Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,202
- 试验地点
- 2
- 主要终点
- Hospital admission for acute exacerbation of COPD or all-cause mortality
研究概览
简要总结
The purpose of this study is to determine whether comprehensive disease management program combined with best care recommended in clinical guidelines, is more effective than best care alone in patients with advanced chronic obstructive pulmonary disease (COPD).
详细描述
The study objective is to evaluate the effectiveness of a comprehensive program among patients with advanced COPD, implemented by a multi-disciplinary team. The program consists of best care recommended in clinical guidelines, combined with disease management, compared to best care only.
The program will include designated COPD centers operated by multi-disciplinary teams (pulmonologists, nurse practitioners, physiotherapists, social workers and dietitians). Disease management will be provided in these centers by qualified designated nurses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older
- •Advanced COPD
排除标准
- •Permanent tracheostomy
- •Heart failure with significant left-ventricular dysfunction
- •Severe other chronic disease
- •Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate
- •No telephone or permanent address
- •Refusal to use telemonitoring equipment
- •Participation in another clinical trial
结局指标
主要结局
Hospital admission for acute exacerbation of COPD or all-cause mortality
时间窗: Within 2 to 5 years after randomization
次要结局
- Depression(Within 2 to 5 years after randomization)
- Functional capacity(Within 2 to 5 years after randomization)
- Spirometry parameters(Within 2 to 5 years after randomization)
- Total days of hospitalization for acute exacerbations of COPD(Within 2 to 5 years after randomization)
- Total number of acute exacerbations of COPD(Within 2 to 5 years after randomization)
- Quality of life(Within 2 to 5 years after randomization)
研究者
Ofra Kalter-Leibovici MD
Director of the Unit of Cardiovascular Epidemiology, Gertner Institute.
Sheba Medical Center