TARIFF Health Economics Evaluation Registry for Remote Follow up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 6
- 主要终点
- Economic Impact of Remote Monitoring on Hospitals and Patients
研究概览
简要总结
The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy. Aims of the study are to develop a hospital cost minimization analysis and a cost effectiveness analysis based on direct estimation of costs and quality of life deriving from remote follow-up (performed with Merlin@home and Merlin.net) compared to standard follow-up in the management of ICD implanted patients.
详细描述
TARIFF is a prospective observational study aimed to measure direct, indirect costs and quality of life of all participants for the duration of the observational timeframe. Purpose of cost collecting is to include a complete set of medical services and productivity loses that could be directly affected by the different clinical Follow-Up (FU) pathway. The study consists of 2 phases: firstly standard follow up costs will be collected for 100 pts, then all costs associated to remote follow ups will be collected for other 100 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients already implanted with ICD
- •Patients able to be followed in the same centre during all the study
- •Patients with age > 18
- •Patients able to understand and to answer to EuroQoL Group 5-Dimension (EQ-5D) Questionnaire
排除标准
- •Patients pregnant
- •Patients unable to connect Merlin@home transmitters with Website Merlin.net (i.e.without telephonic analogic line or Global System for Mobile Communication (GSM)/Universal Mode Telecommunication System (UMTS) connection)
结局指标
主要结局
Economic Impact of Remote Monitoring on Hospitals and Patients
时间窗: 12 months follow-up
Costs analysis of remote monitoring using Merlin@home and Merlin.net compared to standard follow-up in an Italian real-life setting. Overall mean annual cost per patient: Health Care System (HCS) perspective.
次要结局
- Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN)(1 year)
- Impact of Remote Monitoring on Patients' Quality of Life(baseline, 12 months)