NCT01454817已完成不适用
A Study of Symptoms and Quality of Life in Patients With ICDs and Their Caregivers
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
- 562
- 试验地点
- 6
- 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
- 否
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
研究组 & 干预措施
Patients with ICDs
Other
干预措施: Quality of life (Behavioral)
Caregivers of Patients with ICDs
Other
干预措施: Quality of life (Behavioral)
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
研究点 (6)
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