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临床试验/NCT01454817
NCT01454817已完成不适用

A Study of Symptoms and Quality of Life in Patients With ICDs and Their Caregivers

Icahn School of Medicine at Mount Sinai11 个研究点 分布在 1 个国家目标入组 562 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
562
试验地点
11
主要终点
Psychological Symptoms

研究概览

简要总结

The purpose of this study is to better understand symptoms and quality of life in patients with heart disease and implantable defibrillators (ICDs).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, 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

入选标准

  • Patient has an ICD
  • Age > 18
  • Fluent in English
  • Consistent and reliable access to a phone.
  • Caregivers of Patients:
  • Age > 18
  • Fluent in English
  • Consistent and reliable access to a phone

排除标准

  • Not having an ICD

结局指标

主要结局

Psychological Symptoms

时间窗: every 3 months plus after hospitalizations for an average of 1 year

Psychological symptoms of anxiety and depression

Physical Symptoms

时间窗: every 3 months plus after hospitalizations for an average of 1 year

physical symptoms of pain, shortness of breath, depression, anxiety

次要结局

  • Quality of Life(every 3 months plus after hospitalizations for an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

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