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Clinical Trials/NCT00533013
NCT00533013
Completed
Not Applicable

Comprehensive Program for Disease Management in Heart Failure Patients in the Community

Sheba Medical Center1 site in 1 country1,360 target enrollmentAugust 2007
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Sheba Medical Center
Enrollment
1360
Locations
1
Primary Endpoint
hospital admissions for heart failure or all-cause mortality
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to determine whether a nurse-led, comprehensive disease management program is effective in reducing recurrent hospital admissions and deaths in community dwelling patients with moderate to severe heart failure.

Detailed Description

Heart failure remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Heart failure is associated with increasing costs for healthcare, mainly for recurrent hospital admissions. Disease management programs aimed to improve patients outcome while containing healthcare costs,were employed in heart failure patients with varying results. Such programs contain various components, including patient education and empowerment, monitoring patients' adherence to therapy, telemonitoring of vital parameters, etc. Designated heart failure clinics were also employed in care given to these patients.

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
July 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ofra Kalter-Leibovici MD

Dr. Ofra Kalter-Leibovici

Maccabi Healthcare Services, Israel

Eligibility Criteria

Inclusion Criteria

  • Adult patients with NYHA-Stage III-IV heart failure recruited in the community;
  • Adult patients with NYHA-Stage II-IV heart failure recruited after hospital admission for decompensated heart failure

Exclusion Criteria

  • Other severe disease (e.g. end stage renal disease, metastatic cancer); bedridden or severely compromised functional status due to other diseases; drug or alcohol abuse; Severe cognitive impairment; People unconnected to telephone

Outcomes

Primary Outcomes

hospital admissions for heart failure or all-cause mortality

Time Frame: 5 years

Secondary Outcomes

  • Health-related Quality of Life;(5 years)
  • Functional status(5 years)

Study Sites (1)

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