Comprehensive Heart Failure Disease Management Community Program
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | September 20, 2007 | ||||||||||||
| Last Updated Date | April 25, 2013 | ||||||||||||
| Start Date ICMJE | August 2007 | ||||||||||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
hospital admissions for heart failure or all-cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
hospital admissions for heart failure or all-cause mortality [ Time Frame: One year ] | ||||||||||||
| Change History | Complete list of historical versions of study NCT00533013 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Comprehensive Heart Failure Disease Management Community Program | ||||||||||||
| Official Title ICMJE | Comprehensive Program for Disease Management in Heart Failure Patients in the Community | ||||||||||||
| 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. |
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| 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 ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Heart Failure | ||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 1360 | ||||||||||||
| Completion Date | July 2012 | ||||||||||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Israel | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00533013 | ||||||||||||
| Other Study ID Numbers ICMJE | SHEBA-07-4807-OK-CTIL | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Ofra Kalter-Leibovici MD, Sheba Medical Center | ||||||||||||
| Study Sponsor ICMJE | Ofra Kalter-Leibovici MD | ||||||||||||
| Collaborators ICMJE | Maccabi Healthcare Services, Israel | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Sheba Medical Center | ||||||||||||
| Verification Date | April 2013 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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