Community Research and Development Information Service - CORDIS

H2020

PD_manager Report Summary

Project ID: 643706
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - PD_manager (mhealth platform for Parkinson’s disease management)

Reporting period: 2015-01-01 to 2016-06-30

Summary of the context and overall objectives of the project

Parkinson’s disease (PD) is a complex chronic disease, individual disorder that most people live with for many years/decades. More than one million people live with PD in Europe today and this number is forecast to double by 2030. Also, there are predictions that by 2020 the number of diagnosed patients will be more than 12 million worldwide. It is the second most common neurodegenerative disease (after Alzheimer) and its prevalence will continue to grow as the population ages. Due to the disease complexity a multidisciplinary management involving several professions working together (neurologists, physiotherapists, speech and language therapists, occupational therapists, dieticians), is important to ensure that the patient retains his/her independence and continues to have the best quality of life possible. In the same context the role of the caregiver is of paramount importance.

The main objective of the PD_manager project is to build and evaluate an innovative mHealth ecosystem for PD management. PD_manager is a research project funded by the European Commission under the Horizon 2020 programme. Specifically, PD_manager was submitted in the PHC-26 topic Self-management of health and disease: citizen engagement and mHealth aimed at “Empowering citizens to manage their own health and disease will result in more cost-effective healthcare systems by improving utilisation of healthcare, enabling the management of chronic diseases outside institutions, improving health outcomes, and by encouraging healthy citizens to remain so.”

The PD_manager project aims to (see Figure 1):
• Use a set of mobile and wearable devices that will be used for symptoms monitoring and collection of adherence data.
• Assess motor and non-motor symptoms in Parkinson’s patients.
• Evaluate patients’ adherence to medical prescriptions.
• Conduct a dedicated nutritional study and empower game-based physiotherapy at home.
• Provide personalized suggestions for an optimal PD management plan.
• Propose an open architecture to support any commercial set of sensors within the Internet of Things concept.
• Model the behaviour of patients, caregivers, neurologists and other health-care providers.
• Educate patients, caregivers and healthcare providers with focus on occupational and speech therapies.

Different devices and wearable sensors will be used within PD_manager to carry out the continuous monitoring as well as to enable the performance of phone-based test and the delivery of education and training (see Figure 1):
• The wristband to continuously capture heart rate patterns, motion (with a 3-axis accelerometer) and skin temperature.
• The sensor insole, which is a novel product of Moticon (www.moticon.de), is an every-day, flexible and thin solution to measure distribution of pressure, acceleration, weight-bearing, balance and motion sequences.
• A smart pillbox, which will be used to track the medication adherence of the patient.
• A smartphone, which will be used to capture the other elements of the mHealth platform as well as to deliver some specific tests, training and educational material. Caregivers and clinicians are also provided with smartphone solutions to participate in the care process.

The work within the project is organized into seven main work packages (WPs). WP1 (Management) deals with project management concentrated in handling the progress of actual work made within the project, its quality control as well as financial and communication issues. WP2 (Publicity and Business Potential) focuses on establishing communication channels, dissemination and publication of the project results, defining and updating the Data Management Plan and the Exploitation Plan as well as handling and resolving Intellectual Property Rights (IPR) issues. WP3 (Needs and Tasks Analysis & Decision Making Models) aims at developing decision making models based on observations of users’ decision making in situ, the computational analysis of user decision making, and integrating it with the policy and ethical considerations, in order to inform the definition and development of an Open Architecture and enable/validate technology. The goals of WP4 (PD_manager R&D) are patients’ enrolment for data acquisition, analysis of these data for motor symptom monitoring, non-motor symptoms monitoring, which includes cognition, speech disturbances, etc., implementation of the PD nutrition study, gamification of physiotherapy, development of the Educational module and implementation of the Knowledge platform. WP5 (Analysis, modelling and integration for decision support) deals with mining of the patients’ data in order to extract new knowledge about their condition and get better insight into the disease, building of a decision support module to make suggestions to the clinicians for the modification in the disease management plan, developing of the PD_manager application on top of the knowledge management platform and mobile apps for Patients, Caregivers and Clinicians for the interaction with the PD_manager application and refining the system. Within WP6 (Re-evaluation of process based on user experience) we will organise and implement a large Pilot activity including 200 patients, evaluate the PD_manager intervention and evaluate the resource implications and costs of using PD_manager from the perspective of the health service provider. The goal of WP7 (Ethics requirements) is to guarantee that all studies involving human engagement will be done in accordance with European and national legislations. It addresses the procedures for identifying and recruiting participants, incidental findings policy, consent forms, procedures for data collection, storage, protection, maintenance, copies of ethical approvals and informed consent procedures.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In the first half of the project – as described below – we have made much progress towards implementing the above specified goals, and towards the formalisation of our approaches. We have also disseminated our work widely, through academic talks and publications, and also through public-facing activities and working with journalists. As an overview summary, our efforts in the first half of the project have led to:
• 8 papers and conference abstracts being published describing our technical contributions and presented in various venues (for further details see subsection 2.4 Task 2.1).
• A project web site containing all the relevant information about the project, including papers and other dissemination materials (http://www.parkinson-manager.eu/).
• Twitter account was opened at the beginning of the project (https://twitter.com/pd_manager_proj) and is constantly active.
• Mentions of the project in various public-facing outlets, and at various keynote talks.

