Prospective Registry for the Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator (ICD) Recipients in the Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,650
- 试验地点
- 73
- 主要终点
- Sensitivity, positive predictive value and expected utility of the organizational model
研究概览
简要总结
The purpose of the registry is to evaluate an organizational model fixing roles and behaviors of subjects involved in the remote monitoring of patients implanted with pacemakers and defibrillators.
The evaluation will estimate the clinical efficiency and the impact on health service resources of the organizational model when this is implemented in the daily clinical practice.
详细描述
After a number of studies which assessed technical reliability and clinical implications of remote monitoring systems, a further step should approach the issue of how remote monitoring can be implemented as a part of routine activities of a cardiology outpatient clinic. A clear definition of roles and workflow to timely manage information and properly react to adverse events is required. The HomeGuide Registry proposes an organizational model specifying roles and procedures for outpatient clinics using a specific remote monitoring system in routine follow-up. The HomeGuide model is essentially based on an interaction between one or more allied professionals (expert and trained nurses or technicians) and a responsible physician. The main objective of the HomeGuide Registry is to evaluate:
- Clinical efficiency of remote patient management;
- Health service resources required by a remote patient management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients implanted with a BIOTRONIK pacemaker or ICD with Home Monitoring (HM) technology
- •Ability to utilize the HM system throughout the study
- •Ability to give informed consent
- •Ability to return for regular follow-ups for two years
排除标准
- •Patients who do not fulfill all inclusion criteria
结局指标
主要结局
Sensitivity, positive predictive value and expected utility of the organizational model
时间窗: Up to two years
Sensitivity, positive predictive value and expected utility in the detection of all cardiovascular and device-related events of the proposed organizational model
次要结局
- Manpower of the organizational model(Up to two years)
研究者
Renato Pietro Ricci
Principal Investigator
San Filippo Neri General Hospital
