PORTuguese Research on Telemonitoring With CareLink® (PORTLink)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 12
- 主要终点
- Number of Patient Satisfied or Very Satisfied With Carelink
研究概览
简要总结
Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)
详细描述
The objective of the PORTLink (PORTuguese Research on Telemonitoring with CareLink), a multicenter randomized study, is to assess the safety, functioning and costs of remote ICD monitoring when compared to traditional in-clinic follow-up. It will evaluate aspects such as the clinician and patient acceptance and satisfaction with the reviewing device data via the website, the complexity for troubleshooting calls to the support center, the utilization of emergency resources by symptomatic patients, the percentage of the unscheduled appointments after a remote interrogation, the levels of anxiety, depression and quality of life, and the main consumed resources with CareLink System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Subject has implanted Medtronic Implantable Cardioverter Defibrillator: CRT-D (Cardiac Resynchronization Therapy - Defibrillator), ICD
- •Subject or the subject's caregiver is willing and able to use the Medtronic CareLink Monitor and perform the required duties at home or have a family member or assistant to perform those studies
- •Subject has signed a Patient Informed Consent Form from this study
排除标准
- •Subject has medical condition(s) that would limit study participation (e.g. hearing or speech impaired with no family member or assistant available)
- •Subject is less than 18 years of age
- •Subject is enrolled or intends to participate in another clinical trial
结局指标
主要结局
Number of Patient Satisfied or Very Satisfied With Carelink
时间窗: 12 months visit
through the semi-quantitative evaluation of patient satisfaction with Carelink System and their preference when compared to traditional in-clinic follow-up, the options were: 1) Very Satisfied; 2) Satisfied; 3) Not Satisfied nether Unsatisfied; 4) Unsatisfied; 5)Very Unsatisfied
次要结局
- Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings(12 months visit)
- Health Care Consumed Resources Between Groups Relative to Unscheduled Visits(12 months visit)
- Improvement in Quality of Life(12 months visit)
- Number of Device Related Adverse Events(12 months visit)
- Number of Unanticipated Serious Adverse Device Effects (USADE) Rate(12 months visit)
- Compare Patient Consumed Resources Between Groups(Baseline)