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Clinical Trials/NCT04557111
NCT04557111
Completed
Not Applicable

Quality and Satisfaction in CIED Remote Monitoring

Saint Vincent's Hospital, Korea1 site in 1 country102 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arrhythmias, Cardiac
Sponsor
Saint Vincent's Hospital, Korea
Enrollment
102
Locations
1
Primary Endpoint
Satisfaction measurement before and after remote monitoring
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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))

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Saint Vincent's Hospital, Korea
Responsible Party
Principal Investigator
Principal Investigator

You Mi Hwang

Assistant Professor in Internal Medicine, Cardiology, Cardiac Electrophysiologist

Saint Vincent's Hospital, Korea

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Satisfaction measurement before and after remote monitoring

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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