Screening of Patients With Suspected Heart Rhythm Disorder on Primary Health Care Level With the Use of Personal Digital ECG Sensor
Conditions: Cardiac Arrhythmia
Sponsor: Healthcare Center Murska Sobota

 
 
 
 
 
 
 
 
 
Screening of Patients With Suspected Heart Rhythm Disorder on 
Primary Health Care Level With the Use of Personal Digital ECG 
Sensor 
 
DEVELOPMENT OF A PROTOCOL FOR THE USE OF ECG SENSOR IN THE 
CARE OF PATIENTS AT THE PRIMARY HEALTH CARE LEVEL 
 
 
 
 
 
 
 
26. 06. 2016
Staša Vodicka, MD 
Health care center Murska Sobota 
Grajska ulica 24, 9000 Murska Sobota 
Slovenia 
 
 
 
 
 
 

 
 
1. PURPOSE, GOALS AND HYPOTHESES 
 
1.1.  Purpose 
The purpose of the study is to develop and validate a protocol for the use of the ECG sensor 
device to detect arrhythmias in the care of patients at the primary level and to show that the 
use of the device is safe and contributes to better and more economical treatment of the 
patient.  
 
1.2. 
Goals 
1. Develop and validate a protocol for the use of an ECG sensor device to detect 
arrhythmias in patients in a family medicine practice. 
2. Analyze the most common arrhythmias in patients with undiagnosed arrhythmias. 
3. Assess the quality and safe use of the ECG sensor device in the treatment of patients at 
the primary level with the help of qualitative indicators. 
4. Assess the economic efficiency of the new tool in treating patients at the primary 
level. 
 
4.3. 
Hypothesis 
1. It is possible to develop a validated protocol for the use of an ECG sensor device to 
detect arrhythmias in patients in a family medicine clinic. 
2. The most common arrhythmias in patients with undiagnosed arrhythmias are benign 
and do not require additional cardiac treatment. 
3. Patients and doctors are satisfied with the use of the ECG sensor device in the treatment 
of patients at the primary level, its use is safe. 
4. The use of an ECG sensor device reduces referrals to specialist cardiologists and 
additional diagnostics, thus reducing the cost of medical care. 
 
2. JUSTIFICATION 
2.1. Introdution 
Cardiovascular diseases are a great problem. In Europe, 50% of all deaths occur due to these 
diseases. (1) 
In 2016, cardiovascular diseases were a cause of 40% of all deaths in Slovenia. This makes up 
47% of women’s deaths and 32% of those of men. From 2009 until present, cardiovascular 

 
 
diseases are the second most common cause of death, right after neoplasms. When talking about 
cardiac diseases, the three main causes of death are acute myocardial infarction, arrhythmia and 
heart failure. The age-standardized mortality rate in Slovenia had surpassed European average 
in the eighties and nineties of the previous century. However, this difference is decreasing since 
2000 and is getting closer and closer to the European average. (2) 
Considering the causes of primary care visits, cardiac diseases represent 5.60% of the total 
number of visits, i.e. 283,143 medical check-ups. Cardiac diseases are the seventh most 
common cause for primary care visits. (3) 
This data shows us that the medical service expenses, especially those that concern 
cardiovascular diseases, are high. Arrhythmia affects millions of people each year. Some types 
of arrhythmia are hard to diagnose as they occur sporadically, whereas others do not present 
any danger for health (e.g. supraventricular extrasystole (SVES) or paroxysmal 
supraventricular tachycardia (PSVT). Nevertheless, there are still some dangerous arrhythmia, 
such as ventricular tachycardia (VT), that can affect human health. (4, 5) 
Despite the progress in medicine, doctors are still using the common methods, such as referring 
patients to a cardiologist and/or recording an ECG, when treating their patients. The rest of the 
methods, e.g. an ultrasound, an MRI/CT scan or a scintigraphy require specialists’ time, are 
very expensive and the waiting time is long. Considering the dimension and the gravity of the 
problem, the need for cheaper, yet reliable continuous monitoring of cardiovascular system has 
occurred. 
The use of the so-called eHealth (telehealth), supported by micro- or nanoelectromechanical 
systems, is increasing in the last years. Here we are talking about for example low-cost sensors 
that trace various physiological parameters that are connected to human health, such as body 
temperature, heartbeat and blood pressure. (6) 
Digital technology is becoming a more and more important tool for a family doctor, especially 
in communication with patients and colleagues or specialists, with the presumption that 
connections in telecommunications network are secure enough for the exchange of delicate 
data. (7) 
Telemedicine is a concept that describes telecommunication and information technology with 
the purpose of providing medical help from a distance. It enables medical service with the help 
of information and communications technology when the healthcare workforce and patients are 
not in the same place geographically. It helps to reduce the distance and improves access to 
medical service that is not available in distant rural areas. The early form of telemedicine 

