mHealth for Cardiac Patients Telemonitoring and Integrated Care Zviad Kirtava1,2, Tea Gegenava1,2, Maka Gegenava1,2

1 – Partners for Health NGO, 2 – Tbilisi State Medical University, Dept of Internal Medicine zkirtava@nilc.org.ge

Abstract — In the majority of developing economies there has been limitation to rapid growth of technology-rich and expensive broadband telecommunication infrastructure (e.g. optical fiber networks), which is prerequisite of e-Health. However, along with the emergence of broadband mobile communication networks, mHealth seems advantageous and cost-efficient mode of e-Health in those countries, likewise Georgia. The first mHealth project in Georgia on m-Telemonitoring (MTM-1) of Cardiac arrhythmia - 54 patients with main medical results, Quality of Service (QoS), Quality of Experience (QoE), cost-efficiency and remaining challenges - is presented, as well as the outline of its continuation - MTM-2 project, which aims improvement of decision making for emergency cardiac patients and usage of mHealth applications for integrated care provision in remote regions of Georgia.

Keywords — mHealth, e-Health,

telecardiology, telemedicine, m-telemonitoring, arrhythmia, coronary artery disease, integrated care, Georgia (Rep. of) I. INTRODUCTION For last decade World Health Organization (WHO) puts more and more emphasis on e-Health (Electronic Health, Telehealth) – or “Health realized through Information and Communication Technologies (ICT)”, as one of the potential and powerful solution to dealing with existing challenges of healthcare services’ disparities globally and locally and as a main tool promoting integrated and efficient patient-centered healthcare. e-Health encompasses a range of services or systems that are on the edge of medicine/healthcare and ICT, including (but not limited to): Health Management Information Systems (HMIS), Electronic Medical Records (EMR) and e-Registries; telemedicine; e-Learning; consumer health informatics; health knowledge management; mHealth [1-2]. Telemedicine is used when the patient is far from qualified medical personnel and transportation issue must be decided quickly. E.g., healthcare in mountainous regions (especially in snowy winters) and other hard-to-reach areas. Telemonitoring (remote monitoring) regards the situations when people with certain, potentially life-threatening risks are outdoor (tour, picnic), or a person with a serious disease (e.g., myocardial infarction and/or arrhythmia) needs case management either at pre-hospital stage, or after being discharged from the hospital, when

deterioration of condition cannot be excluded and monitoring is desirable. For different groups of patients (lonely mothers, patients with dementia or arthritis, etc.) m-telemonitoring is certainly more comfortable, as concomitant life-threatening conditions can be controlled at homes [2]. As cardiovascular diseases represent one of the leading morbidity and, especially, mortality cause throughout the world [4], telemonitoring of cardiac patients is one of the important parts of e-Health and mHealth [5,6]. WHO’s notion of integrated healthcare carries the promise of cost containment through shortening of hospital stay and reduction of inappropriate hospitalizations and admissions to long-term care, at the same time creating conditions for seamless and timely referral of a patient from primary healthcare (PHC) system to secondary or tertiary level hospital whenever needed [1]. Integrated healthcare is based on continuity of care, which is often subdivided in 4 components: 1. Continuity of information (through electronic medical records), 2. Primary-Secondary-Tertiary care interaction (vertical integration), 3. Multidisciplinary teams approach (horizontal integration), 4. Provider continuity. All these can be better realized with the emergence and implementation of e-Health [1,3]. mHealth (mobile health, m-telemedicine) represents an important recent sub-segment of e-Health and a rapidly growing branch of telemedicine, which covers the practice of medical and public health, supported by mobile devices, such as mobile phones and PDAs, for health services and information [2]. In process of mHealth broadband mobile connectivity (GPRS, 3G, 4G) is used as communication means to transfer data between medical professionals and patients. Thanks to growing spreading of cell phones in developing economies (e.g., mobile penetration in Georgia has grown from 19% in 2004 to 100% in 2012, www.gncc.ge), increase in coverage zones (>98% of populated territory of Georgia, www.gncc.ge), bandwidth rich applications, technical and financial affordability of broadband applications, – mHealth is evolving as an advantageous and cost-effective tool, especially in emerging economies, where limitation to rapid growth of technology-rich and expensive infrastructure for years was a main barrier to telemedicine development, whereas there are already existing mobile communication networks now. Broadband mobile telemonitoring can be provided from anywhere – not only from fiber-optic cable-connected top-notch hospitals, but also from patient’s home, workplace or from any outdoor location, street, or place of accident [1-3].

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One of the most important elements of e-Health/mHealth service regards the best possible ICT support, which would enable better Quality of Service (QoS). However, user perception and user acceptance, defined as Quality of Experience (QoE), seem to be an even more important aspect and determinant of e-Health/mHealth development [7]. Eventually both technology adjustability and QoE would define exact growth of m-Health, which bears an impressive business opportunity by different market researches [3,8]. So far, Health Research Institute (HRI) estimates the annual consumer market for remote/mobile monitoring devices to be $7.7 billion to $43 billion [8]. In this paper we present data about feasibility of m-Telemonitoring for Cardiac Arrhythmia (CArr) patients in Georgia (MTM-1 project, 2010), typical most useful scenarios of m-telemonitoring, some data on Quality of Service (QoS) and Quality of Experience (QoE), cost efficiency of arrhythmia m-Health monitoring, discuss advantages/challenges of m-telemonitoring for arrhythmia patients and marketing challenges. We will also shortly outline our recent grant project application – MTM-2 (2013-2015) - mHealth based telemonitoring for improving decision-making and integrated care for remote cardiac patients: Pilot study for Adjara and Kakheti regions in Georgia. II. CARDIAC ARRHYTHMIA M-TELEMONITORING (MTM-1): A classical example demonstrating the impact of telemedicine on diagnosis and treatment is the event recording of arrhythmias. Monitoring of arrhythmias on an ambulant basis seems to be cost effective and a promising concept for homecare and rehabilitation. Arrhythmia telemonitoring allows the patient to move free on the ward without staying in bed. The advantages for physicians and medical staff is the combined monitoring of different patients, an alarm management for different parameters (heart rate, blood pressure, respiration and oxygen saturation), online diagnostics of arrhythmias and post procedural supervision. For out-of-hospital monitoring of cardiovascular patients loop recorders and event recorders are available. The use of event recorders with a direct transmission of ECG’s can reduce the time of admission to hospital for risk groups, particularly – for arrhythmia patients, facilitate the diagnosis on an ambulant basis and reduce costs [5,6,9]. Material and Methods: During 06/2010-12/2012, we investigated 54 outpatients with different types of arrhythmia (M/F=32/22, age – 12-80 y), among them 10 patients with concomitant epilepsy, 6 patients after radiofrequency catheter ablation(RFA), 4 patients after coronary artery bypass graft surgery (CABG) and 10 patients with unexplained syncope. Control group - 7 clinically healthy sportsmen (all – men, 15-17 y), during 30 min veloergometer stress-test). Selection of control group aimed to test mHealth monitoring during vigorous physical exercise. Investigations were made by 3-lead ECG Loop Recorder (Vitaphone BT 3300, Vitasystems GmbH, Germany) in automatic recording/transmitting mode, using

special LRMA software (MDT s.r.o., Czech Republic) pre-recorded at Nokia 6730 (Symbian) phone. Since 2012 we also use Huawei U8180 IDEOS X1(Android) phone. Arrhythmia m-telemonitoring process chain is presented at Fig. 1:

Fig.1: Communication means used in MTM-1 project

The memory of the Vitaphone 3300 BT is large enough for the continuous recording of 40 minutes of a 3-channel ECG. The oldest ECG data are overwritten (loop function). Intelligent LRMA software automatically detects and records rhythm disturbance events by recognizing R-R interval irregularities. Then loop recorder transfers event ECGs through Bluetooth to mobile phone. The recorder and mobile telephone can be in up to 10 meters range from each other to secure Bluetooth wireless transfer. LRMA software then allows phone to send data by 3G communication to Tele-ECG REMOS server in Chemnitz (Germany). With a low-level signal the ECG recorder interacts with phone, which with the same low-level beep confirms sending-receiving of recorded ECG. As it is done, the REMOS web-server, as well as doctor’s e-mail gets new mail with .pdf type ECG file. That provides ubiquitous service provision (anywhere anytime), besides, all ECGs could be transferred and safely stored for patient data dynamics review. In case of electrode detachment or low battery the loop recorder issues high level pitch signal (3 beeps). If the fault is not recovered the equipment is switched off in two minutes. Results: Arrhythmias were registered/monitored during 7-68 hours of observation. Number of automatically recorded ECG events varied between 3 and 170 per observation or 0.4-10.7 hourly. Minor artifacts have been recorded as mainly first minutes of recording (in 9%) or during vigorous physical exercise (around 12%, mainly - in sportsmen group). Cases of sinus brady- and tachyarrhythmia, sick sinus syndrome, atrial fibrillation (AF), supraventricular tachycardia (SVT), supraventricular premature complexes (SVPCs) and ventricular premature complexes (VPCs) have been correctly recognized by automatic recognition

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software and recorded. There have been 2 patients (3.7%) when m-telemonitoring couldn’t reveal previously diagnosed arrhythmia (SVT or VPCs), but that could be due to transitory character of those abnormalities. On the other hand in 7 patients (13%) the diagnosis was modified/clarified based on m-telemonitoring findings. 52% of arrhythmia episodes were asymptomatic. Arrhythmia relapse (SVT or SVPCs) was detected in n=3 (from n=6) patients who underwent radiofrequency catheter ablation, and mostly they were asymptomatic. Asymptomatic episodes of VPCs were often detected in patients who underwent CABG surgery. From n=10 patients with epilepsy we discovered n=3 patients with supraventricular tachycardia (SVT) and n=2 patients with sinus tachycardia. Among n=10 patients with unexplained syncope, we revealed n=2 patients with sinus tachycardia, n=2 patients with SVT and n=1 patient with sick-sinus syndrome. III. TELEMONITORING SCENARIOS Following real-case scenarios demonstrate benefits of mHealth telemonitoring for cardiac arrhythmia patients: Scenario #1: Natia is 32 year old young mother of 2.5-year old twin boys. Being medical doctor herself she is not working currently with limited chance both to find the job and also to have somebody to provide care for kids, whom she lovely calls “bandits”. During last year she often had heart palpitation and dizziness, which lasts around 30-120 sec and then stops, sometimes, a feeling of strong heartbeats, after which “the heart stops”. She made regular ECG twice, which has shown no abnormalities. She was advised to have inpatient care at cardiac ward, but that was expensive, besides she couldn’t leave the kids. We have discovered by mHealth telemonitoring (45 hours observation) that Natia has episodes of Sinus Tachycardia and non-frequent SVPCs, mainly during night times or during home work (laundry). She was given medication and was advised to check thyroid hormones (which proved to be normal). She was very happy by having chance of m-telemonitoring and said she was always worried that she could have had something really serious, but was unable to go to the hospital. It was very convenient to be at home with kids, walking them around and doing usual work and at the same time being confident that her health status is being observed – Natia said after investigation. #2: Natela is a 77 year old pensioner, on post-ER rehab at home after strong 3rd episode of Ischemic stroke for last 1.5 years. As previous treatment with Aspirin proved ineffective, now on Fraxiparin and then Warfarin anticoagulation treatment. She has speech impairment and left-hand motor deficiency, uses notepad for communication with the hired caregiver. With last two stroke episodes she had persistent atrial fibrillation (AF), which was transformed by Amiodarone treatment back to sinus rhythm (SR). At 2nd day of Warfarin she again developed AF and as cardioversion invasive treatment was dangerous at this stage with risk of recurrent emboli and stroke, we started m-telemonitoring

which has shown tachysystolic AF with risk or paroxysmal flatter. Beta-blocker treatment was started and we carefully monitored her heart rate going down from avg. 136 to avg. 56. After that dosage of b-blocker was halved and after 2 weeks SR was restored. In this situation it was risky to move patient back to hospital, but she certainly needed an extended monitoring. Thorough m-telemonitoring was investigation of choice. Scenario #3: Zviad is 12 year old boy from Western Georgian village. He has epilepsy and due to nodular tachycardia (NT) has passed radiofrequency catheter ablation 2 years ago. Recently he has started to have episodes of palpitation and chest pain again. m-telemonitoring has revealed recidive of NT, which means he either needs to pass RFA again, or to reconsider his main treatment (antiepileptic drugs are often causing CArr). This was one of the first m-telemonitoring in Georgian rural district. Side Effects: 49 patients have passed investigation without side effects, whilst in 5 cases (4 – women, 1 - man) light insomnia and nervousness (expecting signal during night) was reported. In two patients with neurosis (both – elderly men, 1 – with concomitant epilepsy) we had to stop the investigation due to patients’ anxiety/agitation related with technology and/or idea of constant monitoring. Technical Faults: Bluetooth miscommunication between ECG loop recorder and mobile phone - only 19 such events out of 2751 events (0.7%). Minor artifacts have been recorded mainly at first minutes of recording (in 9%) or during vigorous physical exercise (around 12%, mainly - in sportsmen group). Low voltage in one of 3 recorded channels (mainly during night-time, in 3 patients - <6%) – presumably due to loose contact of electrode during sleep. Stop of recording due to electrode dis-contact has happened in 6 patients (11%, mainly in night-time 4/6). Loop recorder cannot register all events of arrhythmia, because after recording (usual mode - 25 sec before and 15 sec after the event) the equipment is “deaf” for another 40 sec, therefore it can only register maximum 30-40 events hourly, but that is acceptable. However, in addition to that we have noted that sometimes the software misses the event, which is then recorded in the next “pre-event” period. We have noted that approximately in 10% of cases. The event recognition rate is even lower in AF which is a situation when R-R interval is constantly changing and virtually all episodes could be regarded as “events”. But the software has problems to assess the “average” R-R interval due to that. Quality of Service (QoS) data: Total 2751 sessions were recorded, 72% of which in 2010. Average traffic per session – 12.65 Kb (11.6-13.7). The whole “cycle” of event recording-transfer to server-reflection on web-server/transfer to physician’s e-mail (we used corporate Gmail) takes 47-51 sec. Such delay is acceptable. Of this cycle recording was taking 16-17 sec, authorization/sending (including both Bluetooth and 3G/3.5G communication) – 14-15 sec, and back-route of pdf file report – 17-18 sec. According to MagtiCom technical service 3G/3.5G communication including authorization with server required 5-6 sec, of which greater part (app. 80%-90%) was authorization part. As the sent information was very small in size – 11-13 Kb, the

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significant difference in throughput between various types of connectivity and in various parts of Tbilisi (GPRS/EDGE – 30-250 kb/s and HSDPA – 0.8-6.4 Mb/s) resulted in nearly no difference for traffic delay. The report from Remos server in pdf file format was about 10 times larger than sent information – 120-138 Kb, so the main challenges and delays happened at 3rd part of the route – to physician’s laptop, or particularly – Smartphone and that was mainly pending on type of the OS (e.g. Android 2.2 slower than Android 4.0) or hardware (e.g. Motorola Milestone significantly worse than recent iPhone, HTC, Sony Xperia or Samsung Galaxy). Quality of Experience (QoE): Survey results (by 26 patients and 7 doctors) are presented in Table 1 & 2:

Cost Efficiency: is presented in Table 3:

MTM-1 project commercialization and marketing Challenges We have planned to have cardiac arrhythmia m-Telemonitoring as commercial service since 2011. However, due to hospital privatization program of previous government and drastic changes in TSMU clinical bases we had to change our location since 2011 three times. Currently we have the service available at three private clinics and plan major change in marketing and sustainability since November of 2013 when our team moves to Chapidze Heart Center, a pioneer of invasive cardiology in Georgia (www.chapidze.ge). IV. MTM-2 PROJECT - M-TELEMONITORING FOR IMPROVING DECISION MAKING AND INTEGRATED CARE FOR REMOTE CARDIAC PATIENTS There is significant imbalance in institutional and human resources of healthcare between Tbilisi and regions. According to governmental decision arrangement of different capacity hospitals in regions and districts will elevate institutional imbalance by end of 2013, but imbalance in human resources may still exist for years. The project aims to develop guidelines and assess cost-efficiency of the model for integrated care provision to cardiac patients in two regions of Georgia based on their m-telemonitoring, teleconsultation, evidenced-based decision-making and tertiary level/interventional cardiology support either at nearest certified point-of-care or – at central university clinics in Tbilisi with organized transportation by the State Referral Service. Three major life-threatening cardiac conditions are chosen for mHealth monitoring: CAD – when potential Coronary Angioplasty CA or CABG surgical interventions is thought, CArr – with vision of potential Radiofrequency Catheter Ablation (RFA); and AH – for administering AH Individualized Treatment Schemes (HITS). MTM-2 Project objectives:

- m-telemonitoring of 120 patients with CAD, CArr and AH (both inpatients and outpatients) in selected regional/district hospitals under the supervision of contracted by project research-associates;

- Based on pre-validated guidelines for cardiac patients telemonitoring selection and developed schemes for risk stratification and inclusion/exclusion criteria to screen those patients with the above-mentioned conditions which require emergency interventions (CA/CABG for CAD, RFA for CArr or HITS for AH).

