跳至主要内容
临床试验/NCT01459874
NCT01459874已完成不适用

Prospective Registry for the Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator (ICD) Recipients in the Clinical Practice

San Filippo Neri General Hospital73 个研究点 分布在 1 个国家目标入组 1,650 人开始时间: 2008年3月最近更新:
适应症

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:

  1. Clinical efficiency of remote patient management;
  2. 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

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

发起方
San Filippo Neri General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Renato Pietro Ricci

Principal Investigator

San Filippo Neri General Hospital

研究点 (73)

Loading locations...

相似试验