Design of a Remote Treatment Monitoring and Seizure Warning

System Framework for Epilepsy Patients

C. L. Martínez-González

, J. Mendizabal Navarro

and N. I. Plascencia Álvarez

Programa de Posgrado en Ingeniería de Sistemas, Instituto Politécnico Nacional, Zacatenco, Av. IPN S/N,

Del. Gustavo A. Madero, México, D.F., México

Escuela Superior de Cómputo, Av. Juan de Dios Bátiz esq. Av. Miguel Othón de Mendizábal, Col. Lindavista.

Del. Gustavo A. Madero. México, D.F., México

Centro Médico Nacional 20 de Noviembre, Av. Felix Cuevas 540, Col. Del Valle,

Del. Benito Juarez, México D.F., México

Keywords: Remote Treatment Monitoring System, Epilepsy, Mobile Technology, Seizure Warning, Patient Location.

Abstract: Personal health care technologies in chronic diseases face the challenge to design holistic approaches where

health care involves not only the medical specialist for treatment and monitoring, but the patient and the

family. Epilepsy is a term used for a group of chronic disorders with diverse etiology characterized by

recurrent seizures, caused by an abnormal electrical activity in the brain. Treatment monitoring requires

continuous collaboration of the patient and the family to register manually a diary of activities, seizures,

seizures triggers and symptoms associated to medication in order to reach optimal therapy. Patients with

non-controlled seizures and their families have to deal with a restricted quality of life: the patient is exposed

to physical risks when seizures appear under any circumstance and place. In this paper a remote patient

treatment monitoring and warning system framework design based on mobile technology is proposed, with

multiple input, seizure detection with a smartphone accelerometer, automatic and manual seizure warning

and location of the patient through GPS and a social support network. This design approach is patient-and

family-centred, as they are the source of individual information in a particular environment, condition and

treatment response. It also represents a first proposal of a potential ubiquitous health care system through a

wearable device.

1 INTRODUCTION

A challenge in health care technology involves the

non-integrated approach of specialists records of

patients information, the large volume of data and

the difficulties with appropriate information retrieval

that have resulted in a lack of use of available

electronic health records (EHR) and personalized

health records (PHR) while adherence of patients to

these systems need to take to account motivation and

self-care (Wang & Huang, 2012). In the near future,

ubiquitous technology for health care will be a

common environment in everyday life with

monitoring and prevention purposes (Omary et al.,

2011), however, actual technology provides useful

and powerful frameworks to design integrative

systems where data volume and information

actualization should not be an important issue.

Patient-centred integrative systems based on

individual modules from different sources

(ubiquitous or not) with independent updating, still

have to be designed. When health has become the

following target in personal technology, even more

with Apple HealthKit potential, health and well-

being smartphone applications represent the 40% of

current development (Furht and Agarwal, 2013) with

a growing trend.

Several mobile applications are available to aid

different chronic diseases like diabetes, obesity,

heart diseases, bipolar disorder and epilepsy, for

instance. In epilepsy, functionalities like seizure and

symptoms diary; medical and emergency

information; record of medications; seizure tracking,

videotaping and even detection have been widely

used for treatment monitoring and diagnosis support

(Epilepsy Foundation; National Society for

Epilepsy; The National Centre for Young People

with Epilepsy, among others). These applications are

546

Martínez-González C., Mendizabal Navarro J. and Plascencia Álvarez N..

Design of a Remote Treatment Monitoring and Seizure Warning System Framework for Epilepsy Patients.

DOI: 10.5220/0005274405460552

In Proceedings of the International Conference on Health Informatics (HEALTHINF-2015), pages 546-552

ISBN: 978-989-758-068-0

 2015 SCITEPRESS (Science and Technology Publications, Lda.)

not linked to an integrated system, do not solve the

main problems of the medical specialist, do not

update the patient’s record, cannot be used for

emergency situations and more important, not all of

them involve family intervention, therefore losing

important information and feedback.