- To determine the site of intervention and emergency transportation to specialized tertiary care unit;

- To re-assess those patients with CAD, CArr and AH which undergone invasive/specialized treatment;

- Estimation of cost benefit of m-telemonitoring of cardiac patients and development of National Guideline.

V. DISCUSSION New Strategy of Government of Georgia towards building modern and efficient Health Management Information

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System (HMIS) “Healthy Georgia – Connected to You!” - was produced and presented (2011) with support from the US AID. This vision provides the framework within which various entities (both private and public) will operate in future across the health sector. Electronic Health Management Information System (HMIS) will connect all medical and healthcare provide institution, health insurance companies, laboratories and pharmaceutical companies along with regulatory bodies to improve communication, data reliability and integrated care for achieving the ultimate goal of patient-centered healthcare – better monitoring, better management, better safety and better outcome, thus creating cost-efficient, high-quality healthcare system accessible for every member of the society. mHealth solutions will greatly enhance and ease implementation of this strategy. mHealth creates a win-win situation for the patient, doctor (GP and remote specialist), hospital and insurance. A patient is reassured that his/her health is in good hands, by being silently monitored all the time and transferred to high-tech clinic in case of emergency intervention decided appropriate. Doctors can pursue other activities or manage different patients whilst still can be easily reached anywhere/anytime and providing better advice and integrated care with access to electronic medical records. Hospitals can discharge patients early, or transfer patient to more specialized/high-tech university clinic, if needed. And insurance companies have better patient safety with improved outcome and patient satisfaction, and do save funds with reduced number of hospitalizations, shorter in-hospital staying and lower-cost m-telemonitoring at home. The post-hospital use of m-telemonitoring significantly shortens in-patient hospitalizations for purposes of clinical cardiology diagnostics and treatment. However, there are some pitfalls – some patients may feel discomfort with complexity of telemonitoring technology self-management [10]. We consider that due to substantial cost of equipment, limitations of existing insurance schemes and yet very few mHealth systems enrolled in Georgia, operation cost might be economically non-viable for long-term (> 1 week) m-telemonitoring scenarios. However, deployment and coordinated management of multiple mHealth systems, as well as employment of telecardiological functional diagnosis, in pre- and post-hospital care opens new economic horizons: therapy, based on its data and findings, quite often brings tangible rewards later on. VI. CONCLUSIONS: 1. Our study confirmed that mHealth represents feasible methodology to monitor cardiac arrhythmia in outpatients in Georgia, promoting earlier discharge of non-life-threatening cases, improving patients’ comfort of life and increasing their mobility with enhanced safety. 2. According to QoE survey results both patients and physicians assessed arrhythmia m-telemonitoring as highly satisfactory, convenient, acceptably priced and easy to use service, which was perceived by great majority of them

better than expected. Doctors also noted substantial preference of m-telemonitoring vs. regular ECG, whilst patients specifically noted comfort of life and easiness of service. However, few elderly patients disliked technology, night time alarms and/or idea or constant monitoring. 3. The service of m-telemonitoring could improve many aspects of systems’ interrelationship – between insurance, physicians, inpatient and outpatient care-provider institutions, and – the patient. Future studies are planned for service enhancement for different groups of patients (elderly patients, patients with limited mobility) and for secondary prevention. 4. Finally, in remote areas patients monitoring by mHealth methodology would improve quality of care by timely provision of second opinion in cases, when local expertise is not sufficient, and by establishing protocols and routes for patient emergency evacuation and timely provision of integrated care in those cases, when invasive cardiology solutions are thought as appropriate choice.

ACKNOWLEDGMENTS: - MTM-1 project (2010) was funded by joint grant from CRDF-

Global (www.crdfglobal.org), GRDF (www.grdf.ge) and Georgian Rustaveli NSF (www.rustaveli.org.ge).

- MTM-2 project (2013-15) has been presented to Georgian NSF (www.rustaveli.org.ge). 1st stage selection passed, final decision – Dec 2013.

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