Virtual Integrated Reliable Transformative User-driven E-health System for Pacemakers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 848
- 试验地点
- 22
- 主要终点
- Time to major adverse cardiac event (primary safety outcome)
研究概览
简要总结
While remote monitoring (RM) technology is currently available and has permitted surveillance and device assessment from any patient location, the use has been inconsistent in Canada, where only 8500 out of a potential 120 000 patients with cardiac implantable electronic devices (CIEDs) are enrolled in this program. This technology is in widespread use worldwide for all CIEDs but in Canada, it is utilized primarily for implantable defibrillators, but not pacemakers. Whereas most of the trials were designed to evaluate the efficacy of RM in implantable cardioverter defibrillator (ICD) patients, in the pacemaker (PM) population, there has been work performed already to demonstrate an increase in detection of frequency of adverse clinical events and a reduction in reaction time to those events by RM. Based on all the available literature, it appears that RM benefits both patients and healthcare systems. Overall, studies have demonstrated that RM can be used safely in all device patient-populations, with the exception of pacemaker-dependent patients.
There have been no studies that have evaluated RM only follow up, nor have there been any studies evaluating pacemaker-dependent patients. This study that will safely assess the use of RM only, with in-clinic visits when necessary, that uses the patient-centered electronic platform developed by the Cardiac Arrhythmia Network of Canada (CANet) to perform PM follow up safely, in a more cost-effective manner.
详细描述
This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized in a 1:1 fashion, stratified by pacemaker dependence and by center to either remote patient management of standard of care.
Remote patient management (intervention group):
- Patients will be followed by remote monitoring only. Transmissions will occur at six monthly intervals, with no in-clinic visits. If there is an actionable event on the remote transmission, patients will be seen at their closest community device clinic. The proposed intervention would eliminate any routine visits.
- Newly implanted pacemaker patients will be seen after the initial implant at the hub site, within 48 hours and then within 3 months to optimize programming for subsequent RM visits. Thereafter, all follow-up will occur through remote monitoring every six months. Unscheduled remote transmissions may also occur. Using a combination of remote monitoring, and novel technology, VIRTUES, patients will be managed outside of the clinic.
- Patients will be provided with real-time knowledge of success of their remote transmission and the status of the remote through a web-based portal called VIRTUES.
- Virtual patient record - all patient information in the intervention arm will be contained within an information cloud that will be accessible by patients; access to their own data may be granted by the patient themselves to permit delivery of care remotely, and to permit after hours follow up to be performed by the on call personnel.
Standard of care (comparison group):
The standard arm will be required to have in-clinic visits at yearly intervals. These patients would not have access to the virtual patient cloud or to remote monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Patients with a Medtronic or Abbott pacemaker capable of remote monitoring.
- •Able to provide consent.
- •Age >/= 18 years
排除标准
- •No access to a family physician or general practioner
- •Participation in the RPM CIED pilot study
- •Unreliable automated capture verification function by the device in pacemaker-dependent patients
研究组 & 干预措施
Standard of Care
In-clinic visits
干预措施: Standard of care (Other)
Remote Patient Management
Remote monitoring only
干预措施: Remote Monitoring (Device)
结局指标
主要结局
Time to major adverse cardiac event (primary safety outcome)
时间窗: 18 months
Time to major adverse events (death, stroke, hospitalization for a cardiovascular cause, syncope or device-related emergency department visits). Survival free from the primary outcome will be estimated by the Kaplan-Meier method and compared, using the log-rank test. Cox proportional hazard regression analysis will be used to estimate the likelihood of survival, after verifying the proportional hazard assumption.
Cost effectiveness
时间窗: 18 months
Cost comparison between groups (VIRTUES strategy versus Standard of Care). Analysis will take the form of a cost utility analysis with cost effectiveness assessed in terms of the incremental cost per quality life year (QALY)
次要结局
- Quality of Life - Short Form (SF36)(18 months)
- Quality of Life - Florida Patient Acceptance Survey (FPAS)(18 months)
- Quality of Life - Florida Shock Anxiety Scale (FSAS)(18 months)
- Quality of Life - Brief Illness Perception Questionnaire (BIPQ)(18 months)
- Device-related ER visits(18 months)
- Syncope(18 months)
- Time to detection of ventricular arrhythmia events(18 months)
- Atrial fibrillation(18 months)
研究者
Ratika Parkash
Staff Cardiologist Electrophysiologist
Nova Scotia Health Authority