 
 
included the telephone and the radio, while in modern times video calls, progressive diagnostic 
methods available in various mobile apps and telemedical devices became more and more 
popular. (8) 
Secure data and text, sound, image or other information transmission has to be assured for the 
performance. With the help of these data, a physician can perform or control the course of 
treatment, prevent deterioration and make diagnoses. (9) 
Telecardiology is a specialized version of telemedicine, where the ECG records are being 
forwarded via telephone or wireless connection. (10) With its use, the quality, quickness and 
cost-effectiveness of treating heart patients on primary level can be improved.  
The purpose of this article is, with the help of already published literature, to evaluate the state 
of the activity in telemedicine on primary level in Slovenia as well as in the world. 
2.2. Study design  
In collaboration with medical experts, the Jožef Stefan Institute of Slovenia developed a 
personal portable ECG sensor that works in conjunction with a smartphone. The Personal 
Digital Mobile Body Sensor is listed in the medical device category, has the status of a medical 
device with all necessary certifications, and is owned by Savvy (Figure 1). It includes a personal 
sensor, ECG electrode kit, MobECG mobile application (Figure 2), and computer program 
called VisECG (Figure 3), which is currently available for Android only. The ECG sensor 
consists of two electrodes, which are placed 8.5 cm apart, and measures the potential between 
these two closely placed body-surface electrodes. The gadget weighs 21 g and has several 
possible positions of placement. The measurement is transmitted via Bluetooth connection to a 
smartphone, where the device is paired and managed via the MobECG mobile application. 
 
3. 
Figure 1. Personal Digital Mobile Body Sensor by Savvy 
Initially, personal and other necessary information are entered into the smartphone application; 
then, the user can forget that he or she is wearing the device. The application works reliably in 
the background, even when using the phone for calls or other applications. If desired, the user 
can monitor the heart rate on the meter display with a curve and calculate it on an ongoing basis. 

 
 
Finally, the measurements are collected on the phone and can be transmitted to the physician in 
two ways: (1) pressing the button, the user can prepare a PDF report and send it to the 
physician's e-mail address or (2) transfer the data via USB cable to the physician's computer, 
where he or she can closely monitor the entire recording using VisECG. The first method is 
useful in the case of a severe disorder in which it is necessary to inform the physician. However, 
it is still related to the availability and responsiveness of the physician. 
 
Figure 2. Application MobECG on a smartphone 
 
Figure 3. Application VisECG on a computer 
When reading the recording, one should remember that it is not any standard lead typically used 
in a Holter monitor and that it is a single-channel measurement that is performed live on a 
patient moving and performing daily activities. The recordings can show different disorders but 

 
 
need to be evaluated so that artefacts can be distinguished from the actual disturbance of the 
rhythm. VisECG enables us to review and accurately analyze the recording and produce a report 
that can be submitted to physicians of other specialities for consultation or delivered to the 
patient and his or her physician as a measurement result. Given that the measurement is only a 
single channel, we can estimate the frequency and possible disturbances of rhythm but not 
ischemia. 
2.1. 
Cost-effectiveness assessment 
The assessment of economic efficiency is divided into two groups, regardless of the area under 
consideration. We first encounter input and output, which can be described as costs and 
consequences. Second, the assessment of economy is a consequence of choice. Our resources 
are not unlimited and in order to achieve the best possible output, it is necessary to make a 
choice. 
Over the past 20 years, 2 factors have significantly influenced the assessment of cost-
effectiveness in medicine; first, increased pressure on the health system to be effective both 
clinically and in cost control; therefore, decision-making processes have been developed that 
result in better cost-effectiveness results. 
 