The project is progressing fluently, with smooth collaboration among partners, and we are able to implement and experiment with more sophisticated app development. The rest of this section describes in more detail the main results achieved.
Prototype apps for covering several aspects for data collection and management of PD have been implemented and evaluated. Those prototypes and the other achievements are described below, with further details given in the reports for the individual work packages.
• In WP3 needs and requirements from different users (prescribing clinicians, support clinicians, patients, caregivers, etc.) were elicited. Moreover, the models of clinicians’ diagnostic behaviour were obtained, which explain the clinicians’ decisions well, indicating that the information captured by PD_manager can effectively support their decision making. Furthermore, the state of the art of the currently used technologies in PD management were explored and based on this document the equipment for the experiments was ordered. An open architecture was designed to support the implementation of PD_manager system considering technological and user centric requirements. The architectural approach was also defined and was revised when GLOBO exited the consortium due to bankruptcy. Both the mobile and the cloud part are well defined and they are being implemented to provide the necessary infrastructure for the pilot study in 2017.
• In WP4 we have performed the first clinical study with PD patients. Based on this data, a detailed motor and non-motor symptoms analysis has been performed. Cognitive and speech mobile apps were developed. Moreover, based on a nutrition study, a mobile app was developed to track the nutrition habits and medication therapy of the patients. Also we have developed a gamification package for physiotherapy including the “Fruit Picking” game (for improvement of patient’s reach) and the “10 cubes” game (for improvement of fine motoric). The Educational gallery has been developed with 11 recorded videos that reflect some of the most common situations/symptoms of the patient suffering from PD. The development of the PD_manager Knowledge Management Platform is an undergoing task based on the principles of open architecture approaches and the Internet of Things concept, built in a combination and orchestration of cloud and mobile architectures, “blue-print” enterprise frameworks and open source solutions.
• In WP5 the data mining and decision support work are ongoing tasks. Several promising results were obtained: Initial models, built by using decision trees and neural networks for detecting ON/OFF stage of PD, have shown satisfying accuracy (90% for detecting ON, 60% for detecting OFF). Also, for the decision support task, a data analysis stage gave a number of models developed from the D3.5 dataset, where it turned out that DEX models were already better than the ones obtained with decision trees.
• In addition to the above, the overall architecture of the PD_manager system, a deliverable which was not included in the DoW, has been developed.
• WP7 documented all the ethical procedures and documents that were used in the studies with human participants.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

PD_manager goes beyond the state of the art, since:

• We are using light and unobtrusive sensors for data capturing, especially the pressure sensors of the sensor insole haven’t been use in that context in the past.
• We are progressing well towards developing more accurate, specific and sensitive data analysis and decision support models based on past experience and background knowledge with the aim 1) to decide when medication change is needed (mainly based on the assessment of fluctuations and in the overall worsening of the patients) and 2) to automatically suggest an optimal medication plan that clinicians will approve.
• We are progressing in all parts of PD_manager’s holistic mhealth approach by combining several aspects for PD management: motor and non-motor symptoms detection, monitoring and evaluation, nutrition and gamification apps, educational gallery, decision support to manage the change of treatment, etc.

We have been particularly productive in terms of scientific dissemination of our work, with numerous papers published in top conferences and workshops. The feedback from the reviewers and the conference delegates has been very supportive, and we believe that our PD_manager system will become widely acceptable in the PD community. Moreover, our dissemination and Twitter activity has led to some interest from journalists at several national and international newspapers, who have reported on the PD_manager project. Taken together, all this gives us the confidence that the impact of the project will be substantial, and the usage of the apps will be widespread.

The potential impacts of the PD_manager project are listed below.

The informal caregiver (relatives, spouses, non-specialized nurses):
• Gets (daily or weekly) reports from the PD_manager nutrition app and the physiotherapy game in order to acknowledge the effort of the patient or to motivate-empower him/her to be more compliant. The caregiver also supports the patient to use the nutrition app and the game.
• Is sent a notification from the pillbox or the medication app for any missed pill in order to remind the patient take his medications.
• Is sent notifications when the patient needs to perform specific tests for cognition, speech, QoL, etc. and supports the patients do these tests.
• Is notified when the medication should be modified as indicated by the prescribing neurologist/ GP/ nurse through the PD_manager caregiver mobile app.
• Optionally, i.e. if the patient is instructed by the prescribing neurologist/ GP/ nurse, to wear all day long and carry with him a paired smartphone, the caregiver receives specific guidelines to support the patient. The caregiver activates activity and sleep monitoring modes in the band. The symptoms analysis is not exposed to the caregivers.
• Optionally, i.e. if the patient is instructed by the prescribing neurologist/ GP/ nurse, to wear insoles for gait assessment the caregiver again receives specific guidelines to support the patient. The gait analysis is not exposed to the caregiver.
• Is able to have sessions with psychologists/ psychiatrists through a secure video-therapy platform.
• Is educated about how to support the patient to cope with daily tasks and activities (occupational therapy) and manage speech, language and communication problems as well as eating, swallowing and drooling problems (speech and language therapy) and is more prepared for changes in the patient and increased symptomatology in order to stay in control of the disease management.

