RoGer TB
Information for patients and consent form
Title of the study
RoGer-TB - TB Companion - Feasibility study on the use of the digital therapy companion TB Companion in cross-border tuberculosis management between Romania and Germany (RoGer-TB).
Study management
Brit Häcker, MD.; Ralf Otto-Knapp, MD. DZK - German Central Committee against Tuberculosis e.V.
Contact
DZK - German Central Committee against Tuberculosis e.V.
Walterhöferstr. 11, Haus Q
14165 Berlin
Germany
Phone : +49 (0)30 81 49 09 22
E-Mail : info(@)dzk-tuberkulose.de
Dear patient,
You are suffering from tuberculosis and have heard about our study. Within this study, you will be one of the first to get the opportunity to try out the new application "TB Companion". The app is designed to help you better understand your disease and guide you through your therapy. The app does not replace contact with your treating doctors or the health department; but is intended to complement them. Whether you participate in the study or not has no influence on the treatment you receive. Your data will be evaluated anonymously. The data will not be passed on to persons not involved in the study or to German authorities. For further information on the study, please see the explanations below and the general data protection policy of the app.
Aim of the study project
Our study is part of a larger project with the short title RoGer-TB within the framework of the Global Health Protection Programme (GHPP). The aim of this project is to improve the treatment and care of Romanian tuberculosis patients in Germany and Romania and to support you in your therapy.
What is tuberculosis?
Tuberculosis is an infectious disease caused by the bacteria called Mycobacterium tuberculosis, which is transmitted by inhaling droplets containing the bacteria. The lungs are most commonly affected, but tuberculosis can also develop in all other organs.
Tuberculosis should always be treated with drugs, otherwise the disease can worsen and lead to sequelae and even death. If tuberculosis is recognized and treated quickly, one can be completely cured. It also helps to prevent further transmissions.
The treatment is a combination of at least 4 different medicines. These must be taken daily for at least six months. The exact combination and duration of your therapy will be determined by your treating doctors based on your results. If you stop the therapy too early or take it irregularly, you may have a relapse, or the medication used may not work anymore. The tuberculosis would then be less treatable.
Who is the TB Companion?
The diagnosis of tuberculosis can be a shock for many people affected, and coping with the long treatment can be challenging. The TB Companion is an application that gives you a lot of information about your disease in a playful way. A virtual companion supports you through the therapy.
Within this newly developed app, the Companion will interactively provide you with knowledge about different aspects of tuberculosis, such as diagnosis and therapy of the disease. The special features of the German health system such as reporting by name, isolation and examination of contact persons are also explained. The Companion will ask you many questions about these topics and can thus compile appropriate information for your situation.
Your Companion can also remind you to take your daily medication. It is also possible to save documents such as X-rays or other findings on your smartphone within the app, so you always have your documents at hand when you need them.
What is the aim of the study?
The study is a proof-of-concept study. The aim is to test whether and how the newly developed TB Companion application is used by tuberculosis patients and whether it helps to improve therapy. The application was developed for tuberculosis patients and now we are interested in your experience with its use. This may require a short survey and your usage data will be analyzed anonymously.
Do I have to participate in the study? Can I withdraw from the study?
There is no obligation to participate in the study. You can withdraw from the study at any time without giving a reason. Regardless of this, you should definitely continue your tuberculosis therapy as planned. You can also use the app without participate in the study. Should you discontinue your participation from this study or delete the app, this will also delete your data. Before the final deletion, we are interested in the reasons for this and will ask you for voluntary feedback.
What data will be collected from me?
The entry of all your personal data is voluntary. Your data is used to control the functionality of the TB Companion and to provide you with information tailored to your personal situation. For this purpose, you will be asked to enter your country of birth, country of residence, age, gender and marital status. In addition, you will be asked in the dialogue with the app to provide health-related data on your tuberculosis disease, your symptoms, the diagnosis made and your current therapy. You will also be asked about concomitant diseases such as HIV or pregnancy.
The entry of all your personal data is voluntary. If you consent to this within the application, the app can also record your location. All this data is encrypted and transmitted anonymously.
How do you process and use my data?
Your data is transmitted to a central database where it is stored anonymously. The transmission of your data is encrypted. Your login data is stored separately from personal data; it cannot be used for tracing purposes. If you save documents or medical findings containing your name or address in the DocsBox function of the app, these documents are only saved locally on your end device and will not be transmitted.
Your anonymized data is used to select a suitable dialogue sequence for you and to be able to use certain functions such as the medication reminder function. The data will also be used to help answer scientific questions of this study.
Who has access to my data?
Only people involved in the study have access to your anonymized data. Access is for scientific analysis and subsequent publication of the data only; use for commercial purposes is not permitted. Your data is not passed on to third parties.
Where and for how long is my data stored?
All the data submitted is stored on local servers in Germany at GE-MU Systems (Neumünstersche Straße 26, 20251 Hamburg). The study administration, together with the above-mentioned company, ensures that the processing of personal data is secured according to current technical standards. The data will be stored for the period of time required for the scientific evaluation and will then be permanently deleted.
How can I delete my data?
You have the possibility to delete all your data at any time without giving reasons. This is possible by uninstalling the app or deleting the profile in the app. Without exception, all data will be permanently deleted from the local database on your phone as well as from the central database.
Consent to study participation
I have read and understood the information about the RoGer-TB - TB Companion study. Before and during the use of the application, I will have the opportunity to ask any questions about the study via a contact form. My questions will be answered in Romanian by the study management through a translator. I voluntarily consent to participate in the study. I am aware that personal data will be processed in this study. The data will be processed in accordance with legal regulations and requires the following declaration of consent in accordance with Art. 6 (¹) of the General Data Protection Regulation: I have been informed and voluntarily consent that my data collected in the study/application, in particular information about my health1, may be stored in anonymized form for the purposes described in the patient information and evaluated by the study management. Third parties will not be given access to personal data. My name will also not be mentioned when the results of the study are published. The personal data will be anonymized, stored and deleted after completion of the data evaluation. I can revoke this consent in writing or verbally at any time without giving reasons and without incurring any disadvantages. The legality of the data processing carried out until the revocation is not affected by this. In this case, I can decide whether the data collected from me should be deleted or may continue to be used for the purposes of the study.
¹ According to Art. 9 (1) of the GDPR, health data are special category personal data, the processing of which requires the explicit consent of the study participant. The same applies to data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs or trade union membership, as well as to the processing of genetic data, biometric data uniquely identifying a natural person, data concerning sex life or sexual orientation.
