Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
This study examines whether a nurse monitored management program at the hospital heart failure outpatient clinic can improve quality of life in elderly patients with chronic heart failure, as compared to standard treatment in primary healthcare.
详细描述
Patients 60 years of age or more hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV and systolic dysfunction (left ventricular ejection fraction less than 0.45) are investigated before discharge and than randomized to the nurse monitored management program or to standard care. Examinations are performed at 0, 6, 12, and 18 months, and include clinical signs and symptoms, quality of life, biochemical assessment, echocardiography and drugs used. The study will be completed when all patients have passed the 18 month follow up examination. Quality of life is assessed by the Nottingham health profile.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 60 years of age or older
- •Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV
- •Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography
排除标准
- •An acute myocardial infarction or unstable angina pectoris within the last three months
- •Valvular stenosis
- •Severe concomitant disease
- •Refusal to participate.
结局指标
主要结局
Quality of life
时间窗: 18 months
Nottingham health profile used for quality of life assessment
次要结局
- Hospitalizations(18 months)
- Evaluation of heart failure medication(18 months)
- Mortality(18 months)
研究者
Thomas Kahan
Professor
Karolinska Institutet