Remote MONITORing of Patients With Chronic Obstructive Pulmonary Disease Using a Tablet System. A Randomized Cross Over Pilot Study of Feasibility Evaluation and Quality of Life Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change of SF-12 over each treatment period
研究概览
简要总结
This clinical investigation will evaluate the patient-equipment interface and patient preference in the use of modern possibilities for remote monitoring of patients with COPD in a personalized care approach.
详细描述
The primary objective is to evaluate the impact and feasibility of tele monitoring and video contact in personalized care of moderate and severe COPD patients. This should be compared to normal standards of care. The cross-over design evaluates the influence on general HRQOL of this tablet and monitoring system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate and provision of informed consent
- •Diagnosis of COPD
- •FEV1/FVC (post bronchodilator) <0.7
- •GOLD severity grade D
- •FEV, < 80% predicted
- •Cognitive ability relevant for the studies as judged by the investigator
- •Living in their own home and able to manage their activities of daily living
排除标准
- •Rapidly progressing severe disease other than COPD and COPD-related diseases, influencing the Health-Related Quality of Life (HRQOL) during the study time as judged by the investigator
- •Long-term stay ( >2 weeks) away from home during the study period, where there are no possibility to get internet connection
- •COPD exacerbation during 1 month before start of study
结局指标
主要结局
Change of SF-12 over each treatment period
时间窗: 13 month study, measure points at day 0 (1), week 26 (2), week 30 (3) and week 56 (4)
The primary objective is to evaluate the impact and feasibility of tele monitoring and video contact in personalized care of moderate and severe COPD patients. This should be compared to normal standards of care. The cross-over design evaluates the influence on general HRQOL of this tablet and monitoring system.
次要结局
未报告次要终点