Tele-HF: Yale Heart Failure Telemonitoring Study - Full Text View

Sponsors and Collaborators:	Yale University National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00303212

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:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Study of Telemonitoring to Improve Heart Failure Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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 ]

Estimated Enrollment:	1640
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
UC: No Intervention Usual HF guideline-base care
TM: Experimental 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.

Arms

Assigned Interventions

UC: No Intervention

Usual HF guideline-base care

TM: Experimental

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.

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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

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

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

Responsible Party:	Yale School of Medicine ( Harlan Krumholz. MD )
Study ID Numbers:	RO1-HL-080228, 27466
Study First Received:	March 13, 2006
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00303212 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

heart failure
CHF
telemedicine
disease management

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 02, 2009