The patient:
• Uses daily the PD_manager nutrition app that includes nutrition and medication intake. He is also motivated to adhere to the nutrition plan.
• Does physiotherapy whenever instructed by the physiotherapist using the PD_manager game; the game on its own empowers the patient.
• Has the pillbox that provides data for the medication.
• Is sent notifications when he/ she needs to perform specific tests for cognition, speech, QoL, etc.
• Modifies the medication as indicated by the prescribing neurologist/ GP/ nurse through the PD_manager patient mobile app.
• Is sent notifications in case of poor nutrition, medication and physiotherapy adherence and he/she is encouraged to be more compliant.
• Is sent notifications in case he/she is compliant, like awards, e.g., this week you followed the management plan 100%, your symptoms seem to be better controlled over the last two weeks etc.
• Optionally, i.e. if instructed by the prescribing neurologist/ GP/ nurse, wears all day long and carries with him a paired smartphone that enables motoric symptoms monitoring but not gait assessment, as well as activity (from the smartphone GPS) and sleep monitoring from the band app. Is notified by the admin in case of problems with the data collection. The symptoms analysis is not exposed to the patient.
• Optionally, i.e. if instructed by the prescribing neurologist/ GP/ nurse, wears the insoles for gait assessment.
• Is able to have sessions with psychologists/ psychiatrists, speech and language therapists, dieticians and even sex therapists through a secure video-therapy platform.
• Is educated about how to cope with daily tasks and activities (occupational therapy) and manage speech, language and communication problems as well as eating, swallowing and drooling problems (speech and language therapy).

The prescribing clinician/ nurse/ GP:
• Can see in advance or during the visits, depending on the workload, all historical data (Age, Age at PD onset, Marital status, Occupational status, Living arrangements, Desired lifestyle, Access to caregiver support, Comorbidities, Current and previous prescribed care plans: Pharmacological, Physiotherapy, Nutritional).
• Can see in advance or during the visits, depending on the workload, data for motoric symptoms as evaluated from the smartphone, band and the insole sensors as well as data for activity and sleep as captured from the band.
• Can perform with the patient during the visit all the necessary tests for the evaluation of cognition, speech, QoL etc.
• Visualizes patient’s fluctuations.
• Has patient specific medication, nutrition and physiotherapy adherence data.
• Receives short reports from anyone involved in the management of PD, e.g. psychologists doing online sessions, physiotherapists etc.
• Is provided decision support in the form of:
o Alerts for the overall worsening of the patient and the need for change of medication
o Medication modification suggestions and is able to make necessary adjustments and send it to the patient and the caregiver.
• Modifies the medication plan accordingly.

The supporting clinicians (occupational and speech therapists, psychologists, psychiatrists, physiotherapists-that-do-not–adopt-our-game):
• Have medication, nutrition and physiotherapy adherence data.
• Have data for symptoms and fluctuations and optionally for sleep and activity in case the band was prescribed.
• Have the results/ scores of the cognition, speech, QoL etc. tests prescribed by the prescribing clinician. They can also ask the prescribing clinician to approve schedule a new test.
• Have online video or regular sessions with the patients and/ or caregivers.
• Can perform with the patient on the patient’s smartphone or in the clinician’s desktop app all the necessary tests for cognition, speech, QoL etc. during a visit.
• Prepare short (predefined) reports for the prescribing clinician and longer reports for themselves after each session.

The nutritionist:
• Has a tool for monitoring in structured way Bioelectrical Impedance Analysis (BIA) measurements and biomarkers data.
• Receives information from the interaction of the patient with the mobile app for medication plan compliance, preferred foods, dietary habits etc.
• Receives structured tests results from Nutrition screening (NRS2002), Dysphagia, Food Frequency Questionnaires (FFQ).

The physiotherapist that adopts the PD_manager game:
Has additionally a game that he can use during the sessions with the PD patients.

Anyone that uses the PD_manager Knowledge Management System:
• Has an off-the-self, open source platform for data collection (at least) from the band and the smartphone.
• Has a cloud storage facility (3DNet) where all the gathered data are stored.
• Has a tool for data mining (ClowdFlows) in which the gathered data areo available for further data analysis.
• Has a desktop application with rich visualization and a dashboard with different widgets for working with the data.

Related information

Record Number: 191372 / Last updated on: 2016-11-16
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