An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 346
- 试验地点
- 67
- 主要终点
- Number of unscheduled hospital days
研究概览
简要总结
The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.
By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.
详细描述
Primary objective: To evaluate a strategy of Chronic Obstructive Pulmonary Disease (COPD) management to reduce the number of hospital days in patients with severe Gold III/IV COPD: a Home-Based COPD Management Program versus usual patient education and follow-up.
Secondary objectives:
- To assess the clinical outcome and the health-related quality of life,
- To assess safety,
- To evaluate medico-economic impact.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Gold III/IV COPD
- •Current or ex-smoker with a smoking history ≥ 10 pack-years
- •At least one COPD exacerbation leading to hospitalization in the year before selection.
排除标准
- •LTOT for another reason than COPD
- •Severe concomitant disorder associated with a limited probability of survival (< 6 months)
- •Tracheostomy
- •Long term oral corticosteroids therapy
结局指标
主要结局
Number of unscheduled hospital days
时间窗: up to 12 months
次要结局
- Safety parameters(up to 12 months)
- Medico-economic data(up to 12 months)
- Health related quality of life(up to 12 months)
- Use of health care services(up to 12 months)
- Compliance to oxygen therapy(up to 12 months)
- Number of hospital days due to severe COPD exacerbation(up to 12 months)