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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04557111
Other study ID # Remote Care Study
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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