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临床试验/NCT04557111
NCT04557111已完成不适用

Quality and Satisfaction in CIED Remote Monitoring

Saint Vincent's Hospital, Korea1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Satisfaction measurement before and after remote monitoring

研究概览

简要总结

This trial is for monitoring the quality and satisfaction of CIED patients who are naive with remote device monitoring.

详细描述

Patient satisfaction (using questionnaire) before and after wireless/wired monitoring and outpatient treatment time, variables in heart transplantation devices for wireless/wired monitoring, presence of heart failure, cardiovascular events such as arrhythmia, myocardial infarction or cerebral infarction, thromboembolism and admission related to cardiovascular cause. The questionnaire was adopted and modified from modified Korean version of HoMASQ (by YouMi Hwang,2021 from HoMASQ; Europace (2010))

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Biotronic CIED implanted in St. Vincent's Hospital, Catholic University of Korea, Republic of Korea
  • Patients who are literate and have perceptibility on questionnaire
  • Patients who followed up more than 6 months after CIED implantation
  • Patients with age of >20 years

排除标准

  • Patients with < 2 outpatient clinic visits during >6 months
  • Illiterate patients or inapprehensive of questionnaire
  • Patients with life expectancy of <1 year

结局指标

主要结局

Satisfaction measurement before and after remote monitoring

时间窗: 1 year

Satisfaction measurement by questionnaire: Survey on telehealth patient experience(modified Korean version by YouMi Hwang,2020 from Bas-Villalobos, Form I) and Post remote monitoring satisfaction questionnaire, modified Korean version by YouMi Hwang,2020 from HoMASQ (Home Monitoring Acceptance and Satisfaction Questionnaire, Form II): Usually higher scores mean a worse outcome

次要结局

  • Any changes in prescription or patient visit schedule(1 year)
  • Admission for heart failure or any cardiovascular intervention(1 year)
  • Out patient clinic time consumption per patient(1 year)
  • Changes in CIED parameters(1 year)
  • Any cardiocerebrovascular events, deaths(1 year)

研究者

发起方
Saint Vincent's Hospital, Korea
申办方类型
Other
责任方
Principal Investigator
主要研究者

You Mi Hwang

Assistant Professor in Internal Medicine, Cardiology, Cardiac Electrophysiologist

Saint Vincent's Hospital, Korea

研究点 (1)

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