RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 16
- 主要终点
- Combined end point of all cause mortality and number of hospitalisations for heart failure
研究概览
简要总结
The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.
详细描述
The study is designed to evaluate the impact of telemonitoring on the management of CHF compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to reduct the combined end point of all cause mortality and re-hospitalizations, as well as the other kinds of access to hospital facilities (bed-days, specialistic and ER visits). The trial will examine whether the CHF patients improve their health-related quality of life and reduct the anxiety about health conditions, thanks to the telemonitoring. 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 professional 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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years.
- •Discharge from hospital after acute heart failure in the previous 3 months and EF < 40% or EF > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization
排除标准
- •Comorbidities prevalent on CHF with life expectation < 12 months.
- •Impossibility or inability to use the equipment and help at home not available.
- •Myocardial infarction or percutaneous coronary intervention in the last 3 months or scheduled.
- •Coronary artery bypass, valve substitution or correction in the last 6 months.
- •Being on waiting list for heart transplantation.
- •Being enrolled in other trial
研究组 & 干预措施
Control group
Treatment as usual
Telemonitoring for patients with Congestive Heart Failure
干预措施: Telemonitoring for patients with Congestive Heart Failure (Procedure)
结局指标
主要结局
Combined end point of all cause mortality and number of hospitalisations for heart failure
时间窗: 12 months
次要结局
- Number of hospitalisations (including rehospitalisations) for all causes and for heart failure(12 months)
- Number of specialist visits(12 months)
- Total number of days in hospital(12 months)
- Number of visits at emergency department for heart failure(12 months)
- Cardiovascular and all-cause mortality(12 months)
- Health-Related Quality of Life(12 months)
- Anxiety and depression status(12 months)