Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers
Sustainability of Cardiology Services: Economic Evaluation and Communication in Remote Monitoring of People With Pacemakers.
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.
研究概览
详细说明
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:
- Remote monitoring group: Biotronik Estella SR-T and DR-T & Biotronik Evia SR-T and DR-T.
- Hospital monitoring group: St Jude Medical Endurity SR and DR & Sorin Reply 200 SR and DR.
The study will estimate: 1) The Clinical features of the patients. 2) The effectiveness through of administration of Health-Related Quality of Life questionnaires and 3) Finally, hospital and informal costs of patients with pacemakers will be estimated by the researches.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Nordland
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Bodo、Nordland、挪威、N - 8092
- Nordland Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Be 18 years of age
- Have a pacemaker implanted
- Understand and be able to properly perform self-monitoring at home
Exclusion Criteria:
- Be participating in another study
- Refuse to participate in the study
- Have implanted a different cardiac device to the pacemaker
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:心脏起搏器的医院监测
患者必须去医院接受监测
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实验性的:起搏器的远程监控
远程医疗系统: 患者不必去医院接受监测 |
远程医疗系统用于远程监护组
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical features
大体时间:6 months
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Selected variables from the medical history records:
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health-Related Quality of Life
大体时间:6 months
|
EuroQol-5Dimensions (EQ-5D)
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6 months
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Health-Related Quality of Life
大体时间:6 months
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Minnesota Living With Heart Failure Questionnaire (MLHF)
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6 months
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Safety
大体时间:6 months
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6 months
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|
Consultations and Hospitalizations unscheduled
大体时间:6 months
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Number of unscheduled visits and hospitalizations
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6 months
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Direct costs
大体时间:6 months
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Direct costs taken into account:
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6 months
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Indirect cost
大体时间:6 months
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Maintenance of the medical consultation (hospital):
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6 months
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Informal costs
大体时间:6 months
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Costs related to the care and displacements of patients to hospital:
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6 months
|
合作者和调查者
出版物和有用的链接
一般刊物
- Lopez-Villegas A, Catalan-Matamoros D, Peiro S, Lappegard KT, Lopez-Liria R. Cost-utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial. PLoS One. 2020 Jan 29;15(1):e0226188. doi: 10.1371/journal.pone.0226188. eCollection 2020.
- Lopez-Liria R, Lopez-Villegas A, Enebakk T, Thunhaug H, Lappegard KT, Catalan-Matamoros D. Telemonitoring and Quality of Life in Patients after 12 Months Following a Pacemaker Implant: the Nordland Study, a Randomised Trial. Int J Environ Res Public Health. 2019 Jun 5;16(11):2001. doi: 10.3390/ijerph16112001.
- Lopez-Villegas A, Catalan-Matamoros D, Lopez-Liria R, Enebakk T, Thunhaug H, Lappegard KT. Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial. BMC Geriatr. 2018 Sep 21;18(1):223. doi: 10.1186/s12877-018-0911-3.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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