The first research data collection study of the project

The GData study takes place in the United Kingdom, Germany, Portugal and Greece via the iPrognosis application available on the Google Play Store. Learn more about the study by reading the general information provided below in English; you can navigate through the different sections using the links below. If you prefer to read the information in your language, click on the corresponding country below.

 

Country-specific Participant Information Sheet and Consent documents

 

UK
UK
GR
Greece
DE
Germany
PT
Portugal

 

General information

 

TABLE OF CONTENTS

Parkinson’s disease About the project About this study
Aim of study and participants What data will be collected Risks, benefits and public involvement
Organisation, funding and review Withdrawal and problems Data confidentiality, protection and storage
Questions

 

INTRODUCTION

The iPrognosis app is part of a data collection study of the i-PROGNOSIS European research project that aims to develop early Parkinson’s disease detection methods.

 

PARKINSON’S DISEASE

Parkinson’s disease is a slow progressive condition, with a usual onset in the middle to older age. It presents with motor symptoms (such as tremor of the hands and arms, stiffness of the muscles and slowness of movements) and non-motor symptoms (such as sleep problems, pain, changes in mood, constipation and olfactory disturbances).The disease can be treated symptomatically by multidisciplinary care including medication and supportive therapies, but cannot be cured. Despite our knowledge that some symptoms can predate the diagnosis for years, no specific system exists for earlier detection of the disease when prodromal symptoms start to develop.

 

ABOUT THE PROJECT

The European Horizon 2020 research project, titled i-PROGNOSIS, aims to collect data from a wide participant group including healthy volunteers and patients with Parkinson’s disease in order to develop tests for the early detection of Parkinson’s disease. The research focuses on the early identification of specific symptoms (motor and non-motor) which could accelerate a clinical diagnosis of the disease. Furthermore, the project will develop strategies to help improve and maintain the quality of life of patients with Parkinson’s.

 

ABOUT THIS STUDY

How this study works?

With the iPrognosis app, we would like to obtain data from your interaction with your smartphone. These general data, namely GData, comprise analyses of speech, movement, and non-motor symptoms like mood. They were identified based on our existing knowledge of motor and non-motor symptoms of Parkinson’s. To participate in this study, you will be asked to provide electronic informed consent. Following this, the iPrognosis app will run on your smartphone, silently in the background, free of charge and will capture your use and interaction with your smartphone during daily activities. This will not interfere with how you would normally use your phone or its daily functioning.

(Not applicable in Portugal) At some point during the study, our medical partners may contact you regarding a study follow up. You can opt out from this during the consent process. For you personally, there might be a benefit being contacted by our medical partners as, if possibly motor and non-motor symptoms not yet noticed by yourself, are detected by the app. If you agree with being contacted by the app, an individual medical evaluation in one of the i-PROGNOSIS medical centers is offered. Hereby any detected symptoms are controlled and evaluated by a movement disorders specialist based on state of the art medical knowledge as well as any findings explained to you. Hereby, any wrong conclusions are avoided.

How long does the study last?

The GData collection period lasts from April 2017 to October 2019. So if you are happy, you can be active the full time but you do not have to. You can withdraw your consent at any point in time and stop participation and further data collection by selecting the ‘Withdraw’ option of the Consent section in the app Settings.

 

AIM OF STUDY AND PARTICIPANTS

What is the aim of the study?

The aim of this study is to investigate whether the data collected can help to identify patterns that are associated with already known motor and non-motor symptoms of Parkinson’s. The data gathered from this study will help to develop an optimized app and corresponding computer programs which can recognise changes in behaviour related to motor and non-motor symptoms, which might be indicative of early Parkinson’s.

Who can participate?

Healthy volunteers or patients with early Parkinson’s disease between the age of 40 and 90. We expect that approximately 1,000 people will take part across the UK, Germany, Portugal and Greece.

Do I have to take part?

No. It is up to you to decide whether or not to take part and you can withdraw from the study at any time without giving any explanation.

 

What data will be collected

The first time you use the app, we will ask you if you are healthy, have a family history of Parkinson’s or if you have been diagnosed with Parkinson’s. We will also ask you for your date of birth, your gender, your level of education and how long you use a smartphone.
Thereafter, the GData captured in the background by the iPrognosis app include:
• Characteristics of your voice when making a phone call. The personal content of your call is never stored.
• How steady you hold your phone during calls or typing, using device sensors, such as the accelerometer.
• Keystrokes-related data when you type using the iPrognosis Keyboard. What you type is never recorded.
• The distance you covered each day, if you have location services activated and carry your phone around.
• Emotional content from your stored text messages. The content of your messages is not stored.
• Facial expressions from your stored photos. Photos never leave your device.

You can change which data are recorded in the app Settings.

 

RISKS, BENEFITS AND PUBLIC INVOLVEMENT

What are the possible benefits of taking part?

By participating in this study you will be contributing to a European Horizon 2020 project which is likely to develop an app to help early detection of Parkinson’s. This could improve the management of Parkinson’s and the development of future neuroprotective treatments. This study might also offer wider benefits to society and those with similar conditions.

What are the possible risks of taking part?

There are unlikely to be any disadvantage or risks by participating in the study.

How patients and the public have been involved in the study?

This study has been extensively reviewed by patients, Parkinson’s experts and members of the public throughout Europe.

United Kingdom

In the UK, this review included an evening multidisciplinary team group clinic at King’s College Hospital NHS Foundation Trust as well as an expert patient group called ‘Community for Research Involvement and Support by people with Parkinson’s’ (CRISP).

Germany & Greece

In Germany and Greece, this review included focus groups with patients and health experts.

 

ORGANISATION, FUNDING AND REVIEW

Who is organising and funding the study?

