HELP-A study is a single-center, randomized, controlled trial. A total of 588 patients enrolled during the 2 years of enrollment period and followed for 1 month of follow-up period. This study aims to compare diagnostic yield between continuous ECG Patch and intermittent handheld ECG in patients with arrhythmia symptoms.
HELP-A study is a single-center, randomized, controlled trial designed to compare diagnostic yield, arrhythmia detection rate, user convenience, and cost-effectiveness between continuous ECG Patch and intermittent handheld ECG in patients with arrhythmia symptoms. Patients who have symptoms of arrhythmia but are not diagnosed on a 12-lead ECG and require additional tests. A total of 588 patients enrolled during the 2 years of enrollment period and followed for 3 month of follow-up period. Patients will be assigned to continuous patch ECG or intermittent handheld ECG and will be examined for one month. If there is no diagnosis after a month, the patient will be crossed over to another device and examined for another month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
588
Using a continuous patch ECG for 1 week during 1 month
Using a handheld ECG twice daily and when symptoms are present during 1 month
Chonnam National University Hospital
Gwangju, Dong-gu Jaebongro 42, South Korea
RECRUITINGWonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
RECRUITINGHallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, Hwaseong-si Keunjaebong-gil 7, South Korea
RECRUITINGDiagnostic yield
(Number of patient with triggered event without arrhythmia + Number of patients with clnically significant arrhytmia) / total patients
Time frame: 1 month
Arrhythmia detection rate
Compare the arrhythmia diagnosis rate between the two devices.
Time frame: 3 month
Cost-effectiveness
Compare Total medical cost incurred for arrhythmia symptoms between the two devices
Time frame: 3 month
Chagne of Quality of Life
Compare Quality Of Life using Euro QOL-5D-5L between the two devices
Time frame: Baseline, 3 month
User convenience
Comparison of User convenience using questionnaires in patients who used both devices (ease, portability, satisfaction, etc.) The questionnaire consists of 5 scales from 1 to 5
Time frame: 3 month
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