Clinical Trials for Elderly Patients With Multiple Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Restech Srl
- 入组人数
- 312
- 试验地点
- 12
- 主要终点
- Final Utility Index of EQ-5D Questionnaire
研究概览
简要总结
The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other typical comorbidities such as congestive heart failure and sleep disordered breathing. A specific ICT platform in combination with a set of innovative devices will be used to collect and process useful clinical data at the patient's home and used to optimize their medical treatment. To evaluate the impact of this solution, an international multi-centric randomized control trial will be implemented in five European regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social and organizational contexts in Europe.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD GOLD grade II or higher with a prior history of exacerbations and/or an hospitalization for COPD in the previous year with one or more documented non-pulmonary chronic conditions such as:
- •CHF due to left ventricular systolic dysfunction (LVSD) confirmed on echocardiography
- •SDB identified by respiratory sleeping studies or polysomnography
- •current or prior smoking history of >= 10 pack/years
- •subjects capable of providing signed written informed consent
- •subjects capable of perform study procedures and use the RESMONPRO at home
- •subjects with reliable mobile phone coverage at home
排除标准
- •Any disease that, in the opinion of the investigator, put the subject at risk
- •subjects with significant vision disturbance and mental diseases
- •subjects with a planned prolonged absence from home
结局指标
主要结局
Final Utility Index of EQ-5D Questionnaire
时间窗: 9 months
The quality of life of patients as quantified by the final utility index of the EQ-5D questionnaire. The utility index ranges from -0.074 to 1 with 1 being the highest possible quality of life.
Time to First Hospitalization
时间窗: From enrolment up to 9 months
It represents the number of days, since the enrolment into the study, to the first hospitalization
次要结局
未报告次要终点