Remote Care for CIED Patients in Korea

Saint Vincent's Hospital, Korea102 enrolled

Overview

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

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))

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Arrhythmias, Cardiac

Interventions

remote monitoringDEVICE

CIED monitoiring with remote monitoring device

Eligibility

Sex: ALLMin age: 20 YearsMax age: 110 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with Biotronic CIED implanted in St. Vincent's Hospital, Catholic University of Korea, Republic of Korea 2. Patients who are literate and have perceptibility on questionnaire 3. Patients who followed up more than 6 months after CIED implantation 4. Patients with age of \>20 years Exclusion Criteria: 1. Patients with \< 2 outpatient clinic visits during \>6 months 2. Illiterate patients or inapprehensive of questionnaire 3. Patients with life expectancy of \<1 year

Locations (1)

St. Vincent's Hospital

Suwon, Kyonggi Do, South Korea

Outcomes

Primary Outcomes

Satisfaction measurement before and after remote monitoring

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

Time frame: 1 year

Secondary Outcomes

Any changes in prescription or patient visit schedule

Any changes in prescription or patient visit schedule based on remote monitoring

Time frame: 1 year

Out patient clinic time consumption per patient

Time frame: 1 year

Changes in CIED parameters

Changes in CIED parameters during remote monitoring

Time frame: 1 year

Any cardiocerebrovascular events, deaths

Time frame: 1 year

Admission for heart failure or any cardiovascular intervention

Time frame: 1 year

Data from ClinicalTrials.gov

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