Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Clinical features
研究概览
简要总结
The purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers.
The initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.
详细描述
Cardiovascular Diseases are a major cause of global morbidity and mortality, being responsible according to the World Health Organization of the 30% of overall mortality.
Since 2001 that the first pacemaker of remote monitoring was implanted in Europe, more than 300,000 pacemaker have been implanted around the world. Despite this sharp expansion, the scientific evidence on economic evaluations of pacemaker with remote monitoring is very limited, and in our knowledge, studies including informal costs have not been conducted.
In the field of cardiology, telemedicine allows consultations with patients through monitoring systems and remote communication analyzing the ongoing heart rates of people with pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and subcutaneous Holter. The use of remote monitoring may save time and efforts to both healthcare professionals and patients, including their informal caregivers, reducing the number of follow up visits to the hospital and reducing the associated costs with patient follow-up, which will help to improve sustainability of healthcare services.
During the 12 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 4 different moments (pre-implant and months 1, 6, 12 and 5 years post-implantation).
The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of health-related quality of life, functional capacity questionnaires and 3) Finally, the hospital and informal costs of patients with pacemakers will be estimated by the researches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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
- •Be 18 years of age
- •Have a pacemaker implanted
- •Understand and be able to properly perform self-monitoring at home
排除标准
- •Be participating in another study
- •Refuse to participate in the study
- •Have implanted a different cardiac device to the pacemaker
结局指标
主要结局
Clinical features
时间窗: 12 months
Selected variables from the medical history records: * gender * age * indication for the implantation of the pacemaker. * comorbidities * pharmacological treatment * vital signs * pacemaker parameters
次要结局
- Direct costs(5 years)
- Number of patients with Adverse Events(5 years)
- Consultations and Hospitalizations unscheduled(5 years)
- Health-Related Quality of Life(5 years)
- Informal costs(5 years)
- Functional capacity(5 years)
- Indirect cost(5 years)
研究者
Antonio Lopez Villegas
PhD student
Universidad de Almeria