a survey of mhealth and cardiac rhythm management

7/28/2019 A Survey of mHealth and Cardiac Rhythm Management

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A Survey of mHealth and Cardiac Rhythm ManagementValerie Fenster

DePaul University, School of CDM

1 East Jackson Boulevard,Chicago, IL 60604

[email protected]

Jason Friedlander

DePaul University, School of CDM

1 East Jackson Boulevard,Chicago, IL 60604

[email protected]

ABSTRACT

Mobile medical, or mHealth, devices can range from

anywhere from tablet PCs that wirelessly program

implantable pacemakers, to credit card sized hand-held

glucose monitoring devices for diabetes management, to

pocket-sized Smartphones that sense and display

electrocardiograms (EKGs). With this project we

investigated how mobile technology advancements, couple

with wireless and Internet technology can help to augment

traditional tools for cardiac rhythm management (CRM)

while freeing physicians from their desks and exam rooms.

We explored how both clinicians and patients can readily

monitor disease states using mHealth mobile devices, and

do so remotely from the convenience of home or while on

vacation.

Author Keywords

mHealth; portable; pacemakers; defibrillators; smartphones;

mobile technology; cardiac rhythm management; CRM

INTRODUCTION

Practicing medicine with the aid of portable mobile devices

is called mHealth. Medical mobile devices can range from

anywhere from tablet PCs that wirelessly program

implantable pacemakers, to credit card sized hand-heldglucose monitoring devices for diabetes management, to

pocket-sized Smartphones that sense and display

electrocardiograms (EKGs). With this project we

investigated how mobile technology advancements can help

to augment traditional tools for cardiac rhythm management

(CRM), exploring how both clinicians and patients can

readily monitor disease states using mHealth mobile

devices.

Our target audience was patients with heart disease who

either have, or are candidates for, implantable pacemakers

and defibrillators, and who might be either treated by a

clinician using an mHealth device or personally prescribed

one.

OBJECTIVES

The research objectives were to find out:

What type of functionality is currently available topatients & doctors?

Is there an opportunity for device innovationwithin the current market?

How do patients interact with their current non-mHealth devices?

How do doctors interact with their patients andtheir -mHealth devices?

What is the environment that these devices areused in?

Are there hazards to the patient if the device ismisused?

What are the overall benefits from using anmHealth device?

The following steps were taken to find answers to our

objectives:

Literature search and review past of usabilitystudies for current solutions

Expert Analysis of current solutions Requirements gathering for new solution Develop Happy Path with context scenario Low-fidelity prototype Mid-fidelity prototype Test new design Report findings and recommendations

The healthcare sector has never been known for being an

early adopter of information technology. However, wireless

devicesalong with wireless broadband data networks and

mobile software applicationsare being recognized as

fundamental components in the quest to expand and

improve patient care, control costs and comply with

government and industry mandates. [3]

The above referenced quote is a problem the medical

profession has had a history of struggling with. In addition

to skyrocketing costs for malpractice insurance and thelower Medicare reimbursements for chronic patient disease,

healthcare practitioners have consistently faced dwindling

funding for purchasing cost-prohibitive hospital equipment

and technology. A solution to these adaptation issues seems

to be the growth of wireless networks and devices.

Clinicians no longer have to be constrained by large-scale

computer systems anchored to power outlets that make it

difficult to sync between the exam room and a largely

mobile world. With the influx of mobile devices and the


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scale of mobile networks, doctors are no longer chained to

their desks. They can monitor and interact with patients on

the fly, either from their hospital or the golf course.

There are many moving parts that make up the connected

mHealth world, with each of those parts having to be

connected and in sync to deliver high quality and safe

healthcare to patients. The roles within the current

Healthcare system include patients, physicians, nurses, andhealthcare providers. Each of the roles represents a person

that uses a mobile device such as a mobile phone to

communicate with the server setup in the care center such

that he or she can go around without restrictions. [4]

A great example of a hospital embracing mHealth is in

Florida. A series of cardiac professionals made a pitch to

the hospital, suggesting that specialty trained physicians

having the ability to monitor, and even adjust, a patients

cardiac device from a distance would lead to fewer team

hours in the hospital. Remote programming, as opposed to

the overhead of the doctor being present and the patient

visiting the clinic, takes a fraction of the time.

In order to deliver the proper care, this hospital has

developed a system for wireless real-time monitoring and

reprogramming of cardiac devices, including pacemakers

and defibrillators, using an iPad. It is as simple as a doctor

suggesting changes to a cardiac devices settings, and then

relaying the information for a nurse in the hospital to

execute using a touchscreen laptop. [5] Remote

adjustments to the patients cardiac device from afar is still

highly controversial; therefore, a nurse is still present with

the patient to follow the physicians orders and to monitor

for adverse cardiac reactions should an error occur.

