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临床试验/NCT00533013
NCT00533013已完成不适用

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

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 1,360 人开始时间: 2007年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,360
试验地点
1
主要终点
hospital admissions for heart failure or all-cause mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Disease Management

Experimental

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.

干预措施: Disease Management and Tele-Monitoring (Other)

Usual care

Active Comparator

Management of heart failure is provided by primary practitioners and consultant cardiologists

干预措施: Usual Care (Other)

结局指标

主要结局

hospital admissions for heart failure or all-cause mortality

时间窗: 5 years

次要结局

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

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ofra Kalter-Leibovici MD

Dr. Ofra Kalter-Leibovici

Maccabi Healthcare Services, Israel

研究点 (1)

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