In many chronic diseases, a holistic approach for

treatment is mandatory. The patient cannot be the

only source of data for monitoring, for inherent

reasons of the disease or insufficient information

acquired by this mean. A common way to face this

challenge is a combination of interventions as

mechanisms to enhance adherence of the patient’s

behavior on taking medication, modifying habits and

attending clinics, according to medical advice and

including family participation (McDonald et al.,

2002) or using a patient-centered approach. Yet this

kind of combined interventions do not make use of

an integrative technology support system.

Consequently, treatment monitoring of chronic

diseases requires models that consider the

participation of all the roles involved in the disease:

the patient as the focus, the medical specialist and

the family, e.g. in a real patient-and family-centered

approach.

The system framework that we propose for

epilepsy is intended to accomplish the three main

issues in m-health (Furht & Agarwal, 2013) i) access

from anywhere and anytime, ii) quality since is

designed as an integrated system and iii) value for

the target to provide health care in a efficient and

effective way. It is divided in three parts.

The first part is a mobile medical device

designed for the patient with a small personal health

system, with an informative module, medication

alerts, social network, automatic seizure detection

and manual or automatic seizure warning –that takes

advantage of the smartphone accelerometer– and

physical location of the patient with GPS data. The

second part is mobile medical app for the caregiver

use, which contains symptoms observation diary,

seizure warning, seizure recording, social network

and first aid emergency programmed calls. The third

part is the monitoring system by a web system for

the medical specialist use; it involves the patient

record (personal data, treatment and seizure

monitoring, seizure records, EEG data), seizure

warnings and emergency services contact. All of

these modules linked by a cloud-computing service.

Current mobile apps or systems are designed

only for the one final user, as independent medical

information systems, without integration of the

information from all the input sources; this is the

principal innovative scheme of the present work. It

takes into account all the stakeholders that must be

involved, is user-centered (UCD) in each module,

but patient-and family-centered as an integrative

system: the context must be defined on the particular

environment and condition of each patient, thus, the

profile and use is personalized, the benefit is

pretended for the patient, the family and the

specialist. Furthermore, an important consequence is

the potential use for data generated by the system,

for statistical research in epilepsy patients’ habits

and seizure occurrence. This model also represents a

first proposal to be part of a potential ubiquitous

health care system.

2 HEALTH CARE

REQUIREMENTS IN EPILEPSY

Epilepsy is a term used for a group of disorders with

diverse etiology (infections, birth problems, tumors,

trauma and in many cases, origin is unknown),

characterized by recurrent seizures, caused by an

abnormal electrical activity in the brain. In the

world, around 50 million people have epilepsy

(World Health Organization 2012). Any person,

without previous symptoms or circumstances, is

susceptible to epilepsy. Diagnosis is achieved in a

precise way by seizures description and different

medical studies as electromagnetic resonance,

tomography and particularly electroencephalograms.

The specialists for this diagnosis are a neurologist

and an epileptologist. The most known and shocking

kind of seizure is a generalized tonic-clonic, where

the patient loses consciousness and the entire body

convulsions.

Available treatment of a diagnosed patient

depends upon the classification of the epilepsy and

the seizures; it consists on stopping seizures by

medication with anti-epileptic drugs (AEDs),

securing appropriate habits, specific diet and in

determined cases, surgery is indicated, besides

alternative treatments. Treatment monitoring

requires continuous collaboration of the patient and

his family to register a diary of activities, seizures,

seizures triggers and associated symptoms to update

the specialist and analyse medication efficacy and

tolerability to reach the optimal therapy with the

exact combination of AEDs in certain doses.

In some patients, seizures are announced by a

certain perception called “aura”, a sensory signal

like visual, auditory, gustatory, olfactory

hallucination or the awareness that something is

wrong that indicates an imminent seizure. Then the

patient is able to warn someone or to avoid risks by

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547

himself. The patients that do not perceive this aura

and are in a vulnerable physical location suffer the

risk of accidents, falls and injuries.