With all of the great advancements in technology and

patient care there are concerns that come along with it aswell. Many believe that a larger population of people using

mHealth devices will lead to hackers attempting to override

the system and cause damage or even death to patients, but

others see risks in different places. Jim Keller of the ECRI

Institute in Plymouth Meeting, Pennsylvania said, I have

not seen that [wireless medical devices] is a high-profile

target for the hacking community, One of the perspectives I

have is the general proliferation of wireless signals is more

of a concern than hacking, with interference from a variety

of electronic devices. [1]

The Federal Communications Commission (FCC) reserves

varying frequency (Wireless Medical Telemetry Service

WMTS) bands for health care wireless transmission. [2]and the Food and Drug Administration (FDA) publishes

strict guidelines regarding use of RFID and wireless

technology. The FDA cites that rather than hacking, there

exists more danger from the co-existence of medical

devices completing for the same band usage within the

confines of a practical hospital environment.

The literary research we have done clearly states a desire

and need for the continual growth and development of safe

and secure mHealth devices. These type of devices will not

only help save lives but save time and money on a grand

scale for the doctors, hospitals and patients who use them.

ANALYSIS OF CURRENT SOLUTIONS & FUNCTIONALREQUIREMENTS

EKGs provide a seven to twelve second running picture of

the hearts electrical activity. The activity is captured using

a series of external electrodes placed on the skins surfacein twelve strategic positions that allow the physician to

study a panoramic and cross-section view of the heart

muscle. The hearts electrical activity is then traced

allowing the physician to view their patients heart rate and

rhythm.

Figure 1. Standard 12 Lead EKG

EKG machines are generally stationary and kept on a cart in

a clinicians office or exam room and placed near a bedside

or examination table to easily connect the leads or

electrodes to the patients torso and limbs.

Figure 2. Standard 12 Lead EKG bedside monitoring device

Remotely programming patients with pacemakers and

defibrillators is now possible using a product set consisting

of a home transmitter that wirelessly captures heart rate and

rhythm and uploads it to a central web site server where

clinicians can triage data to determine if patients need to


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visit the clinic. Patients with heart failure symptoms can use

hand-held mHealth devices to enter weight gain or loss, and

blood pressure. This is then transmitted along with patient

entered information regarding fatigue, shortness of breath

and trouble walking up stairs.

Figure 3. St. Jude Medicals CRM product suite include

Merlin.netremote care transmission web site (top left),

Merlin@home patient home transmitter (top-right) and the

PAM (Patient Activated Monitor-lower right) heart failure

reporting device.

We reviewed AliveCor (www.AliveCor.com), a real-time

Smartphone app that reads a surface EKG by attaching a

slip-on case to the back of the phone. The case contains two

electrodes that measure the bipolar Lead I between the leftand right limbs, thereby capturing a view of electrical

activity in the heart.

The ability to have your phone tie to your healthcare

record and track medical metrics will have vast

repercussions. Though some arent cleared for sale in US

yet, devices like the AliveCor electrocardiogram can

monitor your heart in real time, send the data to the cloud,

and allow your cardiologist to look at it instantly. Other

devices are turning phones into otoscopes for looking in

your ears, or glucometers for monitoring blood sugar. [6]

Figure 1. AliveCors Lead I EKG sleeve attaches to the back of

a Smartphone. Against the skin, or over clothing, it can

display the users heart rate and rhythm.

This mHealth device is an amazing achievement; however,

there are still issues that need to be resolved before the

FDA and other countrys regulatory bodies will approve

this as a medical device for human use.

Pros Eliminates need for wires or jack attachments, and

need to attach sensor electrodes to the body, but

requires use of a case or sleeve to be attached to

back of iPhone that acts as EKG lead electrode for

the positive and negative poles of Lead I between

the right and left arms.

Can be used over clothing, and on an animal, ontop of fur.

EKG data is transmitted to a cloud where it can bepulled down from the cloud and immediately read

by the clinician.

Cons Only shows one channel EKG, whereas, traditional

EKG devices can administer a12 lead views of the

heart and display multiple channel views of the

heart.

Use error can occur if electrodes on the case getscratched.

Not yet approved by the FDA for human use, nohuman trials yet scheduled, however currently

being used in veterinary trials

Is also being sold as an novel app to sensebiorhythms and mood, so could detract from

corporate brand

Contains no other functionality in the app besidethe EKG recording and sending. There is no other

functionality such as reading of symptoms,

preferences / clinic-doctor information.

No direction how a novice user would read andunderstand the detail.

Could be misunderstood by the laymen. Typicalnon-clinical user would not understand heart

rhythms being relayed by the device.

Simply a recording/transmission tool, rather thanan emergency reporting tool.

CARDIOCARE CONTEXT SCENARIO

We added to current cardio mHealth systems by, in addition

to reading, displaying and transmitting real-time EKGs,

including symptomatic heart failure reporting, 911 calling

and clinician supervised set-up to ensure patient safety via

identification of timely, triaged data.

