Patient information for participation in the CorewayPredict PMCF study

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What is it about?

You are cordially invited to take part in a scientific study (PMFC study) to investigate the safety and performance of the future CorewayPredict app. This app is intended to help predict disease relapses in chronic inflammatory bowel diseases (IBD) such as Crohn’s disease or ulcerative colitis.

Our first study (proof of concept study) is already showing promising results. However, in order to certify CorewayPredict as a Class IIa medical device and make it available to you, data from a certified medical device is required. That is why we are now conducting a second study with our CorewayInsights app (Class I medical device). We are also investigating whether regular use of the app influences your well-being and quality of life.

Who is behind it?

Organiser of the study (sponsor): coreway UG (haftungsbeschränkt), Bischof-Keppler-Straße 9, 73525 Schwäbisch Gmünd, Alemania
Study management: Philipp Emonds, Selina Hörig
Cooperation partners: University of South Denmark, Stuttgart Media University

What can you expect?

Duration of your participation: 3 months

Procedure:

You will receive access to the CorewayInsights app via the App or PlayStore.
In the app you will receive all the important information about the study (see FAQs in the ‘Support’ section) and give your electronic consent (more on this below).
Don’t have your own compatible wearable (e.g. a smartwatch)? No problem, we’ll send you one free of charge. We will send you further information about the rental process separately.
At the end of the registration process, you connect your wearable. This will automatically record various health parameters. It is therefore no longer necessary to enter your HRV value every day compared to the first study.
During the study, you will carry out a short daily check-in via the app. Among other things, you enter how you are feeling, whether you have any symptoms, how you slept and how stressed you feel. The data from your wearable (e.g. your heart rate variability) will continue to be recorded automatically.
At the beginning and end of the study, you will also complete a questionnaire on your quality of life.

Consent in the app – what does that mean?

Before you start the study, you will be asked to give your consent in the CorewayInsights app (see yellow box). This consent is important and required by law. By doing so, you agree:

to participate in the study,
that your data will be processed pseudonymised and used for the scientific evaluation,
that you have understood the conditions of the study.

Important: You can withdraw your consent at any time without giving reasons. Even then you will not suffer any disadvantages. To do so, please contact kontakt@core-way.de .

Please read the following points carefully before you give your consent.
With your consent you declare:

1. Voluntary participation: I understand that participation in the study is voluntary. I can terminate my participation at any time without giving reasons and without incurring any disadvantages.

2. Purpose of the study: I have read and understood the information about the study. I am aware that the purpose of the study is to investigate the safety and performance of the CorewayPredict app for predicting disease flare-ups in IBD.

3.Study procedure: I will participate in the study for a period of 3 months, perform daily check-ins in the app, use a wearable (if possible) and complete a quality of life questionnaire at the beginning and at the end.

4.Data processing: I agree that my health data and wearable data recorded in the app will be stored pseudonymised (i.e. without direct reference to my person) and evaluated for scientific purposes. The data processing is GDPR-compliant.Right of revocation: I am aware that I can revoke my consent at any time without giving reasons. All data collected up to that point will be retained for scientific analysis unless I expressly request its deletion.

5. Risks and safety: I have been informed that participation is associated with minimal risks, as this is a purely observational study. I can report undesirable events at any time via the app.

6. Contact and questions: I know who I can contact if I have any questions or problems: The Coreway study team is always available to help me.

By giving your consent in the app, you confirm that you have read and understood the information about the study.

What is the aim of the study?

Main objective: We want to prove that CorewayPredict can accurately and reliably predict disease relapses in IBD.

Additional benefit: We are also investigating whether regular use of the app can improve your well-being and quality of life.

Can you take part?

Yes, if you:

are at least 18 years old,
have a confirmed diagnosis of Crohn’s disease or ulcerative colitis,
have a compatible smartphone,
are willing to give your consent.

Unfortunately not if you:

are pregnant,
have other serious illnesses (to be decided by the study management)*,
have cognitive impairments.

* Fill in the registration form as normal and state all your medical conditions. If an illness excludes your participation, we will contact you.

What are the risks and benefits?

Advantages: The app gives you a better overview of your illness and your state of health. This can help you to better recognise patterns. At the same time, you are contributing to IBD research and helping us to provide an innovative solution for all IBD sufferers.
Risks: There are hardly any risks, as the study only analyses your information and the data from the wearable. Don’t worry – your data is safe and will be kept strictly confidential. However, please note: The app never replaces medical treatment or a doctor.

What happens to your data?

Your data is processed pseudonymised. This means that your name is replaced by a code so that nobody can deduce your identity. All data will be stored in compliance with the GDPR and used exclusively for this study.

Voluntary participation

Your participation is completely voluntary. You can withdraw from the study at any time without giving a reason – there are no disadvantages for you.

Safety and support

If you notice anything unusual during the study (e.g. undesirable side effects), you can report this at any time via the app. To do this, click on ‘Support’ and contact us via the contact button. Our team will take care of it and get back to you immediately. If necessary, we will then forward the incident to the relevant authorities or the ethics committee.