Speaking about quality of life, the first of its

possible indicators, defined by Cribb (1985) is the

quality of lifestyle, associated to the patient’s

capacities and restrictions in their work, social and

home life; the second possible indicator is mental

health, where emotional well-being in all levels

takes into account. Therefore, patients with non-

controlled epileptic seizures and their families have

to deal with a restricted quality of life due to the

inherent risks of the disease: the patient is exposed

to physical risks when seizures appear under any

circumstance at any place. Also, per se, epilepsy is

involved in underlying discrimination and stigma

(Forsgren et al., 2013) and still risks prevention in

uncontrolled seizures is limited to the self-exile,

affecting family, relatives or caregivers.

Records of seizures observation and medication

achieve actual treatment monitoring.

Accordingly, current technology can be

extraordinary to support some of the intrinsic

mechanisms of the disease with an appropriate

holistic design approach, a patient-and-family

centred design.

3 PATIENT-AND-FAMILY

CENTRED DESIGN

As a starting point for the design approach of this

system framework, the patient-centred design basis

was proposed —defined by Baecker as the design

with users or patients in a participatory design—

implicating the sense of person-centred care, as

McCormack et al. (2011) established: an approach

that involves care providers, patients, and others

significant to them; thenceforth converting our

overall design approach in a patient-and-family

centred design.

The Institute of Patient-and-Family-Centered

Care defines the core concepts in patient-and-family

centred care as 1) the dignity and respect of patient

and family perspectives and choices, 2) the

information sharing, 3) the participation and 4) the

collaboration of them in care and decision-making.

In ambulatory care specifically, the patient and the

family are conveyed to be integral part of the health

care team, while self-management of the chronic

condition is desirable, getting all them involved in

the planning, implementation and evaluation of

chronic care strategies (Johnson et al. 2008).

3.1 Design Considerations for Epilepsy

Usability and accessibility are the main features in

user-centred design, directly related with a integral

approach.

In this remote treatment monitoring and warning

system framework for epilepsy, a particular profile

of patient must be stated. The specific users of the

patient app are persons already diagnosed with

epilepsy to achieve treatment monitoring by

observing medication effects on seizures recurrence,

principally patients with uncontrolled seizures that

need to be supervised by a caregiver, commonly

someone in the family. Seizure detection

functionality is defined for tonic-clonic seizures;

thenceforth other kind of seizures may not be

detected.

A patient with uncontrolled epilepsy seizures

suffers of anxiety due to the unpredictability of the

seizures, he or she does not have normal activities

and the daily routine needs to contemplate the

possibility of falls or injuries.

It is comprehensible that the patient and the

family must be considered as the principal role for

the design, since the prevalence of use of the system

depends on the participation of both users.

The central topics concerning the whole system

are:

 Personal Health Record. Patient is able to

upload personal information related to general

data, emergency contact data and health data:

medical history, allergies, actual diagnosis and

medication. The specialist can upload strategic

results of primary neurologic diagnostic

technics like magnetic resonance and

tomography and principal laboratory tests

results like blood test and urine test, if they are

able.

 Treatment monitoring. Appropriate medication

adherence is required in a patient that suffers

epilepsy; monitoring effects and tolerability is

overriding (Campos and Kanner, 2004),

especially with a new anti-epileptic drug, a new

combination of them or a different dose. Side

effects of medication are important to watch.

This monitoring is proposed for the specialist

use.

 Habits, mood and daily activities. Missing

medication, emotional stress, sleep deprivation,

fatigue, missing meals, fever and smoking are

the most common —but not all— triggering

factors of seizures. Identification and

recognition of individual seizure triggers and

may be beneficial for the treatment; registering

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daily habits, mood and specific activities will

help to identify the most common for each

patient (Balamurugana et al. 2013). Selection

of symptoms, moods and daily activities will

be available.

 Seizure records. A daily registration of seizures

in a detailed form is useful to determine the

medication efficacy. Time, duration and

detailed description are information needed for

a correct monitoring. A video recording of the

seizure is very valuable, since a patient does

not always exhibit seizures during a medical

examination.

 Seizure detection, seizure warnings and patient

location. Paroxysm will be detected by the

accelerometer of the smartphone running the

patient’s app, when seizure is detected, a

message will appear to confirm a false

detection. If this is discarded, an automatic

warning will be sent to the caregiver with the

physic location of the patient. If the patient has

an “aura”, he or she will be able to send a

manual warning of an imminent seizure. In

both cases, an urgency ID screen will be

displayed in the smartphone.

 Support social network. A collaborative

network is a valuable element in this

framework. Epilepsy patients and families live

in a constant worry, anxiety and fear. This

network could be a platform to share

experiences and give emotional support.

3.1.1 Usability and Accessibility

In user-centred design (UCD), a specific iterative

cycle is outlined in ISO 9241-210 (Goldberg et al.,

2011), where the context of the system use is the

starting point –in this framework, for each module,

the patient, the caregiver or relative and the

specialist–, the requirements specification is the

following consideration, to produce, afterwards, the

design solutions and evaluate them to update the

design until usability is achieved. For the three user

profiles of this system, the cycle of UCD needs to be

completed.

Usability is considered from the design to the

final use of the system; each module must be

designed to be effective, efficient and satisfactory in

the specified context of use for each user profile

(ISO/IEC, 1998). Usability also has to take into

account training for the patient, the caregiver or

relative and the specialist of the whole system

framework in order to understand the main objective

and the particular goals for each profile.

Epilepsy is a chronic disease that may or not disable

the patient; in either way accessibility will delimit

the use of the mobile device by the patient. If the

patient is not able to operate the mobile device or

use the mobile app, he or she may not use all the

potential of the system, but the treatment monitoring

with the module of the caregiver can be a supporting

data source.

Like any other healthcare system, in epilepsy,

confidentiality of the information is a significant

subject, correspondingly to the trust of the patient on

the security of the data. Confidentiality must be

guaranteed as a primary expectation of the users,

principally, of the patient. Signed consent must be

considered for each patient and the caregiver

(family), focusing on confidentiality and use of the

data.

4 SYSTEM FRAMEWORK

M-Health or mobile health is the evolution of e-

health, with the use of mobile devices and wireless

network technologies for healthcare services

(Istepanian et al., 2006). The most common mobile

health systems are mobile health monitoring

systems, designed to store monitor patient status and

have been proposed for different purposes,

In the international standardization ISO/TC 215,

the proposed module for the caregiver is classified in

the category of Mobile Medical App, with the

intended use to support the treatment and monitoring

of the disease. The particular utilization of the

accelerometer as a sensor to detect seizures, gives

this patients module a function as a mobile medical

device (Kim & Song, 2013) with a Personal Health

Record (PHR).

Figure 1: System framework architecture.

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549

The patient and the family modules of the system

can be also considered home use devices, since their

use is proposed for an environment outside a

professional healthcare facility (FDA, 2014).

Figure 1 shows the system framework

architecture, defined by three layers and two levels,

the first level is the backend and the second level,

the controller and interface.

4.1 Architecture

The first layer is data layer or backend, the second is

business layer or controller and the third is

presentation layer or interface. The level one is the

backend and the second level is formed by the other

two layers, business layer and interface.

In backend, patients and specialist data will be in

stored in a cloud database, allowing to be retrieved

from any business layer to be shown by the

interface.

For the controller, the patient and caregiver apps

were proposed to be developed for iOS and the

specialist module for web browser visualization.

Required data are obtained by requests to the data

layer.

Mobile apps need an intuitive interface,

according to the visual design of components from

Apple guides. Data obtained by the requests must be

correctly showed in this layer.

4.1.1 Specifications

For backend, web services were proposed on Ruby

programming language and the database system

manager, PosgreSQL. Cloud storage achieved by

Parse backend platform for iOS.

For the controller or business layer, the

programming language is SWIFT for iOS platform

for mobile apps and Ruby on Rails for web access.

As for the interface, for mobile apps, the native

of iOS was proposed and for web access interface,

JavaScript, CSS and HTML5.

4.1.2 Notifications, Warnings and Seizure

Detection

Push notifications are used to send seizures warnings

to the app for the relative or caregiver. The patient or

the caregiver must program drug administration

schedules in the specific app for each profile user.

To detect seizures, the accelerometer of the iOS

device (iPhone) is used. Continuous shaking is

considered as the paroxysm of a seizure, then a

warning message will appear on the screen to

discard a false alarm and in a positive case, seizure

detection warning will be send to the caregiver app.

GPS data will be attached to indicate the current

location of the patient.

Patient’s app will show an urgency ID screen

with emergency contact data and aid information

when a seizure is detected or manually warned

(Figure 2).

Figure 2: Seizure detection and alert with patient location.

4.2 Accuracy and Specificity

In-situ and in-depth trials must be planned and

achieved as a main part of the methodology of

development to determine reliability of the system.

The defined user’s profile of the patient and the

or caregiver or family modules is an epilepsy patient

with tonic-clonic seizures and a caregiver that is in

charge of the health care and support, the patient

could be a child, an adolescent or adult, as long as

the caregiver is engaged with the treatment

monitoring and updating of the data. A typical use of

the system depends on the participation of the

patient, the caregiver and the specialist.

4.3 Development Methodology

Rational Unified Process is a conventionally used

software engineering methodology. Roles, activities

and artefacts delineate it and use cases and iterative

processes are the main features. In the present work,

RUP was proposed implementing UCD through an

explicit role of usability designer, as Svanæs &

Gulliksen (2008) recommended. There have been

some experiences with this methodology for systems

development in industry without desirable success

(Vukelja et al., 2010) in the case of healthcare

information systems, the participation of particular

stakeholders in usability design is crucial and final

users must share this role in the development team.

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5 CONCLUSIONS

The system framework design presented here is a

hybrid approach to a remote treatment monitoring

with a module of a cloud Personal Health Record for

the patient and the family (both functioning as home

use medical devices) and a module of an Electronic

Health Record for the specialist, based on an

integrative holistic approach of patient-and-family

centred, that could be linked to other medical

systems.

The main use requirement for the patient and the

family is active participation; for the patient to carry

the mobile device, especially in environments out of

home, to fulfil information of habits and perceptions

and for the family or caregiver and to fulfil

observation data of the patient’ habits and seizures.

Information collected in this way gives the

patient the possibility to share his or her health

history when an emergency occurs.

This framework is intended to be an holistic

approach design, considering all roles involved in a

remote treatment monitoring, the design

methodology could be used to design for other

chronic diseases.

Patient’s module could serve as a basic approach

to a pervasive system as well, reminding the patient

to keep an appropriate lifestyle and determining real

criteria for detecting personal seizure triggers (lack

of sleep, certain food or activities, personal

conditions or sensibility and stress), when a large

amount data is collected and analysed to determine

personal tendencies that even offers an interesting

potential use of collected data for research purposes,

taking into account confidentiality and security of

the information.

After current development, the accelerometer of

the smartphone for seizure detection will be

substituted by a very sensitive sensor kit in a

wearable device to detect other kind of seizures with

minimum clinic symptoms like tremors and

temperature and cardiac rhythm changes.

ACKNOWLEDGEMENTS

Authors acknowledge the Instituto Politécnico

Nacional, CONACYT, COFAA and EDI for

financial support of this work.

REFERENCES

Baecker, J., A taxonomy of technology for cognition -

product and process, Available at: http://ron.taglab.

ca/papers/D60.pdf.

Balamurugana, E. et al., 2013. Perceived trigger factors of

seizures in persons with epilepsy. Seizure, vol. 22, no.

9, pp.743–747.

Campos, M.G. & Kanner, A.M. eds., 2004. Epilepsias.

Diagnóstico y tratamiento, Santiago de Chile:

Mediterráneo.

Cribb, A., 1985. Quality of life- a response to K. C.

Calman. Journal of Medical Ethics, vol. 11, pp.142–

145.

Epilepsy Foundation, My Epilepsy Diary.

FDA Federal Drug Administration, 2014. Design

Considerations for Devices Intended for Home Use.

Guidance for Industry and Food and Drug

Administration Staff, Available at: http://www.

fda.gov/downloads/MedicalDevices/DeviceRegulation

andGuidance/GuidanceDocuments/UCM331681.pdf.

Forsgren, L. et al., 2013. On the experience of stigma by

persons with epilepsy in Sweden and Iran—A

comparative study. Seizure, vol. 22, pp.748–751.

Furht, B. & Agarwal, A. eds., 2013. Handbook of Medical

and Healthcare Technologies, Springer New York.

Goldberg, L. et al., 2011. Usability and accessibility in

consumer health informatics current trends and future

challenges. American journal of preventive medicine,

vol. 40, no. 5 Suppl 2, pp.S187–97. Available at:

http://www.ncbi.nlm.nih.gov/pubmed/21521594

[Accessed July 11, 2014].

ISO/IEC, 1998. ISO/IEC. International standard 9241-

151: ergonomic requirements for offıce work with

visual display terminals (VDTs), Part 11: Guidance on

usability.,

Istepanian, R., Laxminarayan, S. & Pattichis, C.S., 2006.

Ubiquitous M-Health Systems and the Convergence

Towards 4G Mobile Technologies. In E. Mechelli-

Tzanakow, ed. M-Health: Emerging Mobile Health

Systems (Topics in Biomedical Engineering.

International Book Series). Springer, pp. 3–14.

Johnson, B. et al., 2008. Partnering with Patients and

Families to design a Patient- and Family-Centered

health Care system, Available at: http://www.

ipfcc.org/pdf/PartneringwithPatientsandFamilies.pdf.

Kim, I.K. & Song, J.H., 2013. Mobile Health reference

architectures. In International Conference on

Information Society (i-Society). IEEE, pp. 158–164.

Available at: http://ieeexplore.ieee.org/articleDetails.

jsp?arnumber=6636363 [Accessed September 9,

2014].

McCormack, B., Dewing, J. & McCance, T., 2011.

Developing Person-Centred Care: Addressing

Contextual Challenges Through Practice

Development. OJIN: The Online Journal of Issues in

Nursing, vol. 16, no. 2. Available at: http://nursing

world.org/MainMenuCategories/ANAMarketplace/A

NAPeriodicals/OJIN/TableofContents/Vol-16-

2011/No2-May-2011/Developing-Person-Centred-

Care.html?css=print.

McDonald, H.P., Garg, A.X. & Haynes, R.B., 2002.

Interventions to Enhance Patient Adherence to

DesignofaRemoteTreatmentMonitoringandSeizureWarningSystemFrameworkforEpilepsyPatients

551

Medication Prescriptions. JAMA, vol. 288, no. 22,

p.2868. Available at: http://jama.jamanetwork.com/

article.aspx?articleid=195605 [Accessed May 26,

2014].

National Society for Epilepsy, Epilepsy Society. Available

at: http://www.epilepsysociety.org.uk/free-epilepsy-

smartphone-app#.U7d8bxbvFqo [Accessed April 1,

2014].

Omary, Z. et al., 2011. Ubiquitous Healthcare Information

System: Assessment of its Impacts to Patient’s

Information. International Journal for Information

Security Research (IJISR), vol. 1, no. 1/2, pp.71–77.

Svanæs, D. & Gulliksen, J., 2008. Understanding the

context of design: towards tactical user centered

design. In NordiCHI. Lund, Sweden.

The National Centre for Young People with Epilepsy,

Young Epilepsy. Available at: http://youngepilepsy.

org.uk/all-about-epilepsy/epilepsy-app [Accessed June

10, 2014].

Vukelja, L., Opwis, K. & Müller, L., 2010. A Case Study

of User-Centred Design in Four Swiss RUP Projects.

Advances in Human-Computer Interaction, vol. 2010.

Wang, C.J. & Huang, A.T., 2012. Integrating Technology

Into Health Care. What will it take? American Medical

Association, vol. 307, no. 6, pp.569–570.

World Health Organization, 2012. Epilepsy. Fact Sheet N

999. Available at: http://www.who.int/mediacentre/

factsheets/fs999/en/ [Accessed September 1, 2014].

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