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临床试验/NCT01696890
NCT01696890终止2 期

Integration of Follow-up by First and Second Line Practitioners Facilitated by Telemonitoring Versus Stand-alone Telemonitoring in Patients With Severe Heart Failure

Jessa Hospital7 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
终止
发起方
入组人数
50
试验地点
7
主要终点
number of rehospitalizations

研究概览

简要总结

The aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach.

详细描述

The incidence of acute decompensated heart failure is increasing. Patients with severe heart failure are rehospitalised for decompensation several times each year, increasing the cost for health care. In these cases of recurrent decompensation, the medical intervention in hospital is often limited to increasing the dosage of diuretics or vasodilators until the patient reaches a compensated state. After discharge, a readmission can be expected within a few months. A multidisciplinary approach by primary physician, heart failure nurse, rehabilitation team and cardiologist has been shown to decrease rehospitalisation rate and increase quality of life.

Very recently, our study group showed that an intense collaboration between first line practitioner and heart failure clinic, facilitated by the use of telemonitoring, can reduce mortality and hospitalisation rate. This study was a RIZIV sponsored trial of 6 months follow-up in patients with chronic heart failure. However, a large randomised multicentre trial investigating the use of telemonitoring in a population of heart failure (NYHA II-III) patients did not find any difference between telemonitoring and usual care (Chaudry et al NEJM 2010). In contradiction with this study, a Cochrane meta-analysis (Ingliss 2010) in more than 5000 patients confirmed our finding with a reduction in mortality and morbidity. The question therefore remains which factors are responsible for success or failure of the use of telemonitoring. Based on our previous experience, the approach of close monitoring by telemonitoring, with first line intervention by the patient's general practitioner (GP) and supervision by the heart failure clinic, might be the critical success factor.

Therefore, the aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach.

研究设计

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

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients hospitalized for decompensation of systolic heart failure
  • •LVEF < 40% during hospitalization.

排除标准

  • •reversible forms of acute heart failure (acute ischemia, myocarditis,..)
  • •heart failure due to severe aortic stenosis
  • •participation in cardiac rehabilitation after discharge
  • •previous or actual residency in a nursing home
  • •creatinine clearance <15 ml/min
  • •planned dialysis in the next 6 months
  • •planned biventricular pacemaker or cardiac surgery
  • •life expectancy of less than 1 year due to other diseases
  • •severe obstructive pulmonary disease (Gold III)
  • •significant mental or cognitive problems interfering with the daily measurements or intake of medication.

研究组 & 干预措施

integrated care

Active Comparator

telemonitoring-assisted follow-up with intensive collaboration between general practitioner and specialized Heart failure clinic.

干预措施: integrated follow-up (Device)

standard care

Active Comparator

telemonitoring- assisted follow-up with usual care by general practitioner, without supervision of heart failure clinic

干预措施: standard care (Device)

结局指标

主要结局

number of rehospitalizations

时间窗: 6 months

overall mortality

时间窗: 6 months

time investment by HF nurses

时间窗: 6 months

次要结局

  • quality of life(6 months)
  • appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2)(6 months)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Dendale

Prof Dr

Jessa Hospital

研究点 (7)

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