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临床试验/NCT00502255
NCT00502255已完成不适用

Telemonitoring in Patients With Heart Failure

Maastricht University Medical Center4 个研究点 分布在 1 个国家目标入组 382 人开始时间: 2007年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
382
试验地点
4
主要终点
To what extent does the use of Health Buddy result in a decrease in hospital admissions?

研究概览

简要总结

The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Patients > 18 years
  • Patients with heart failure NYHA classification II-III-IV
  • Patient experienced a period of fluid retention
  • Patient is treated by a cardiologist
  • Patient is followed-up by a heart failure nurse
  • Adequate knowledge of the Dutch language
  • Patient has an active telephone connection, preferably analogue
  • Patient is mental competent
  • Patient has the disposal of a balance

排除标准

  • Patients suffering from COPD, Gold classification 3 or 4
  • Patient is a dialysis patient
  • Patient has a visual restriction to read the dialogues on the Health Buddy
  • Patient is hard of hearing or deaf
  • Patient suffers from a lethal sickness with a prognosis < 1 year
  • Patient participates in another trial
  • Patient needs a hospital admission on short time, i.e., < 3 months
  • Patient used the Health Buddy in an earlier stage
  • Patient is an illiterate person.

结局指标

主要结局

To what extent does the use of Health Buddy result in a decrease in hospital admissions?

时间窗: one year

To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?

时间窗: one year

To what extent is Health Buddy® more cost-effective than usual care?

时间窗: one year

次要结局

  • What is the effect of Health Buddy® in patients with heart failure in regard to drug consumption and therapy compliance and level of knowledge, and quality of life?(one year)
  • To what extent is it - based on patients' characteristics - possible to identify patient with benefits?(one year)

研究者

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

Josiane Boyne

RN,MA

Maastricht University Medical Center

研究点 (4)

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