TANDem-2:
Closing the gap to interventions for TAND
About the TANDem-2 study
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 ‘Register here’ 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!
