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Comprehensive Heart Failure Disease Management Community Program

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ClinicalTrials.gov Identifier: NCT00533013
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : April 26, 2013
Sponsor:
Collaborator:
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
Ofra Kalter-Leibovici MD, Sheba Medical Center

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.

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
U.S. FDA Resources

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. Quality of life; [ Time Frame: 5 years ]
  2. Functional status [ Time Frame: 5 years ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00533013


Locations
Israel
Maccabi Health Services
Tel-Aviv, Israel
Sponsors and Collaborators
Ofra Kalter-Leibovici MD
Maccabi Healthcare Services, Israel
Investigators
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ofra Kalter-Leibovici MD, Dr. Ofra Kalter-Leibovici, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00533013     History of Changes
Other Study ID Numbers: SHEBA-07-4807-OK-CTIL
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases