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Comprehensive Heart Failure Disease Management Community Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00533013
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : April 5, 2019
Information provided by (Responsible Party):
Ofra Kalter-Leibovici MD, Maccabi Healthcare Services, Israel

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Usual Care Other: Disease Management and Tele-Monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comprehensive Program for Disease Management in Heart Failure Patients in the Community
Study Start Date : August 2007
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Usual care
Management of heart failure is provided by primary practitioners and consultant cardiologists
Other: Usual Care
Management of heart failure is provided by primary practitioners and consultant cardiologists

Experimental: Disease Management
Disease management led by nurse specialists in regional Heart Failure Clinics and a national Call Center. Tele-Monitoring of body weight, pulse rate and blood pressure is performed at participants' homes.
Other: Disease Management and Tele-Monitoring
Management of heart failure is provided by cardiologists at regional heart failure clinics and by nurse practitioners at regional heart failure clinics and a designated call center. Decisions on treatment are guided by designated protocols and information derived for tele-monitoring of blood pressure, body weight and pulse rate.

Primary Outcome Measures :
  1. hospital admissions for heart failure or all-cause mortality [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Health-related Quality of Life; [ Time Frame: 5 years ]
    SF-36 score

  2. Functional status [ Time Frame: 5 years ]
    6-minute walk-test; NYHA classification category

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult patients with NYHA-Stage III-IV heart failure recruited in the community;
  2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00533013

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Maccabi Health Services
Tel-Aviv, Israel
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Haim Silber, M.D. Maccabi Healthcare Services, Israel
Principal Investigator: Ofra Kalter-Leibovici, M.D. Sheba Medical Center
Study Director: Galit Kaufman, RN Sheba Medical Center
Publications of Results:
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Responsible Party: Ofra Kalter-Leibovici MD, Dr. Ofra Kalter-Leibovici, Maccabi Healthcare Services, Israel Identifier: NCT00533013    
Other Study ID Numbers: SHEBA-07-4807-OK-CTIL
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases