676 Zdrav Vestn | november – december 2016 | Letnik 85 JaVno ZdraVstVo (VarstVo pri deLu) Javno zdravstvo (varstvo pri delu)Klinični primer 1 MKS Elektronski sistemi d.o.o., Ljubljana 2 Splošna bolnišnica Slovenj Gradec 3 Zdravstveni dom Ravne Korespondenca/ Correspondence: drago rudel, e: drago.rudel@mks.si Ključne besede: telemedicina na domu; sladkorna bolezen tipa 2; kronično srčno popuščanje; opolnomočenje bolnika Key words: home telemedicine; diabetes mellitus type 2; chronic heart failure; patient empowerment Citirajte kot/Cite as: Zdrav Vestn. 2016; 85:676–85. prispelo: 20. 5. 2016 sprejeto: 6. 11. 2016 Telemedicine support to patients with chronic diseases for better long-term control at home Izvajanje telemedicinske podpore bolnikom v domačem okolju za boljše obvladovanje kronične bolezni drago rudel,1 Cirila slemenik-pušnik2, Metka epšek-Lenart,2 stanislav pušnik,3 Zdravko Balorda,1 Janez Lavre2 Abstract Authors in many scientific publications suggest that the telemonitoring of health parameters is a useful tool for supporting patients with long-term conditions staying at home and their self-manage- ment of the disease. Those patients are likely to benefit from timely and adequate response to dete- riorated conditions detected by the telemedicine system. Almost all of the studies state that telemedi- cine provided as telemonitoring can be an effective add-on tool in the hands of patients and medical experts for the self-management of patients with, for example, heart failure or diabetes. In this paper the principles of patient telemonitoring are presented as applied within a telemedicine service pro- vided by the Centre for Telehealth (CEZAR) at the General Hospital Slovenj Gradec (Slovenia). The centre supports patients with diabetes mellitus type 2 and/or with chronic congestive heart failure. The service was set-up in 2014 as part of a European project called UNITED4HEALTH. Since then over 550 patients from the Carinthia and Saleška regions (Slovenia) have been receiving telemedi- cine support for more than two years. The clinical outcomes of the telemedicine service published elsewhere prove that the selected telemedicine service model is adequate and the implemented tech- nological solution is acceptable for all service users: the patients and the clinicians. Izvleček Avtorji številnih znanstvenih objav navajajo, da je spremljanje parametrov zdravja na daljavo upo- rabno orodje pri podpori kroničnim bolnikom, ki sami, ob ustrezni medicinski podpori, skrbijo za svojo bolezen. Tem bolnikom pravočasen odziv in ukrepanje ob poslabšanju bolezni, ki ga omogoča telemedicinska storitev, izboljša izid zdravljenja. Rezultati vseh tovrstnih raziskav nakazujejo, da je lahko telemedicinska storitev v obliki spremljanja parametrov zdravja na daljavo (telemonitoring) učinkovito dodatno orodje v rokah bolnika in zdravstvenih oz. medicinskih strokovnjakov pri sa- mooskrbi sladkorne bolezni in/ali srčnih bolezni. V članku predstavljamo princip telemedicinskega spremljanja, kot se uporablja v telemedicinski storitvi, ki jo ponuja Center za zdravje na daljavo (CE- ZAR), ki deluje v okviru Splošne bolnišnice Slovenj Gradec. Center nudi storitve bolnikom s slad- korno boleznijo tipa 2 in/oz. bolnikom s kroničnim srčnim popuščanjem. Storitev smo vzpostavili v letu 2014 v okviru evropskega projekta UNITED4HEALTH – Združeni za zdravje. Od začetka dela je center nudil storitve že 550 bolnikom koroške in saleške regije. Nekateri od njih prejemajo storitev že dve leti. Klinični rezultati telemedicinskega spremljanja, objavljeni drugje, potrjujejo, da so avtorji uporabili ustrezen model storitve in da je izvedba tehnične rešitve primerna in sprejemljiva za vse uporabnike storitve: za bolnike in za vključene zdravstvene delavce. Zdrav Vestn | november – december 2016 | Letnik 85 telemedicine support to patients with chronic diseases for better long-term control at home 677 KLinični priMer Background Europe is facing a challenge of de- livering quality healthcare to all its ci- tizens at an affordable cost. Prolonged medical care for the ageing society, the costs of managing chronic diseases, and the increasing demand by citizens are major factors that contribute to the pro- blem of delivering quality healthcare (1). The emerging situation calls for a chan- ge in the way healthcare is delivered and the way medical knowledge is managed and transferred to clinical practice  (2). The European Commission sees the implementation of new services, ba- sed on new models implementing new information and telecommunication technologies (ICT), which have the po- tential of being more efficient than the current established models (1), as a way of solving these problems. They should empower the user in their home enviro- nment in the self-management of their disease. Services to support patients with long term conditions e.g. diabetes mellitus (DM) or chronic heart failure (CHF) in their living environment are inevitable for the European as well as Slovenian healthcare system in the fu- ture. Support to patients with DM and/or CHF in their home environment aims at empowering the user in his self-manage- ment of the disease thus preventing the deterioration of a person’s health con- dition, avoiding medical complications and minimising secondary consequen- ces of the illness. Those patients are li- kely to benefit from timely and adequa- te response by health care providers to deteriorated conditions detected by the telemedicine system upon the received data. DM patients should keep their blo- od glucose level within the determined interval. CHF patients should take care to maintain adequate blood pressure, heart rate and body weight values. The professional challenge for DM and CHF clinicians is to successfully conduct the- rapy in physically absent patients. In or- der to provide telemedicine service to patients at home, an adequate service infrastructure and the service provision model to support medical intervention at a distance need to be developed and established. Services are based either on TV, tele- conferencing, telemetry, SMS messaging, emails and other means of communi- cation. There are different telemedicine service infrastructures  (3,4) as well as organisational models in place  (5). Dif- ferences arise from local circumstances and the availability of resources, but they all have the same goal: all should result in a higher quality of life of the remotely monitored patients. An applied telemedicine (TM) ser- vice model has to prove its efficiency by positive clinical outcomes. In the li- terature there are several reports on the successful implementation of home tele- medicine based on telemonitoring when implementing an adequate response sy- stem to the detected changes in health status. Meta-analysis of Nakamura et al.  (6) confirms that telemonitoring co- uld be an effective add-on tool for ma- naging elderly patients with DM and/or CHF. Remote monitoring in CHF pati- ent management may have a significant protective clinical effect on patients in comparison with those receiving regular care (7). Similarly, studies of remote mo- nitoring in DM2 patients show positive effects e.g.an improvement (lowering) in HbA1c levels (8,9). 678 Zdrav Vestn | november – december 2016 | Letnik 85 JaVno ZdraVstVo (VarstVo pri deLu) Figure 1: telemedicine service model implemented at the CeZar telemedicine centre to support dM2 and CHF patients at home. see text for details. Telemonitoring service at the General Hospital Slovenj Gradec In this paper the principles of patient telemonitoring are presented as applied within a TM support service provided by the Regional Centre for Telehealth (CE- ZAR) located at the General Hospital Slovenj Gradec, Slovenia (GH-SG) (10). The service was set up in 2014 as part of a European project called UNITED- 4HEALTH–UNIversal Solutions in Telemedicine Deployment for Europe- an HEALTH care (11). In the period of 2013–2015 the GH-SG, the Healthcare Centre (HC-Ravne) and a supporting organisation, MKS Electronic Systems Ltd., Ljubljana (MKS Ltd.) participated in the UNITED4HEALTH project that is considered to be the largest Europe- an R&D telemedicine project in terms of the number of patients involved. The aim of the project is to spread a TM mo- del and evaluation criteria set up within another EU project called Renewing Health  (12), to countries that have not yet introduced TM services. Fifteen par- tners in ten EU member states piloted projects in their regions offering TM service for at least a year to almost 6,000 patients suffering from CHF, diabetes, chronic obstructive pulmonary disease or hypertension. At the start of the UNITED4HE- ALTH project, Slovenia did not have any type of operational home telemoni- toring service. For this reason, GH-SG, HC-Ravne and MKS Ltd. decided to set up its own TM service to support 400 patients with DM type 2 (DM2) and 200 patients with CHF to reach the project target set out for Slovenia. Since April 2014 the CEZAR regional centre for te- lehealth has been providing telemedical support to DM2 and CHF patients in the Carinthia region of Slovenia. In the arti- cle, the TM service is presented through its mode, infrastructure, service delivery pathway and a clinical portal built to su- pport the TM service. The patient recru- itment process, the clinical results of the telemedicine support to patients with chronic diseases for better long-term control at home 679 KLinični priMer telemonitoring and user satisfaction are not within the scope of this paper. Telemonitoring service model and infrastructure A basic technological solution for the TM service implemented at the GH- -SG is presented in Figure 1. It is built on the UNITED4HEALTH project service model (3). The Slovenian UNITED4HE- ALTH team upgraded it with an organi- sational infrastructure. A PATIENT (No. 1 in Figure 1), as a TM support service user, takes measu- rements of health related data at home using VITAL MONITORS. A DM2 pa- tient uses a glucometer to measure his blood glucose level and a CHF patient measures his blood pressure using a blo- od pressure meter with an incorporated heart rate meter, body weight using a scale, and oxygen saturation using a pul- se oximeter. Each measured value is sent from each of the devices through a Blu- etooth (No. 2) link to a GATEWAY that is a mobile smart phone. Data is forwar- ded to the regional TM centre through a mobile network (No. 3). There, the data is passed on to a broadband Local Area Network (LAN) and stored on the TM service SERVER. A REGIONAL CEN- TRE OPERATOR monitors the patient’s data (No. 5) when alerted, and responds (primary level interventions), e.g. by cal- ling the patient when the measured data is out of his/her personally specified ran- ge. A DM2 and/or CHF specialist (SPE- CIALISED DOCTOR) or other healt- hcare professional on duty is alerted by the OPERATOR (No. 4) when a second level intervention is required. FAMILY members are also informed by the regi- onal centre operator (No. 7) when their assistance is needed, e.g. to take their re- lative to see a DM or CHF SPECIALIST. All of the involved parties send their feedback to the REGIONAL CENTRE OPERATOR (No. 7) using standard me- ans of communication (phone, e-mail, SMS, written reports). A GP is not part of the response system, as the cardiolo- gists at SB-SG cover both secondary and primary healthcare needs. The PATIENT has an optional communication channel (5) to contact the REGIONAL CENTRE OPERATOR by phone. The same chan- nel (No. 6) is used by the REGIONAL CENTRE OPERATOR when the PATI- ENT is contacted. The TM-collected data are securely saved on the SERVER behind a firewall of the TM service provider (GH/SG). Authorised medical staff has an access to the data through a Virtual Private Net- work (VPN) channel (6). The technological solution and the equipment were provided by a German company Health Insight Solution (13) in cooperation with a Slovenian company MKS Ltd. (14). Telemedicine service description A patient using the TM service at home takes daily measurements of his/ her blood sugar (DM2 patients) or we- ight, blood pressure, heart rate and oxygenation (CHF patients) following the recommendation of his/her specia- list regarding the time and frequency of the measurements. The measuring devi- ces are provided by the TM service pro- vider. This also includes a mobile phone serving as the gateway. The gateway and the measurement devices are matched and personalised before being passed on to the patient. After the measurement is taken, within a minute the patient’s data is automatically sent from the measuring device to the gateway and then further to the server in GH-SG without any inter- vention by the patient. 680 Zdrav Vestn | november – december 2016 | Letnik 85 JaVno ZdraVstVo (VarstVo pri deLu) Figure 2: a screenshot from the clinical portal presenting daily collected data for one of the CHF patients. The TM service server compares the measured data to the pre-set personali- zed values for each data type. If the me- asured value exceeds the threshold limit set individually by the medical specialist, the TM centre coordinator (a nurse) re- ceives a warning email. The coordinator calls the patient by phone to get more in- formation on the background of the out- -of-range data values. The measurements are repeated if there is any doubt as to the reliability of the data. If the measure- ments confirm a deteriorated condition, or they are indicated by the patient him/ herself, the coordinator consults the spe- cialist on duty and informs him/her on the findings. The specialist decides on the action to be taken by the patient. This could be advice, a change in medication / treatment, a visit to his/her GP, a visit to the hospital clinic during regular wor- king hours, or an emergency visit to the hospital. The information is conveyed to the patient by the coordinator by phone, and later on as a written report by surfa- ce mail. Every phone call, advice, change in therapy, home visit or other action is registered as a comment in the patient’s record on the clinical portal. The respon- se system was organised during the mor- ning shift only. Presentation of TM collected data for DM2 and CHF patients A web-based portal was designed for clinicians by the Slovenian team enabling the medical staff to manage the patient’s data. In Figure 2 a screenshot from the clinical portal presents daily collected data for one of the CHF patients. Valu- es for heart rate (pulse), blood pressure, oxygen saturation (SPO) and body we- ight are shown in columns. The com- ments recorded at medical intervention or made when contacting the patient are in the right column (Comment/Report). The heart symbol in the numeric values for pulse indicates an arrhythmia detec- ted by the blood pressure meter. In Figure 3 a screenshot from the cli- nical portal presents weekly collected numerical data of blood sugar level va- lues measured over a four-month peri- telemedicine support to patients with chronic diseases for better long-term control at home 681 KLinični priMer Figure 3: a screenshot from the clinical portal presenting weekly collected numerical data for blood sugar of one of the dM patients over a four-month period. od by one of the DM patients. An apple symbol indicates the time of a blood sugar measurement in relation to food intake: a full apple symbol indicates that the measurement was done before a meal and the half-eaten one marks the post meal measurement. The comments recorded during a medical intervention or by contacting the patient are in the ri- ght column (Comment/Report). In Figure 4 the measured blood glu- cose level values are presented graphi- cally. The graph is a screenshot from the clinical portal presenting weekly collected data of the blood glucose level of one of the DM2 patients in the last 12 months. The data is separated according to morning, mid-day, evening and night measurements. The values are compared to a line at 10  mmol/L of blood gluco- se. The green triangle symbols above the top graph indicate medical interventions or contacts with the patient. Discussion Several approaches have been repor- ted in the literature that is available on setting-up a telemedicine service to su- pport patients at home  (9,15,16). They differ from one medical discipline to another by using different methods and tools. No common rules exist as to what a TM solution model should look like. Also in almost every European country research and development groups have been piloting TM services thus seeking their own sustainable telemedicine mo- del. TM services in the European mem- ber states are at different level of imple- mentation (17). Different TM approaches and models are also used within pilots and projects supporting the same group of patients. This is reflected in a docu- ment resulting from the UNITED4HE- ALTH project and published by the EU Commission “Telehealth in Practice– Care Delivery Models from 14 Regions in Europe” (3) where nine different TM service models were used to support DM patients in nine European regions and four to support CHF patients at home in four European regions. A TM service model should be a response to patients’ needs, taking into account the existing clinical practice and available resources. The Slovenian partners in the UNI- TED4HEALTH project started building 682 Zdrav Vestn | november – december 2016 | Letnik 85 JaVno ZdraVstVo (VarstVo pri deLu) Figure 4: a screenshot from the clinical portal graphically presenting weekly collected data of blood sugar measurements of one of the dM patients in the last 12 months. their TM service from a “green field”, so they were unrestricted in their approach as to how to realise the suggested UNI- TED4HEALTH service model for DM2 telemedicine support to patients with chronic diseases for better long-term control at home 683 KLinični priMer and CHF patients. They decided to im- plement a technical solution based on telemonitoring that is completely mobile and does not require any patient inter- vention when taking measurements. The implemented service model proved to be functional, effective, reliable and useful. Also, the equipment used by the pati- ent completely satisfied the functional requirements. There were several techni- cal and organisational measures taken in which the system performed reliably, e.g. measured data aggregated in