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
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

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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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014