Remote Care for CIED Patients in Korea

Completed

• Conditions: Arrhythmias, Cardiac

• Registration Number: NCT04557111
• Lead Sponsor: Saint Vincent's Hospital, Korea

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))

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Study Start: 2021-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2022-12-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Satisfaction measurement before and after remote monitoring	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 Outcome Measures

Name	Time	Method
Any changes in prescription or patient visit schedule	1 year	Any changes in prescription or patient visit schedule based on remote monitoring
Admission for heart failure or any cardiovascular intervention	1 year	Admission for heart failure or any cardiovascular intervention
Out patient clinic time consumption per patient	1 year	Out patient clinic time consumption per patient
Changes in CIED parameters	1 year	Changes in CIED parameters during remote monitoring
Any cardiocerebrovascular events, deaths	1 year	Any cardiocerebrovascular events, deaths

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇰🇷 Suwon, Kyonggi Do, Korea, Republic of