TANDem-2:
Closing the gap to interventions for TAND
Join the TANDem-2 study
Thank you for your interest in the TANDem-2 project! Here you will learn more about this project, how you can join, and how you can access the TAND Toolkit App.
What is the study about?
This study focuses on the neuropsychiatric challenges most people with Tuberous Sclerosis Complex (TSC) experience called TAND. These can be very stressful for individuals with TSC and their families. In our first research study (TANDem-1), we created a self-report quantified TAND Checklist (TAND-SQ) and a mobile app called the TAND Toolkit App. The TAND-SQ Checklist is designed to identify an individual’s unique TAND profile. The app helps by providing the TAND profile summary and further information and helpful tips about TAND.
In TANDem-2, we want to understand how TAND change over time and what might influence these changes. We also want to learn more about caregiver wellbeing and how this is related to TAND severity. To do this we plan to use the TAND-SQ within the TAND Toolkit App to track TAND severity over time in 500 people with TSC!
As the expert in your or your loved one’s TAND, we need your help!
TANDem-2 Study Information and Consent Form
[tandconsortium.org]
Who can join?
You can join the study if you are over 18 and either have TSC yourself, or are a parent or legal guardian of someone with TSC of any age. You can join from anywhere in the world if you understand English enough to complete the English questionnaires and checklists on the TAND Toolkit App.
What will I need to do?
You will need to:
- Register on the TAND Toolkit App.
- Give informed consent to share your information for research.
- Complete questionnaires every 3 months for 1 year (5 times in total).
- Questions will ask about your or your family member’s TSC symptoms, TAND severity, TAND interventions, and your wellbeing.
Who is doing the study and who funded it?
The TAND consortium, led by Prof. Anna Jansen and Prof. Petrus de Vries, is responsible for conducting the study. This project is funded by the Department of Defense (DoD) Tuberous Sclerosis Complex Research Program, and the TSC Alliance. The DoD can review your information for audit purposes but cannot download or keep it.
What happens to my information?
Your information will be protected and stored securely. It will only be used for research purposes. For more information, see the app’s Privacy Policy and Terms of Use.
TAND Toolkit App Privacy Policy
[tandconsortium.org]
TAND Toolkit App Terms of Use
[tandconsortium.org]
What are the risks and benefits?
There are no direct risks for you if you join the study. You will gain insight into your own TAND journey and how your or your loved one’s TAND change over time. You will have access to the TAND toolkit containing suggestions for seeking help for TAND and tips and strategies you can implement at home. You can also download reports of your information to share with your care team. We hope that this study will also help clinicians learn how TAND change over time and how to use this information to improve care.
Can I withdraw from the study?
You can leave the study any time by deleting your account. Your personal identifiable information will be deleted, and the rest of your anonymised information will be kept for research purposes. If you want to delete the information already collected, you will need to request this from the project principal and co-principal investigators, Prof. Anna Jansen (anna.jansen@vub.be) and Prof. Petrus de Vries (petrus.devries@uct.ac.za), with copy to the Data Protection officer at Vrije Universiteit Brussel (dpo@vub.be) before you delete your app user account.
Who approved the study?
This study was approved by:
- Vrije Universiteit Brussel, VUB, Belgium (CE-2024-222)
- University of Cape Town, UCT, South Africa (327/2024)
- Department of Defence Office of Human Research Oversight, USA (E05445.1a)
How do I find out more?
To find out more about the TANDem-2 research project please download and read the following documents:
- TANDem-2 Study Information Form
- Privacy Policy of the TAND Toolkit App
- Terms of Use of the TAND Toolkit App
You may also find an answer to your question(s) in the ‘Frequently Asked Questions’ section below. Feel free to reach out to the TANDem-2 study team at info@tandconsortium.org with any further questions.
TANDem-2 Study Information and Consent Form
[tandconsortium.org]
TAND Toolkit App Privacy Policy
[tandconsortium.org]
TAND Toolkit App Terms of Use
[tandconsortium.org]
How do I join?
If you would like to join the study, please click on the ‘I want to participate in the TANDem-2 project’ button below and you will be directed to the app website. Once you have read the Study Information Form and agreed to the consent statements, and read and accepted the Privacy Policy and Terms of Use in the app, you will be ready to use the TAND Toolkit App!
