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临床试验/NCT02585817
NCT02585817已完成不适用

Remote Patient Management for Cardiac Implantable Electronic Devices - A Pilot Study

Ratika Parkash2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2016年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
176
试验地点
2
主要终点
Generalizability: Measurement of generalizability will be done by measuring the number of patients eligible for remote patient management as a proportion of all CIED patients.

研究概览

简要总结

This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote CIED monitoring and programming. The advancement in technology is very important as it addresses several potential gaps and barriers in the care of patients with CIEDS:

  1. Long, expensive travel for patients
  2. Morbidity to patients due to delay in receiving appropriate treatment
  3. Efficiency in health care delivery
  4. Patient satisfaction

详细描述

Canada is a country with a diverse geography, of which 19% of the inhabitants are in communities classified as 'rural', but many may still have long distances to travel to reach a health care facility. This results in challenges in uniform delivery of health care throughout the country. There are 25,000 pacemaker (PM) implants and 7000 implantable defibrillator (ICD) implants yearly in Canada, with approximately 120 000 patients living with these devices. The recommended follow-up for these devices are based on consensus and position statements, with the majority of patients requiring at least yearly visits to a specialized device clinic during the lifetime of their device. During the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated.

While remote monitoring technology is currently available and has permitted surveillance and device assessment from any patient location accessible to a landline or mobile phone, the use has been inconsistent in Canada. In addition, new technology has become available that not only permits surveillance, but also remote programming of these devices. The incorporation of remote programming capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team and no longer require travel to the specialized 'hub' clinics for follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with an implanted pacemaker/cardiac resynchronization therapy with a pacemaker(CRT-P) capable of remote patient management would be eligible for the study that will be followed by the site where the implantation occurred OR patients with an implanted defibrillator/CRT-D capable of remote patient management where the patients reside in a community OUTSIDE of the site where the implantation occurred. The device may be de novo, existing or a patient undergoing a pulse generator change that now has remote patient management capabilities.
  • Able to provide consent.

排除标准

  • 未提供

研究组 & 干预措施

Remote CIED Management

Experimental

Patients with a CIED will undergo remote monitoring with information technology.

干预措施: Remote CIED Management (Device)

结局指标

主要结局

Generalizability: Measurement of generalizability will be done by measuring the number of patients eligible for remote patient management as a proportion of all CIED patients.

时间窗: 6 months

次要结局

  • Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers(6 months)
  • Compliance (number of received remote transmissions divided by the number of expected remote transmissions)(12 months)

研究者

发起方
Ratika Parkash
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ratika Parkash

Staff Cardiologist

Nova Scotia Health Authority

研究点 (2)

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