NCT02258646已完成不适用
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
University Hospital of North Norway6 个研究点 分布在 3 个国家目标入组 120 人开始时间: 2014年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Combined number of hospitalizations and emergency department presentations
研究概览
简要总结
This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD
- •At least one COPD-related hospitalization or COPD-related emergency department presentation in the previous 12 months to enrollment
- •Capable to provide signed written informed consent
排除标准
- •Attendance to a rehabilitation program in the previous 6 months of enrollment
- •Participation in another study that may have an impact on the outcome of this study
- •Deemed by the health care team to be physically uncapable to perform the study procedures
- •Presence of comorbidities wich might prevent the patient from safely undertake an exercise program at home
- •Home environment not suitable for installation and use of rehabilitation and monitoring equipment (e.g. physical space, Wi-FI Internet or mobile Internet via 4G)
研究组 & 干预措施
Telerehabilitation
Experimental
Exercise training at home, telemonitoring, and education/self-management
干预措施: Telemonitoring and education/self-management (Behavioral)
Telerehabilitation
Experimental
Exercise training at home, telemonitoring, and education/self-management
干预措施: Exercise training at home (Behavioral)
Unsupervised exercise training at home
Experimental
Unsupervised exercise training at home
干预措施: Exercise training at home (Behavioral)
Usual care
No Intervention
Usual care
结局指标
主要结局
Combined number of hospitalizations and emergency department presentations
时间窗: Two years
次要结局
- Change from baseline in EQ-5D at 2 years(Two years)
- Change from baseline in EQ-5D at 1 year(One year)
- Change from baseline in physical activity at 1 year(One year)
- Change from baseline in physical activity at 2 years(Two years)
- Hospitalizations at 1 year(One year)
- Change from baseline in 6- minute walking distance at 2 years(Two years)
- Cost-effectiveness(Two years)
- Change from baseline in Generalized Self-Efficacy Scale at 2 years(Two years)
- Change from baseline in Hospital Anxiety and Depression Scale at 1 year(One Year)
- Change from baseline in Generalized Self-Efficacy Scale at 6 months(Six months)
- Emergency department presentations at 1 year(One year)
- Hospitalizations(Two years)
- Mortality(Two years)
- Change from baseline in COPD Assessment Test at 1 year(One year)
- Change from baseline in physical activity at 6 months(Six months)
- Patient Global Impression of Change after 2 years(Two years)
- Emergency department presentations(Two years)
- Change from baseline in EQ-5D at 6 months(Six months)
- Change from baseline in Generalized Self-Efficacy Scale at 1 year(One year)
- Change from baseline in 6- minute walking distance at 6 months(Six months)
- Change from baseline in 6- minute walking distance at 1 year(One year)
- Mortality at 1 year(One year)
- Change from baseline in Hospital Anxiety and Depression Scale at 6 months(Six months)
- Change from baseline in Hospital Anxiety and Depression Scale at 2 years(Two years)
- Time free from first hospitalization or emergency department presentation(Two years)
- Change from baseline in COPD Assessment Test at 6 months(6 months)
- Change from baseline in COPD Assessment Test at 2 years(Two years)
研究者
研究点 (6)
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