Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 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 06 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 3 different moments (pre-implant and months 1, and 6 post-implantation).
Pacemakers that are going to be used in the project:
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
研究组 & 干预措施
Hospital monitoring of pacemakers
Patients have to go to the hospital to be monitorized
Remote monitoring of pacemakers
Telemedicine System:
Patients have not to go to the hospital to be monitorized
干预措施: Telemedicine System (Device)
结局指标
主要结局
Clinical features
时间窗: 6 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
- Health-Related Quality of Life(6 months)
- Indirect cost(6 months)
- Consultations and Hospitalizations unscheduled(6 months)
- Informal costs(6 months)
- Safety(6 months)
- Direct costs(6 months)
研究者
Antonio Lopez Villegas
PhD student
University of Tromso