Tele-HF: Yale Heart Failure Telemonitoring Study
A Study of Telemonitoring to Improve Heart Failure Outcomes
2 other identifiers
interventional
1,660
1 country
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2006
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 13, 2006
CompletedFirst Posted
Study publicly available on registry
March 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedMarch 30, 2020
September 1, 2010
3.8 years
March 13, 2006
March 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of all-cause hospital readmission or death during the 6-month follow-up period.
6 months
Secondary Outcomes (9)
Rate of all-cause hospital readmissions
6 months
Number of office visits with clinician receiving information from the telemonitoring system
6 months
Survival after index hospitalization
6 months
Cost of inpatient medical care
6 months
Health status
6 months
- +4 more secondary outcomes
Study Arms (2)
UC
NO INTERVENTIONUsual HF guideline-base care
TM
EXPERIMENTALTelemonitoring group plus usual guideline-based HF care
Interventions
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.
Eligibility Criteria
You may qualify if:
- age 18 years or older
- hospitalized for heart failure within the past 30 days
- access to telephone line
You may not qualify if:
- not expected to survive 6 months due to irreversible, life-threatening condition
- has or scheduled for cardiac transplant or LVAD
- scheduled for CABG or PCI within 90 days
- severe valvular disease
- Folstein MMSE score less than 20
- resident of a nursing home
- currently a prisoner
- does not speak English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institutes of Health (NIH)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (33)
Cardiology Associates
Mobile, Alabama, 36608, United States
UC Irvine Medical Center
Orange, California, 92868, United States
UCLA Harbor Medical Center
Torrance, California, 90502, United States
Department of Cardiology at Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Cardiology Associates of New Haven
New Haven, Connecticut, 06437, United States
Howard University Hospital
Washington D.C., District of Columbia, 20059, United States
Integrated Care / Cardiovascular Consultants of South Florida
Tamarac, Florida, 33321, United States
Piedmont Hospital Research Institute
Atlanta, Georgia, 30309, United States
Morehouse School of Medicine/Cardiology
Atlanta, Georgia, 30310, United States
Emory University
Atlanta, Georgia, 30322, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana Heart Physicians
Indianapolis, Indiana, 46237, United States
Iowa City Heart Center
Iowa City, Iowa, 52245, United States
Chabert Medical Center
Houma, Louisiana, 70363, United States
Heart Clinic of Louisiana
Marrero, Louisiana, 70072, United States
Cardiology Associates, LLC
Tupelo, Mississippi, 38801, United States
Truman Medical Center/Cardiology
Kansas City, Missouri, 64108, United States
St. Luke's Hospital / Mid-America Heart Institute
Kansas City, Missouri, 64111, United States
Washington University
St Louis, Missouri, 63110, United States
Cardiology Diagnostics
St Louis, Missouri, 63122, United States
Cooper Health System Cardiology
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
St. Joseph's Regional Medical Center / Cardiology Associates
Paterson, New Jersey, 07503, United States
New York University/Cardiology
New York, New York, 10016, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
MetroHealth Medical Center, Heart & Vascular Center
Cleveland, Ohio, 44109, United States
The Dayton Heart Center
Dayton, Ohio, 45414, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
Cardiology Specialists, Ltd.
Westerly, Rhode Island, 70363, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Sentara Cardiology Consultants, Ltd.
Norfolk, Virginia, 23507, United States
Related Publications (7)
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: 29237746DERIVEDSteventon 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: 28420352DERIVEDMortazavi 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: 28263938DERIVEDKrumholz 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: 26656140DERIVEDQian 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: 26160368DERIVEDBikdeli 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: 25074375DERIVEDChaudhry 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.
PMID: 21080835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harlan M. Krumholz, M.D.
Yale University
- STUDY DIRECTOR
Sarwat I Chaudhry, MD
Yale University
- STUDY DIRECTOR
Jennifer Mattera, MPH
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 13, 2006
First Posted
March 15, 2006
Study Start
March 1, 2006
Primary Completion
January 1, 2010
Study Completion
July 1, 2010
Last Updated
March 30, 2020
Record last verified: 2010-09