Remote Care for CIED Patients in Korea

Quality and Satisfaction in CIED Remote Monitoring

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

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: remote 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 Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyonggi Do
    • Suwon, Kyonggi Do, Korea, Republic of, 16247
      • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study includes Biotronic CIED implanted patients in St. Vincent's Hospital, Catholic University of Korea, Republic of Korea. Study population are included if they are more than 20year old, followed up at outpatient clinic > 6 months after CIED implantation, and are literate and have perceptibility on questionnaire.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Saint Vincent's Hospital, Korea
• Collaborators: Biotronik SE & Co. KG
• Investigators: Principal Investigator: YouMi Hwang, MD, PhD, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac resynchronization therapy; pacemaker; Implantable Cardioverter Defbrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: Remote Care Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No