3. RELEVANCE OF THE SELECTED TOPIC 
At the family doctor's office, patients with chest pain are frequent visitors and the use of an 
ECG recording device is a basic aid in their treatment. 
The problem with using an ECG is that there are often nonspecific changes that less skilled 
doctors are not always able to interpret well and therefore refer the patient for treatment either 
to a hospital in an emergency room or to a cardiologist. An even bigger problem is the 
misinterpreted ECG result as normal in patients who may be life-threatening. So we face a 
double problem: the unnecessary sending of healthy patients for additional examinations and 
the problem of not recognizing the critical situation. It is very important to have enough 
diagnostic tools available that can be used to treat patients in the family doctor’s office. 
Telemedicine offers us a new method in treating patients with suspected or confirmed heart 
disease. It is a direct link between the patient and the family doctor, in order to obtain a correct 
diagnosis more quickly and to refer fewer patients to further unnecessary examinations.  
Studies have shown that telecardiology can be used to treat patients with specific heart disease 
(5), also helps better family physician decision-making (6), and reduces unnecessary 

 
 
hospitalizations without reducing appropriate referral of patients with life-threatening 
conditions. (7) 
 
3.1. 
A contribution to science 
There has been no protocol found in the literature for the use of the ECG sensor device in the 
care of patients at the primary level, nor is there any research that would confirm its safe and 
effective use at the primary level. An important contribution will also be the assessment of the 
professional effectiveness of the introduction of a new method at the primary level of medical 
treatment. 
 
4. STUDY DESIGN, PARTICIPANTS, METHODS 
4.1. 
Study design 
The research will be quantitative scientific methodologies. It will be a prospective descriptive 
study. A test and control group will be formed for the study. 
4.2. 
Participants 
The observed units will be patients in the family doctor's office with a history of suspected 
arrhythmia, but without a previously diagnosed arrhythmia for which his treating physician will 
decide that despite all diagnostic procedures it is not possible to establish an arrhythmia, but he 
is still suspected of le-to. The sample will include 400 patients aged 18 to 99 years and their 
doctors, 200 of whom will be included in the test group and 200 in the control group. 
4.3. 
Methods 
4.3.1. The course of the research 
The research will take place on two levels. The first level will cover patients and the second 
their doctors. The research will last 24 months, the final phase will last one month. 
The first level of the study will cover patients with a history of suspected arrhythmia, but 
without a previously diagnosed arrhythmia. A 12-channel ECG will be recorded for each 
patient first, and if I find a rhythm disorder at that time, the patient is treated according to the 
guidelines and is not included in the study. However, if the diagnosis of arrhythmia cannot be 
made, the patient is included in the study. In the test or. in the control group patients will be 
included in order of the visit: the first patient is included in the test group, the next in the 
control group, the next in the test group, etc. In the test group, the patient receives an ECG 
sensor, which is installed by a healthcare professional and worn for 3 days. The measurement 
is then transferred to the computer's memory. After 5 to 10 days, the same patient undergoes a 

 
 
check-up at the chosen doctor, where he decides to take further action in the event of a 
recorded arrhythmia. If there is no arrhythmia on the recording, the patient can repeat the 
whole procedure again, but not more than three times. At the time of placement, the patient 
receives a questionnaire where he can write down his feelings and give an opinion on the 
quality and usefulness of the examination. Patients in the control group receive a 
questionnaire and report to the control of the chosen doctor in 5 to 10 days. 
The second level of the survey will include physicians of referred patients who will fill in a 
questionnaire about the patient at the time of referral, control in 5 to 10 days and in 3 months 
and a questionnaire for physicians, where he will give an opinion on the quality and 
usefulness of the examination. 
Based on quality indicators, we will assess the number of referrals, measure the frequency of 
anxiety and palpitations in patients, assess the potential impact on reducing waiting times, and 
use a patient and physician satisfaction questionnaire. 
As far as the economic aspect is concerned, we will initially estimate the cost of the test and 
control group, monitor it for 2 years and evaluate it at the end of the research using cost 
indicators that we will set for myself. Based on this assessment, we will try to establish a cost-
effectiveness model. 
We will assess the safety of using the device with a questionnaire about the patient's problems 
using the device and the method of examination (installation, handling of the phone, 
detachment, contact of the device with water). 
4.3.2. Instrument description 
V raziskavi bom uporabila naslednje instrumente: 
a. ECG sensor 
b. ECG sensor record 
c. Structured questionnaire for patients  
d. Structured questionnaire for doctors: (so far summarized after the pilot study of ZD 
Ljubljana: Use of a personal meter in the family doctor's office) 
i. doctor's questionnaire about the patient; 
ii. doctor's questionnaire about doctor and patient. 
 