The study is performed in Europe with three i-PROGNOSIS medical centres being involved in Greece, Germany and the UK.

United Kingdom

In the UK, the study is led by Professor Ray Chaudhuri and his research team at King’s College London.

Germany

In Germany the study is led by Professor Heinz Reichmann and his research team at the Neurology Clinic of the Technical University of Dresden.

Greece

In Greece the study is led by Professor Sevasti Bostantjopoulou and her research team at the Aristotle University of Thessaloniki, Greece.

Portugal

In Portugal the study is led by Professor José Alves Diniz and his research team at the Faculdade Motricidade Humana, Universidade de Lisboa, Portugal.

i-PROGNOSIS project, part of which is this study, is coordinated by Professor Leontios Hadjileontiadis and his research team at Aristotle University of Thessaloniki, Greece. The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number No 690494.

Who has reviewed this study?

This is an Horizon 2020 grant which is one of the most prestigious grants awarded by the European Union. Currently, one in 20 such grant applications are successful. The grant process goes through a long and rigorous review of the methodology, statistics and aims. There is a stringent security protocol for all data collected.

United Kingdom

Furthermore, all research in the UK is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by the Research Ethics Committee of King’s College London. It has been approved by the Health Research Authority and each local hospital will also give confirmation that the study can go ahead.

Germany

This study has been reviewed and given favourable opinion by the Research Ethics Committee of the Technical University Dresden, Germany.

Greece

This study has been reviewed and given favourable opinion by the Bioethics Committee of the Medical School of the Aristotle University of Thessaloniki, Greece.

Portugal

This study has been reviewed and given favourable opinion by the Research Ethics Committee of the Faculdade Motricidade Humana, Universidade de Lisboa, Portugal.

 

WITHDRAWAL AND PROBLEMS

What if I want to withdraw from the study?

You can withdraw your consent at any point in time and stop participation and further data collection by selecting the ‘Withdraw’ option of the Consent section in the app Settings. By uninstalling the application, further data collection will cease, but any data that you have already provided in the study will be kept. These data will still remain anonymous.

What if there is a problem?

If you have a concern about any aspect of this study, you can contact the i-PROGNOSIS project helpdesk via email at:
info@i-prognosis.eu

If you have remaining queries please feel free to contact:

United Kingdom

Professor Ray Chaudhuri
Neurology Department, King’s College Hospital
Telephone: 0203 299 8336
E-mail: kch-tr.PDresearch@nhs.net

Germany

Professor Heinz Reichmann

Klinik und Poliklinik für Neurologie, Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
Telephone: 0351 458 3565
E-mail: iprognosis@ukdd.de

Greece

Professor Sevasti Bostantjopoulou
Third Neurological Clinic, Aristotle University of Thessaloniki
Telephone: 0030 2310 307 330
E-mail: bostkamb@otenet.gr

Portugal

Professor José Alves Diniz / Dr. Sofia Balula Dias
Faculdade de Motricidade Humana, Universidade de Lisboa
Telephone: 00351 214149116
E-mail: jadiniz@fmh.ulisboa.pt / sbalula@fmh.ulisboa.pt

You can access this info in the Help and feedback section of the app.

(UK only) If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints procedure by contacting your local Patient Advice Liaison Service (PALS) office. Details of your local office can be obtained by asking a study doctor, GP, telephoning your local hospital or looking on the NHS choices website: www.nhs.uk

 

DATA CONFIDENTIALITY, PROTECTION AND STORAGE

Will my data be kept confidential?

We will protect your data to the best of our ability. Your data will be encrypted on your phone and your name will be replaced with a coded ID and therefore your data will be pseudo-anonymised. Neither your name nor your phone number will be used in any reports about the project.

Where and for how long will my data be stored?

The pseudo-anonymised data will be sent on secure Microsoft Azure cloud servers of Microsoft data centres located in Europe. The data will be stored there for at least three years. Microsoft Azure platform is one of the most compliant with international and European regulations for data exchange and storage. Upon the end of the Azure subscription, data will be downloaded on Aristotle University of Thessaloniki (Greece) secure servers of the Department of Electrical and Computer Engineering and they will be stored there indefinitely.

Who has access to my data?

Access to pseudo-anonymised data will be allowed to:
• The principal investigator and sub-investigators of the study as well as specific members of the i-PROGNOSIS consortium for scientific analyses and publication of the results.
• The responsible Research Ethics Committee, if this is a need for inspection of correct project procedures.
• Third party researchers, after they were given license by the principal investigator, for non-commercial research analyses and publications.

Who is responsible for data protection?

Microsoft Innovation Center Greece is the general responsible for data protection and the monitoring of good practices in terms of data management by the rest of the i-PROGNOSIS members.

 

QUESTIONS

Thank you for considering taking part in this study and taking the time to read this information. Should you want further information about the study please contact:

United Kingdom

Professor Ray Chaudhuri
Neurology Department, King’s College Hospital
Telephone: 0203 299 8336
E-mail: kch-tr.PDresearch@nhs.net

Germany

Professor Heinz Reichmann

Klinik und Poliklinik für Neurologie, Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
Telephone: 0351 458 3565
E-mail: iprognosis@ukdd.de

Greece

Professor Sevasti Bostantjopoulou
Third Neurological Clinic, Aristotle University of Thessaloniki
Telephone: 0030 2313 307 330
E-mail: bostkamb@otenet.gr

Portugal

Professor José Alves Diniz / Dr. Sofia Balula Dias
Faculdade de Motricidade Humana, Universidade de Lisboa
Telephone: 00351 214149116
E-mail: jadiniz@fmh.ulisboa.pt / sbalula@fmh.ulisboa.pt

Anywhere

The i-PROGNOSIS project
info@i-prognosis.eu