You don’t need to download the app. The app can be accessed by typing in https://app.tandtoolkit.org in the internet browser of your mobile phone, tablet, iPad, desktop computer, or laptop.
Share your TAND journey with us and contribute to the science of TAND!
Frequently asked questions (FAQs)
Study procedures
You will need to agree that:
- You understand what the study is about.
- You are over 18 and either have TSC or are a parent/legal guardian of someone with TSC.
- You have a good enough understanding of English to be able to complete the app questions in English.
- You are happy to provide information using the app every 3 months for one year.
- You give permission for the TAND consortium to store and use your information for research.
The first time you complete the questionnaires on the app will take about 30 to 45 minutes. Each of the four subsequent timepoints will only take 20-30 minutes as much of your information will be updates only. During data entry rounds 2 – 5, the app will pre-fill your information entered in your previous data entry round, and you can then update it as necessary for your next data entry round.
We are exploring how TAND change over time, and what might affect these changes. So we will ask you to complete the questionnaires five times: every three months over 12 months.
We are working on making the TAND Toolkit App available in a number of languages. However, at the moment, all the questionnaires for TANDem-2 are only available in English.
My study information
The TAND Toolkit App will collect information on your or your family member’s TSC symptoms, TAND severity, TAND interventions and wellbeing. After the first round of information, you will receive reminders via email when it’s time for your next round of information (every three months). You will have a two-week window to complete the information again.
Your information will be stored securely and only used for research purposes. The app Privacy Policy and Terms of Use have more details about this. Only the research team will have access to your information.
You can leave the study at any time by deleting your account in the TAND Toolkit App. Your personal identifiable information will be deleted, and the rest of your information already captured will be stored anonymously for further research. If you also want to delete the information you have already given, you will need to contact the project principal investigators and copy the Data Protection Officer with this request before deleting your account.
Risks, benefits and what to do if I am not feeling well
You will learn more about how your or your loved one’s TAND change over time. The app will generate helpful charts of these changes. You can download the completed questionnaires and charts to share with your doctor. You can access the tips and strategies in the TAND toolkit to help you with your TAND.
There are no direct risks to joining the study.
The information you put into the TAND Toolkit App is not monitored in real time. So, if you are not feeling well or you experience a change in symptoms, please contact your doctor or medical care team.
Technical / App issues
Click on the ‘Register here’ button at the top of the https://tandconsortium.org/join-tandem-2 webpage, or go to https://app.tandtoolkit.org. You will be directed to a secure webpage where you can register to use the app. After your registration has been completed and you have confirmed your email address, you can log in and start using the TAND Toolkit app.
You don’t need to download the app. You can access the app by typing in https://app.tandtoolkit.org in the internet browser of your mobile phone, tablet/iPad or laptop/computer.
The app asks you to enter your email address and password during the login process. There is no additional username required. If you forgot your password, on the login page you can click on ‘Forgot your password’ and then enter your email address, you will then receive an email with a link where you can create a new password.
You can access the app from any device by entering the webpage address in your internet browser. Your information will not be lost if you lose your device.
You can update your personal information at any time. The responses to questionnaires cannot be edited in the app after submitting the questionnaires as complete. However, if you would like to correct any information already captured, you can submit a request to the project principal investigators, Prof. Anna Jansen (anna.jansen@vub.be) and Prof. Petrus de Vries (petrus.devries@uct.ac.za), and copy the Data Protection Officer at Vrije Universiteit Brussel (dpo@vub.be) with your request. You can also click on ‘Contact us’ in the app and report your problem.
Contacts
For general questions about the study, please email the team at info@tandconsortium.org. You can also contact the study principal investigator Prof. Anna Jansen (anna.jansen@vub.be) or co-principal investigator Prof. Petrus de Vries (petrus.devries@uct.ac.za).
If you encounter a problem while using the app, or have any technical questions about the app, you can click on ‘Contact us’ in the app and report the problem.
For questions about your information or to delete your information, you can contact the study principal investigators, Prof. Anna Jansen (anna.jansen@vub.be) and Prof. Petrus de Vries (petrus.devries@uct.ac.za), and copy the Data Protection officer at Vrije Universiteit Brussel (VUB) dpo@vub.be with your request.