Ad a. With the help of an ECG sensor reading, we will obtain data on the heart rhythm of 
200 patients and on possible arrhythmias. 
 

 
 
2. Ad b. Using a structured questionnaire for 400 patients, we will obtain the following 
data: 
 
1. Demographics (gender, age, education, employment) 
2. Reason for coming to the doctor 
3. Opinion on the usability and comfort of the installed sensor 
4. Opinions and experiences on this method of diagnostics. 
 
Ad c. With the help of a structured questionnaire for doctors, we will obtain the following 
information: 
Ad i .: doctor's questionnaire about the patient, which is divided into 3 parts and the doctor 
enters data about the patient before placement - part 1, at the first control - part 2 and at the 
second control - part 3. 
Part 1: Chronic Patient Illness, Regular Therapy, Smoking Status, Alcohol Drinking, 
Blood Pressure, BMI, Cause of ECG Sensor Installation, Working Diagnosis, and 
Additional Investigations. 
Part 2: Diagnosis based on reading, action 
Part 3: Diagnoses and additional investigations, referrals or medications 
Ad ii .: doctor's questionnaire about the doctor, where the doctor enters the following 
information about himself. 
1. Demographic data (gender, age, years of service, specialization) 
2. Opinion on the usability and comfort of the installed sensor 
3. Opinions and experiences on this method of diagnostics. 
 
5. ANALISYS 
Analysis a: When reading ECG recordings, we will obtain data on the patient's basic rhythm, 
average heart rate, whether the day-night rhythm is maintained, data on the frequency and 
type of SVES (supraventricular extrasystole) and VES (ventricular extrasystole) and possible 
arrhythmias. We will use univariate analysis in this. 
By comparing the records in the patient's diaries and the recording, we will get information on 
whether the patient is just feeling a rhythm disorder or whether it is an actual disorder. We 
assume that when patients feel the disorder they will actually have a rhythm disorder, that the 
difference between these groups of patients will be statistically significant, for this we will use 
Pearson's Hi-square test (or correction for smaller samples - Fisher's exact test). 

 
 
 
Analysis b: When processing patient questionnaire data, we will compare the test with the 
control group. To compare each factor between the groups, we will use the Mann-Whitney 
test for independent samples or the chi-square test (depending on whether the factor is 
categorical or numerical - Likert scale). 
 
Analysis c: When processing the Structured questionnaire for doctors questionnaire data, we 
will compare the test with the control group. To compare each factor between the groups, we 
will use the Mann-Whitney test for independent samples or the chi-square test (depending on 
whether the factor is categorical or numerical - Likert scale). 
We will use univariate analysis when processing the questionnaire data. 
 
Numerical variables will be expressed as mean ± and range and compared using the t-test or 
Mann-Whitney test, as appropriate. Categorical variables will be presented as percentages or 
frequencies, and the differences were compared using Pearson's chi-square test. A P-value ≤ 
0.05 was considered statistically significant in all tests. All analyses will be performed using 
the SPSS® Statistical Program version 26 (SPSS Inc., Chicago, IL, USA) for Windows®. 
 
 
6. EXPECTED RESULTS 
We expect to describe and develop and validate a protocol for the use of the ECG sensor in 
primary care patients, which would be a safe, reliable and high-quality device at work, with the 
help of the ECG sensor device and its readings, and completed questionnaires by patients and 
doctors. primary care physician in treating a patient with suspected cardiac arrhythmia. We will 
also assess the financial benefit of introducing a new method at the primary level. 
 
7. APPROVAL OF THE MEDICAL ETHICS COMMISSION 
Patients who will meet our criteria will be invited to participate in a study that was approved 
by the Ethics Committee of the Republic of Slovenia (number 0120-299/2017-7,), and written 
informed consent will confirm their participation. The study will be conducted in accordance 
with The Code of Ethics of the World Medical Association (Declaration of Helsinki). 

 
 
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