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Feasibility Study of mCardia: A Context-aware ECG monitoring system for arrhythmia screening

mCardia is a context-aware ECG collection system for arrhythmia (irregular heartbeat) screening. The purpose of this study is to assess the feasibility, usefulness, and usability of mCardia in ambulatory real-world use.

mCardia is a context-aware ECG collection system for arrhythmia (irregular heartbeat) screening. This will enable longitudinal contextualized ECG collection in a natural setting and help in optimizing the diagnosis of atrial fibrillation. 

The aim of the mCardia system is threefold:

  1. To collect contextual data (both self-reported and passive) such as unusual symptoms (dizziness, palpation, heartburn, etc.) and their duration, activities (walking, running, exercising, etc.), body position, sleep, food intake and synchronize them with the ECG recordings in order to give a contextualized understanding of the ECG to the cardiologist.

  2. To reduce recall bias in patient-reported events during ambulatory long-term ECG monitoring.

  3. To improve doctor and patient communication during longitudinal arrhythmia screening periods (week long) and help the patient in keeping track of unusual symptoms.

mCardia has been developed as a part of the REAFEL (Reaching the Frail Elderly Patient for Optimizing Diagnosis of Atrial Fibrillation) project which is funded by the Innovation Fund Denmark.  The mCardia team includes computer scientists, engineers, cardiologists, and user interface designers from the Copenhagen Center for Health Technology (CACHET), the Technical University of Denmark (DTU), and the Department of Cardiology (Y) at Bispebjerg and Frederiksberg Hospital (BFH).

The purpose of this study is to assess the feasibility, usefulness, and usability of the mCardia system. Hence, this is a technical study and not a clinical study.

What would I get out of it ?

You get to visualize the trends in your heart rhythm and heart rate variability under different contexts throughout the day. You get to understand your sleep rhythm, number of steps taken in a day, metabolic rate, and average active time in a day. If you are interested in using your data we can share your recorded ECG data with you for the entire study duration.

Please note that mCardia does not give you arrhythmia information in the app itself, but you may share the data collected via mCardia with your cardiologist for diagnosis of arrhythmias.

What should I do?

You will be given an ECG monitor which will be connected to your own phone. In case you don’t have an Android phone or you don’t want to use your own phone, you will also be given a phone to be used during the study. The study is conducted from home in your natural setting. You will be asked to wear the ECG monitor all the time, also during the night, and use the mCardia mobile app to add supplementary information like recording event, unusual symptoms you experience, daily food intake, etc.

Orientation meeting

At the first meeting, you will be given a kit containing an ECG monitor, a phone (if you need this), charging cables, and a user manual to understand the app and the ECG monitor functions. You will be asked to sign a consent form in the mCardia app and provide some details regarding demography, medical history (related to heart diseases), medication, and previous ECG monitoring experience. At this meeting, you are also instructed on how to use the app and how to take care of the ECG device (charging, putting on and taking off, etc.)

During the study period

You are asked to wear the ECG Holter and use mCardia for a minimum of 3 days. Maximum can be longer, up to 1-2 weeks, if you would like to monitor yourself for a longer period.

Interview

At the end of the study period, there will be a qualitative interview and questionnaire asking about your feedback on the app's usefulness and usability.

More about the equipment

You will receive a Movisens single-lead ECG monitor which collects ECG, HR, HRV, step count, body position (standing, sitting, lying), and movement patterns (accelerometer). This device sends the data to the mCardia app via Bluetooth. The ECG monitor is CE marked and hence adheres to all relevant health, safety, and environmental protection standards. Note however, that the Movisens device is not a CE certified medical device and as such, cannot be used for clinical diagnosis. 

 ECG with electrodes

 mCardia App

Movisens EcgMove 4 mCardia App

Inclusion criteria

Any individual aged 40 and above who is interested in heart arrhythmia monitoring. This also includes individuals who have previous experience with more traditional ECG Holter monitoring.

Exclusion criteria

Individuals with any type of serious health problems and individuals who are not familiar or comfortable using mobile phones or apps, and wearable devices. 

Who will have access to your information?

You data will be shared only within the research group comprising of researchers at CACHET including researchers at DTU and BFH department Y.

Your name or identity will not be disclosed in reports or publications produced by the project. We can share your recorded ECG data with you for the entire study duration, after the study. Your feedback and experience of using the mCardia system will be used for improving the system, and published anonymously in scientific journals and used for presentations at conferences.

All data gathered during the study is stored in secure cloud servers of CACHET.

You can read the informed consent form before starting the study and you are must agree to the terms in order to continue.

This study has been reported to the Danish Ethics Committee and has been excepted for ethical approval due to its technical rather than clinical focus. (File no. H-19071015).

Download

mCardia is currently only available on Android and can be downloaded from Google Play here.

Contact Information

For practical and technical questions, you can reach Devender Kumar at deku@dtu.dk or +45 7132 1818

 

Contact

Devender Kumar
PhD student
DTU Health Tech
+45 45 25 52 64
https://www.cachet.dk/research/studies/mcardia
30 MAY 2020