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

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

  Show 33 Study Locations
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 April 17, 2014