Remote Care for CIED Patients in Korea

NCT04557111 | Completed

• 1 other identifier: Remote Care Study
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arrhythmias, Cardiac

Keywords

pacemaker; Implantable Cardioverter Defbrillator; Cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Any changes in prescription or patient visit schedule

  1 year

• Out patient clinic time consumption per patient

  1 year

• Changes in CIED parameters

  1 year

• Any cardiocerebrovascular events, deaths

  1 year

• Admission for heart failure or any cardiovascular intervention

  1 year

Interventions

remote monitoring DEVICE

CIED monitoiring with remote monitoring device

Eligibility Criteria

• Age: 20 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Saint Vincent's Hospital, Korea: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (1)

St. Vincent's Hospital

Suwon, Kyonggi Do, 16247, South Korea

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• YouMi Hwang, MD, PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Internal Medicine, Cardiology, Cardiac Electrophysiologist

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

KR (1)