monitoring.\n\nTelemonitoring, which bridges clinicians and patients with communication technology, holds promise for closing the gap in HF care (4). This technology has the potential for standardized, widespread implementation (and long-term maintenance) in the near future because it can be easily applied to large patient populations and integrated into the current medical care system. Supporting this potential, preliminary evaluations have suggested that telemonitoring is feasible across a broad spectrum of typical HF patients, relatively inexpensive on a per-patient basis, and highly effective in improving health outcomes. Thus, this approach is ready for rigorous evaluation.\n\nAccordingly, we propose an office-based, multicenter, randomized controlled trial (Tele-HF study) to determine the effectiveness of a telemonitoring strategy in decreasing hospital readmissions and death in patients with HF. Many HF patients experience deterioration in their health status and an increase in weight and symptoms over a period of days and weeks before ultimately presenting to medical attention and requiring hospitalization. Our premise is that a frequent monitoring system can alert clinicians to the early signs and symptoms of decompensation, providing the opportunity for intervention before the patient becomes severely ill and requires hospitalization. Moreover, such a system can engage patients in their care and provide instruction about beneficial self-care strategies. This intervention is not intended to substitute for communication relating to acute care or acute, sudden changes in health status. In these cases, patients are instructed to make direct and immediate contact with their doctor or hospital.\n\nWe will use the Pharos Tel-AssuranceTM, an in-home communication system that allows patients to transmit information to their clinicians and provides education to enable patients to actively participate in managing their condition. The system uses conventional telephone lines and does not require the patient to have Internet access. Patients are asked a pre-programmed series of questions and the system automatically uploads the responses to a secure data center. A clinician in each practice can then log on to a secure Internet site using a Web browser to review the patients\' responses. The system thus serves as an interface between patients at home and their clinicians, facilitating monitoring of chronic conditions and patient education. While many vendors have potential tools to implement this study, we chose to use Pharos Tel-AssuranceTM because it is simple to use, does not require any equipment in patients\' homes and substantial preliminary data suggest high patient and clinician satisfaction with its use. The investigators have no financial interest in this company.\n\nPrimary Aim Our primary aim is to determine whether telemonitoring by community-based cardiology office practices reduces the risk of hospital readmission (for any cause) or death after an initial "index hospitalization" for HF. We hypothesize that, among patients recently discharged after a hospitalization for HF, telemonitoring will decrease the rate of rehospitalization or death over 6 months by at least 15% (relative risk reduction). This would yield an absolute risk reduction of 7.5%, so that 1 major adverse event would be averted for every 13 patients.\n\nWe have chosen all-cause readmission as part of our primary outcome because poorly controlled HF can result in admissions for a variety of reasons, as the patient becomes weak and susceptible to falls, mental status changes, renal dysfunction, and other debilitating conditions that can result in hospitalization. In addition, from a societal and health system perspective, the overall risk of readmission is more important than disease-specific readmission. Moreover, prior studies suggest that telemonitoring can reduce this outcome.\n\nSecondary Aims\n\nIn our secondary aims we will determine whether telemonitoring will:\n\n1. Reduce the rate of all-cause hospital readmission\n2. Reduce the rate of hospital readmission for HF\n3. Reduce the total number of all-cause and HF-specific hospital readmissions\n4. Increase office visits with the clinician receiving information from the telemonitoring system\n5. Improve survival after index hospitalization\n6. Reduce the cost of inpatient medical care\n7. Improve health status\n8. Improve patient satisfaction with care\n9. Improve patients\' self-management of HF\n\nSub-Group Analyses\n\nThe following sub-group analyses will be conducted:\n\n1. Age\n2. Sex\n3. Race\n4. HFPEF vs depressed EF\n5. Education\n6. Insurance status\n7. Self-reported access to care\n8. Baseline self-efficacy and self-care\n9. Socioeconomic Status\n10. Site characteristics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older\n* hospitalized for heart failure within the past 30 days\n* access to telephone line\n\nExclusion Criteria:\n\n* not expected to survive 6 months due to irreversible, life-threatening condition\n* has or scheduled for cardiac transplant or LVAD\n* scheduled for CABG or PCI within 90 days\n* severe valvular disease\n* Folstein MMSE score less than 20\n* resident of a nursing home\n* currently a prisoner\n* does not speak English or Spanish'}, 'identificationModule': {'nctId': 'NCT00303212', 'briefTitle': 'Tele-HF: Yale Heart Failure Telemonitoring Study', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'A Study of Telemonitoring to Improve Heart Failure Outcomes', 'orgStudyIdInfo': {'id': '0502027466'}, 'secondaryIdInfos': [{'id': 'R01HL080228', 'link': 'https://reporter.nih.gov/quickSearch/R01HL080228', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'UC', 'description': 'Usual HF guideline-base care'}, {'type': 'EXPERIMENTAL', 'label': 'TM', 'description': 'Telemonitoring group plus usual guideline-based HF care', 'interventionNames': ['Other: Telemonitoring']}], 'interventions': [{'name': 'Telemonitoring', 'type': 'OTHER', 'otherNames': ['Tel-Assurance'], 'description': "Participants in the intervention group are instructed to make a daily toll-free call to an automated telemonitoring system being provided by Pharos Innovations® (Chicago, IL) for 6 months.On each call patients hear a pre-recorded voice that goes through a series of questions about symptoms and the patient's daily weight. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians at each practice site.", 'armGroupLabels': ['TM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cardiology Associates', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Harbor Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Department of Cardiology at Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06437', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Cardiology Associates of New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20059', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrated Care / Cardiovascular Consultants of South Florida', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Hospital Research Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30310', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Morehouse School of Medicine/Cardiology', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "The Queen's Medical Center", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Heart Physicians', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52245', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa City Heart Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '70363', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Chabert Medical Center', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Heart Clinic of Louisiana', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Cardiology Associates, LLC', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Truman Medical Center/Cardiology', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Hospital / Mid-America Heart Institute", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63122', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Cardiology Diagnostics', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Health System Cardiology', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '07503', 'city': 'Paterson', 'state': 'New Jersey', 'country': 'United States', 'facility': "St. Joseph's Regional Medical Center / Cardiology Associates", 'geoPoint': {'lat': 40.91677, 'lon': -74.17181}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University/Cardiology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center, Heart & Vascular Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Dayton Heart Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '70363', 'city': 'Westerly', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Cardiology Specialists, Ltd.', 'geoPoint': {'lat': 41.3776, 'lon': -71.82729}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Cardiology Consultants, Ltd.', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Harlan M. Krumholz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}, {'name': 'Sarwat I Chaudhry, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yale University'}, {'name': 'Jennifer Mattera, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Harlan Krumholz. MD', 'oldOrganization': 'Yale School of Medicine'}}}}