BRAVO is a clinical trial that is designed to collect your health information and a few drops of blood to better understanding what it means to live with and manage RA. BRAVO is sponsored by the research company, DxTerity. DxTerity researchers are looking to find a better, easier, and more convenient way for people living with RA to track and manage their disease activity.
Everyone’s experience with RA is personal, from your diagnosis to your flare triggers and your treatment. By collecting your unique health history, daily experiences and blood samples, DxTerity is working to personalize the next generation of RA management.
We need engaged and informed people like you wanting to make a difference to join BRAVO and assist researchers in finding and developing the next generation of RA care.
Clinical research is the scientific process that determines the safety and effectiveness of new devices, diagnostics, and medications intended for human use. There are several steps and stages of clinical research and regulatory approval that an investigational product goes through before it can be distributed in the United States.
Companies who make these devices, diagnostics, and medications (also called “investigational products”) can spend many years developing them using laboratory information and clinical information. Translating lab data into clinical outcomes is important to ensure the new device or drug will be safe and effective for patients. Clinical, or patient, information can be collected from approved observational clinical research studies, like BRAVO.
An observational clinical research study, like BRAVO, is a type of clinical research that collects information from volunteers to help scientists better understand a certain medical condition, like RA. This patient information may help develop more effective and safer devices, diagnostics and medications. BRAVO is considered “direct to patient” because we, here at BRAVO & DxTerity, are directly asking people like you to help researchers better understand how RA is managed and how RA affects you daily.
The data you share with BRAVO may directly contribute to our understanding of how people with RA deal with and manage their RA daily, and may help us develop an easier way for RA sufferers to track and manage their disease activity from the comfort of their own home.
Participating in clinical research is an important part of discovering and developing new medicines and ways of treating conditions. Volunteers like you help research move forward. People participate in clinical research for a number of reasons, but one of the most reported reasons is to help other people in the future and to move medical science forward.
BRAVO is studying rheumatoid arthritis (RA) disease activity and management. In order to accomplish this, only people that have been diagnosed with RA by a healthcare professional can participate at this time.
In the future, DxTerity may sponsor new clinical research studies for other medical conditions, for which you may qualify. For now, we thank you for your interest and hope you check back with DxTerity about new opportunities in the future!
DxCollect is a self-collection tube developed by DxTerity to collect and preserve very small volumes of blood for analysis of DNA and RNA. DxCollect is designed to preserve DNA and RNA at room temperature for long periods of time.
Our goals of the research are to develop new diagnostics and treatment options that may enable better management and relief from disease.
Before your first DxCollect kit is mailed to you, you will need to read and sign the consent form. When you sign up, a link to BRAVO’s electronic informed consent form (eConsent) will be emailed to you. Check out the FAQ “What is Informed Consent?” for more information.
Once you provide informed consent, you will get access to a personal and secure BRAVO study portal. In your BRAVO study portal, you will find questionnaires to complete throughout the study. All information you share with us will be secured within the portal for your privacy. After you consent, log in to your portal and fill out the forms to receive your DxCollect kit. It may take up to 30 days for you to receive your first kit.
Informed consent is an essential process in clinical research where by a person is provided all of the facts about a study, for example what procedures and risks may be involved, and decides whether or not to participate. The informed consent process is designed to protect research participants by recognizing your right to know about a study before you decide to participate. The informed consent process is required by law to ensure anyone looking to enroll in a study fully understands (is informed) about the clinical research study they may be in. The process commonly takes place with an Informed Consent Form, which answers questions you may have like:
- What is the study about?
- What will I be asked to do during the study?
- How long will I be in the study?
- Are their possible risks or benefits of participating?
- How will my information be used in the study?
- How will my information be kept private?
- Can I decide not to be in the study later?
- Who can I contact about the study?
Signing an Informed Consent Form means you have learned about and agree to participating in the research study. Consent for clinical research is completely voluntary, and you may change your mind at any time during a study if you no longer feel comfortable participating.
BRAVO has an Informed Consent Form that must be read and signed before you can begin activities in the study. When you sign up, you will be given a link to read and sign the consent form, electronically.
Participating is easy! BRAVO is designed for you to participate from the comfort of your home.
During BRAVO, you’ll be asked to complete questionnaires about your health and medical history. These will be provided to you within your secure BRAVO study portal. You can access this portal using any web browser from your computer or your smartphone.
We will also ask you to self-collect a few drops of blood using our DxCollect kit. Kits will be mailed to your home about every 2 weeks and contain a prepaid return box so you can drop off your completed kit at any USPS mailbox. You will receive a total of 3 kits. After that, your participation in BRAVO will be complete! Check out the FAQ “What is DxCollect” to learn more!
The self-reported health information you share with BRAVO will be used to help BRAVO researchers understand results from your blood samples in terms that translate into daily disease activity and what it means to live with RA. Translating lab data into clinical outcomes is important to ensure new options may be available for patients.
Your data will be coded; this means researchers will not have access to your name or other information that can identify you. Your personal information will be kept in a confidential manner.
Your privacy is very important to us. Information you share during BRAVO is handled and maintain in a confidential manner.
All health information you share with BRAVO will be maintained within your personal and secure study portal. Only you have access to this data outside of the sponsor. Before your data is used for research, information that could be used to directly identify you is removed, so your identity is kept private.
You will not receive any results from BRAVO. BRAVO is an observational clinical study that uses the samples and information gathered to attempt to better understand RA. DxTerity researchers will analyze this data to try to develop an easier, more personalized method of managing RA. Information collected for BRAVO will be used for research.
For your time and participation, you will be compensated up to $25 per activity. At three (3) time points, you will be asked to fill out health questionnaires and provide a fingerstick samples of blood. So, if you complete all of the questionnaires and sample collections, you will be compensated up to $75 for participating.