Remote Care for CIED Patients in Korea

Arrhythmias, Cardiac Clinical Trial

Official title:

Quality and Satisfaction in CIED Remote Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557111
• Other study ID #: Remote Care Study
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2023
• Source: Saint Vincent's Hospital, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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))

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

Device:
• remote monitoring
CIED monitoiring with remote monitoring device

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon	Kyonggi Do

Sponsors (2)

Lead Sponsor	Collaborator
Saint Vincent's Hospital, Korea	Biotronik SE & Co. KG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	Any changes in prescription or patient visit schedule	Any changes in prescription or patient visit schedule based on remote monitoring	1 year
Secondary	Out patient clinic time consumption per patient	Out patient clinic time consumption per patient	1 year
Secondary	Changes in CIED parameters	Changes in CIED parameters during remote monitoring	1 year
Secondary	Any cardiocerebrovascular events, deaths	Any cardiocerebrovascular events, deaths	1 year
Secondary	Admission for heart failure or any cardiovascular intervention	Admission for heart failure or any cardiovascular intervention	1 year