RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 6
- 主要终点
- Health-Related quality of life
研究概览
简要总结
The purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. In addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.
详细描述
The study is designed to evaluate the impact of telemonitoring on the management of COPD compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to improve COPD patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •COPD GOLD class 3-4
- •Life expectance > 12 months
排除标准
- •Patient unable to use the equipment provided (alone or assisted).
研究组 & 干预措施
Control group
Treatment as usual
Self monitoring for patients with COPD
Procedure: self-monitoring for patients with severe COPD
干预措施: self-monitoring for patients with severe COPD (Procedure)
Nurse monitoring for patients with COPD
Procedure: nurse-monitoring for patients with severe COPD
干预措施: nurse-monitoring for patients with severe COPD (Procedure)
结局指标
主要结局
Health-Related quality of life
时间窗: 12 months
Health-Related Quality of Life is assessed by the SF-36 questionnaire
次要结局
- Number of bed days for hospitalised patients(12 months)
- Number of specialist visits(12 months)
- All cause mortality(12 months)
- Number of visits to emergency department(12 months)
- Anxiety and depression status(12 months)
- Number of re-hospitalizations(12 months)