跳至主要内容
临床试验/NCT00753259
NCT00753259已完成不适用

The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 712 人开始时间: 2006年6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
712
试验地点
2
主要终点
Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes.

研究概览

简要总结

  • Randomized controlled trial comparing specialized AF Clinic with 'care as usual'
  • Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists.

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
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
否

入选标准

  • •Newly diagnosed atrial fibrillation

排除标准

  • •Age < 18 years
  • •unwillingness to participate

研究组 & 干预措施

AF Clinic

Experimental

干预措施: AF Clinic (Other)

Care as Usual

Active Comparator

干预措施: Care as Usual (Other)

结局指标

主要结局

Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes.

时间窗: minimum of 1 year

次要结局

  • All cause mortality, all cause hospitalizations, Treatment (benchmarking) in accordance to the 2006 AHA/ACC/ESC guidelines in AF, quality of life, patient satisfaction, anxiety, depression, compliance and cost effectiveness.(minimum of 1 year)

研究者

申办方类型
Other

研究点 (2)

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