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临床试验/NCT04599114
NCT04599114尚未招募不适用

Virtual for Care Atrial Fibrillation Patients Using VIRTUES (Virtual Integrated Reliable Transformative User-Driven E-Health System)

Lawson Health Research Institute6 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
6
主要终点
Number of patients who present to the emergency department due to atrial fibrillation, after their index visit

研究概览

简要总结

Patients will atrial fibrillation, a type of irregular heart rhythm, frequently go to the emergency room in order to manage their condition. This study will use a chart review to look at the characteristics and frequency of atrial fibrillation patients who go to the emergency room. In addition to the chart review, patients with atrial fibrillation who have recently gone to the emergency room or have been hospitalized will be approached and asked if they want to use an electronic health care system that can be accessed by both themselves and their health care providers. Along with the system, patients will be given a Health Canada approved heart rhythm sensor, so patients will be able to record their heart rhythm when they feel symptoms and send the information to the heart rhythm team. The heart rhythm team will then make real-time recommendations to the patient about how they can manage their rhythm and symptoms. Patients will be asked to complete satisfaction and quality of life surveys. Our goal is to provide efficient and effective care for patients with AF, resulting in decreased repeat ED visits.

详细描述

See brief summary.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

  • able to provide informed consent
  • documented symptomatic new-onset or pre-existing, non-valvular AF
  • ER visit or hospitalization for primary AF in the last 6 months
  • proficient in the English language

排除标准

  • unable to provide informed consent
  • planning to move/relocate during the period of study
  • current pregnancy
  • patient is a prisoner/incarcerated
  • no access to a smart device with Bluetooth capabilities
  • planned percutaneous coronary intervention, coronary artery bypass graphing or heart valve surgery within the next year
  • any medical condition making 1 year survival unlikely

结局指标

主要结局

Number of patients who present to the emergency department due to atrial fibrillation, after their index visit

时间窗: 12 months

See title

次要结局

  • Utility of the system(12 months)
  • Time to stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death(12 months)
  • Survey-based experience with the VIRTUES application(Baseline, 3 months, 12 months)
  • Pre and post patient reported outcomes using the Atrial Fibrillation Effect on Quality of Life (AFEQT) Questionnaire and the EQ-5D-5L(Baseline, 3 months, 12 months)
  • Frequency of stroke/TIA, systematic embolism, cardiovascular (CV) hospitalization, death(12 months)
  • Number of AF-related ER visit per patient, post index visit(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Allan Skanes

Director, Electrophysiology Laboratory

Lawson Health Research Institute

研究点 (6)

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