the mobile phone if a mobile signal was not availa- ble. Data was transferred to the hospital when the network was once again avai- lable. Additionally, technical support was organised at three levels to support pati- ents and the staff at the regional TM cen- tre CEZAR. On the organisational level, steps were taken to minimise potential difficulties in using the TM service, e.g. potential TM users and their caregivers were trained prior to enrolment to ma- nage the devices and instructed on how to act in case of difficulties. Consequen- tly, using the new ICT based TM support service was not a burden to any person involved. The medical response system that was in place was effective and reassured the patients supported at home. They would get a phone call, advice to change their therapy or were visited at home. In ad- dition to the TM service, standard path- ways were also available to access medi- cal help in potentially critical situations. For the patients the most important fea- tures of the service were the easy use of the equipment (technical issue) and that they were contacted by the TM centre staff every time the data provided by the TM system indicated a potential dete- rioration of their disease-related health condition (organisational issue). The medical professionals involved in the TM support service (one TM centre operator, two DM and one CHF specia- lists) recognised the usefulness and the effectiveness of the TM service for them and for the supported patients. They were surprised at the simplicity of the use of the technological solution that provides objective data on the observed patient’s health indicators. For them the most va- luable part of the solution was the clini- cal portal with aggregated patient’s per- sonal, medical and TM data. The portal was custom designed to support their work with patients. It contains several other modules with tools for operati- onal work, e.g. for the management of a patient’s personal and health-related data, to report to patients, to document the TM data in the patient’s personal re- cords, to notify the patients’ GPs on their patient involvement in the TM service, and for sending SMS notices to the pati- ents. Other modules for the operational running of the TM centre were also esta- blished, e.g. an assets management mo- dule and data analysis and a presentation module, etc. Our service was set-up in 2014 as part of a European project called UNITED- 4HEALTH. Since then, over 550 patients from the Carinthia and Saleška regions (Slovenia) have received telemedicine support. The results of the implementati- on of the presented TM service are outsi- de the scope of this paper and have been published elsewhere (8,18-23). However, according to the published literature, the selected TM service model is adequate and the implemented technological so- lution is useful and acceptable for both the patients and clinicians. Conclusions The implemented service model has proven to be functional, effective, and reliable when providing TM support to DM2 and CHF patients. 684 Zdrav Vestn | november – december 2016 | Letnik 85 JaVno ZdraVstVo (VarstVo pri deLu) The TM system provided objective data on the observed patient’s health indicators (blood glucose level, blood pressure, heart rate, body weight, oxygen saturation) and the completely mobile technical solution of the service at the patient’s side was adequate and easy for the patients to use. There was an efficient support service in place to help them re- solve potential difficulties with regard to the use of the equipment. The medical professionals involved in the TM service recognised its value for their clinical work and for the supported patients. In addition, cooperation with the patients strengthened and patients were empowered at self-care in their home environment. Acknowledgements The authors acknowledge a major contribution from other co-workers in the UNITED4HEALTH project in parti- cular, and express their gratitude to Mrs. Majda Kladnik, Ms. Maja Rakuša of GH Slovenj Gradec and Mr. Dare Oberžan of MKS Ltd., Ljubljana. Details of ethics approval The National Medical Ethics Com- mittee of the General Hospital of Slo- venj Gradec approved the study on 18 October 2013. An informed consent was obtained from each patient before being enrolled in the project. Funding The work was co-financed by the European Commission under the UNI- TED4HEALTH project (CIP ICT PSP GA No 325215), the General Hospital of Slovenj Gradec and The Primary Health Care Centre Ravne na Koroškem. References 1. 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