Tele-HF: Yale Heart Failure Telemonitoring Study

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00303212
First received: March 13, 2006
Last updated: September 16, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Other: Telemonitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study of Telemonitoring to Improve Heart Failure Outcomes

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Rate of all-cause hospital readmission or death during the 6-month follow-up period. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of all-cause hospital readmissions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of office visits with clinician receiving information from the telemonitoring system [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Survival after index hospitalization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cost of inpatient medical care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient satisfaction with care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patients' self-management of heart failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Post index discharge hospital days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Post index discharge hospital days/follow up days alive [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1660
Study Start Date: March 2006
Study Completion Date: July 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: UC
Usual HF guideline-base care
Experimental: TM
Telemonitoring group plus usual guideline-based HF care
Other: Telemonitoring
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.
Other Name: Tel-Assurance

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 years or older
  • hospitalized for heart failure within the past 30 days
  • access to telephone line

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303212

  Hide Study Locations
Locations
United States, Alabama
Cardiology Associates
Mobile, Alabama, United States, 36608
United States, California
UC Irvine Medical Center
Orange, California, United States, 92868
UCLA Harbor Medical Center
Torrance, California, United States, 90502
United States, Connecticut
Department of Cardiology at Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Cardiology Associates of New Haven
New Haven, Connecticut, United States, 06437
United States, District of Columbia
Howard University Hospital
Washington, DC, District of Columbia, United States, 20059
United States, Florida
Integrated Care / Cardiovascular Consultants of South Florida
Tamarac, Florida, United States, 33321
United States, Georgia
Morehouse School of Medicine/Cardiology
Atlanta, Georgia, United States, 30310
Emory University
Atlanta, Georgia, United States, 30322
Piedmont Hospital Research Institute
Atlanta, Georgia, United States, 30309
United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana Heart Physicians
Indianapolis, Indiana, United States, 46237
United States, Iowa
Iowa City Heart Center
Iowa City, Iowa, United States, 52245
United States, Louisiana
Chabert Medical Center
Houma, Louisiana, United States, 70363
Heart Clinic of Louisiana
Marrero, Louisiana, United States, 70072
United States, Mississippi
Cardiology Associates, LLC
Tupelo, Mississippi, United States, 38801
United States, Missouri
Truman Medical Center/Cardiology
Kansas City, Missouri, United States, 64108
St. Luke's Hospital / Mid-America Heart Institute
Kansas City, Missouri, United States, 64111
Cardiology Diagnostics
St. Louis, Missouri, United States, 63122
Washington University
St. Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Health System Cardiology
Camden, New Jersey, United States, 08103
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
St. Joseph's Regional Medical Center / Cardiology Associates
Paterson, New Jersey, United States, 07503
United States, New York
New York University/Cardiology
New York, New York, United States, 10016
United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
MetroHealth Medical Center, Heart & Vascular Center
Cleveland, Ohio, United States, 44109
The Dayton Heart Center
Dayton, Ohio, United States, 45414
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
United States, Rhode Island
Cardiology Specialists, Ltd.
Westerly, Rhode Island, United States, 70363
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Virginia
Sentara Cardiology Consultants, Ltd.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Harlan M. Krumholz, M.D. Yale University
Study Director: Sarwat I Chaudhry, MD Yale University
Study Director: Jennifer Mattera, MPH Yale University
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harlan Krumholz. MD, Yale School of Medicine
ClinicalTrials.gov Identifier: NCT00303212     History of Changes
Other Study ID Numbers: RO1-HL-080228, 27466
Study First Received: March 13, 2006
Last Updated: September 16, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
heart failure
CHF
telemedicine
disease management

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 15, 2014