The following images represent design sketches and a

context scenario making up the Happy Path through an
http://techcrunch.com/2011/08/23/alivecor-turns-mobile-devices-into-low-cost-heart-monitors-raises-3-million/http://techcrunch.com/2011/08/23/alivecor-turns-mobile-devices-into-low-cost-heart-monitors-raises-3-million/


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application we developed called CardioCare. This

application is designed to allow users to read, display and

upload an EKG to their clinicians office using a telemetry

wand placed over a patients pacemaker or defibrillator. It

also allows them to report heart failure related symptoms,

such as fatigue, shortness of breath, and fainting, calling

911 and clinician-enabled smartphone set-up.

Figure 2. CardioCare User

Figure 3. CardioCare User decides to check his EKG and

transmit to clinic while on vacation

Figure 4. CardioCare is loading on his iPhone

Figure 5. Simple easy-to-remember steps are always displayed

Figure 6. CardioCare reads, transmits and lets user know hes

successfully sent his EKG to his clinic


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Figure 7. CardioCare users can transmit symptomatic data

such as shortness of breath, dizziness and fatigue

Figure 8. Users can report light, moderate, severe or no

symptoms

Figure 9. Symptomatic data is sent directly to the clinic to

alert his physician in the event hes feeling ill

Figure 10. CardioCare provides users and their physicians a

sense of well being at home and on the road

CARDIOCARE ANNOTATED SCREENS

We later improved upon our concept by developing fullyannotated screens and detail for development.

Figure 11. Home Application Launch

Figure 12. EKG Start Menu


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Figure 13. EKG Reading

Figure 14. EKG Confirmation

Figure 15. Symptoms - Breath

Figure 16. Symptoms

Figure 17. Symptoms - Stairs

Figure 18. Symptoms - Faint

Figure 19. Symptoms - Confirmation

Figure 20. 911 Call Screen


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Figure 21. Settings

Please note that not all options are selectable so all

interactions may not be reflected when making selections

within the prototype. Please follow the link to view the

interactive prototype:

http://share.axure.com/N66X95/Home.html

EVALUATION

A small sample was used to step through tasks using the

mid-fidelity prototype. Participants accessed the application

at the above website and were asked to comment about

sending and EKG, entering symptoms, what they thought

the Settings and Call 911 buttons were for. The following

represents our observations and findings:

Sending an EKG and Symptoms

Users indicated theyd follow the instructions to plug in the

jack and to place the round wand over his heart to measurehis EKG. They said instructions were clear and easy to

understand. However, they felt symptoms should appear

first on the navigation bar, and then sending an EKG would

be next. However, unbeknownst to users who are not

required to send heart failure monitoring symptoms (this

disease state monitors weight, blood pressure and fatigue), a

cardiologist can read an EKG and determine the symptoms

a patient is feeling. Inputting symptomatic data is secondary

in the event of a life or death situation, and it is most

important to send the EKG as soon as possible.

Recommendations: Make the EKG start process more

prominent on the screen. To avoid patient confusion,

symptoms should only be present for monitoring heartfailure (not heart attack), and programmed to display / not

display in device under Settings category

Settings Button:

Users understood the meaning of the Settings button, and

that only clinicians should be allowed to modify these

settings. They felt that under settings, there should be the

doctors phone number, personal information, the type of

pacemaker, and also suggested there should be a calendar

function indicating these measurements should be taken on

a basis prescribed by the physician. Users also indicated it

would be very useful to show medications being taken,

indicating this is a comprehensive applications for

measuring heart complications, medications, and tests.

When asked why they thought the User ID and Password

was present under settings, the user said it was there so only

the doctor could make changes. He said your doctor would

have a prescribed regimen or protocols the user needed to

follow and wouldnt want the patient to be messing around

with the type of device or medications. This wouldnt be

something youd want the layman to be changing.

Recommendations: Consider adding a calendar function

and area for indicating medications, turning on and off

symptomatic reporting and transmission reminders.

Call 911 Button:

When asked how to make an emergency call, the user

correctly chose the button for Call 911. However, when

encountering a telephone keypad rather than seeing an

indication the phone was dialing, users felt that if the button

says Call 911, it should immediately call 911. Users

indicated there should also be a Call Doctor that both Call

911 and Call Doctor should be hot buttons. Users also felt

the Call 911 button should have a symbol more indicative

of an emergency, and not just a phone symbol.

Recommendation: Make the Call 911 immediately dial

911. Perhaps this can be stored as an auto dial in the app.Consider adding a Call Doctor button.

CONCLUSIONS

Based on our literature search, Smartphones and Tablet PCs

provide an opportunity to create and improve upon

traditional technology found in cardiac rhythm

management. mHealth devices can create mobile portable

platforms so physicians are no longer tied to power cords

and exam rooms. Additionally, using wireless technology

coupled with radio frequency (RF) allows clinicians to

move freely between exam rooms and patient bedsides.

Computer networking and todays improved telephony

communications coupled with the internet allows for

healthcare remote practice to take place, as long as patients

are observed while changes are made, ensuring no patient

harm is resulting due to the loss proximity between patient

and physician.


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