Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Feb 15, 2018
Date Accepted: Apr 15, 2018
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A Novel 12-Lead Electrocardiographic System for Home Use: Development and Usability Testing
Background:
Cardiovascular diseases (CVD) are the leading cause of morbidity and mortality worldwide. Early diagnosis is of pivotal importance for patients with cardiac arrhythmias and ischemia to minimize the consequences like strokes and myocardial infarctions. The chance of capturing signals of arrhythmias or ischemia is substantially high when a 12-lead electrocardiogram (ECG) can be recorded at the moment when a patient experiences the symptoms. However, until now, available diagnostic systems (Holter monitors and other wearable ECG sensors) have not enabled patients to record a reliable 12-lead ECG at home.
Objective:
The objective of this project was to develop a user-friendly system that enables persons with cardiac complaints to record a reliable 12-lead ECG at home to improve the diagnostic process and, consequently, reduce the time between the onset of symptoms and adequate treatment.
Methods:
Using an iterative design approach, ECGraph was developed. The system consists of an ECG measurement system and a mobile app, which were developed with the help of several concept tests. To evaluate the design, a prototype of the final design was built and a final technical performance test and usability test were executed.
Results:
The ECG measurement system consists of a belt and 4 limb straps. Ten wet Ag/AgCl electrodes are placed in the belt to optimize skin-electrode contact. The product is controlled via an app on the mobile phone of the user. Once a person experiences symptoms, he or she can put on the belt and record ECGs within a few minutes. Short instructions, supported by visualizations, offer guidance during use. ECGs are sent wirelessly to the caregiver, and the designated expert can quickly interpret the results. Usability tests with the final prototype (n=6) showed that the participants were able to put on the product within 8 minutes during first-time use. However, we expect that the placement of the product can be executed faster when the user becomes more familiar with the product. Areas of improvement focus mainly on confidence during product use. In the technical performance test, a 12-lead ECG was made and reproduced 6 times.
Conclusions:
We developed a new 12-lead ECG system for home use. The product is expected to be more user-friendly than current hospital ECG systems and is designed to record more reliable data than current ECG systems for home use, which makes it suitable for expert interpretation. The system has great potential to be incorporated into an outpatient practice, so that arrhythmias and ischemia can be diagnosed and treated as early as possible.
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