What is EMPOWER?

EMPOWER stands for Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response and is an observational research study that uses participant’s health information and a few drops of blood to better understand what it means to live with and manage Multiple Sclerosis (MS). EMPOWER is sponsored by DxTerity, a Los Angeles based genomics company. DxTerity researchers are pursuing a more convenient way for people living with MS to track and manage their disease activity.

Everyone’s experience living with MS is impacted by their unique body chemistry, from diagnosis and disease relapses to response to various treatments. By collecting your personal health history and blood drop samples from the convenience of home, EMPOWER is working to personalize the next generation of disease management, so that those diagnosed with MS will have the knowledge and power to live life confidently.

How do I participate?

Participating is easy! EMPOWER is designed so you can complete study activities from the comfort of home. No trips to a doctor’s office, blood lab or clinic!

After you click Join Now we will email you a link to your Informed Consent Form that provides more details about the study and what you should expect. During EMPOWER, you’ll be asked to complete surveys about your health and medical history. These surveys will be available within your secure EMPOWER study portal, which can be accessed at any time using a web browser from your computer, tablet, or smartphone.

We will also ask you to collect a few drops of blood using our DxCollect® Fingerstick kit, which will be mailed to your home. We’ve already paid the return postage, so all you need to do is drop your kit off in any US Postal Service (USPS) mailbox. You will receive a total of one (1) kit. Check out the FAQ What is the DxCollect® kit?  to learn more!

You will also have the option to allow the study to review your medical records. Once you join, we will provide you a link where you can access your Medical Records Release form.

Will I need to change my current medications or treatment plan to participate?

No! As a participant in EMPOWER, you will not have to change anything about your medications, treatment plan or daily routine. EMPOWER is an observational research study designed to collect real-world information and a fingerstick blood sample from participants. EMPOWER does not test a new drug or device and does not provide medical treatment. Through EMPOWER, participants have the freedom to be involved in MS research without having to change anything about the medications they are currently taking or treatment they are receiving.

Why should I participate?

Patient participation in clinical research is a critical part of discovering and developing new treatments and ways of monitoring diseases. Participants, like you are the reason medical research can move forward. By joining EMPOWER, you will contribute to MS research dedicated to finding better ways to manage the disease.

I signed up. Now what?

Before your first DxCollect® kit is mailed, you will need to read and sign the Informed Consent Form. When you click Join Now a link to EMPOWER’s electronic Informed Consent Form (eConsent) will be emailed to you. Check out the FAQ What is Informed Consent? for more information.

After you submit the eConsent:

– We may call you to confirm your shipping address, then ship your first DxCollect® kit. You can expect your first kit within 1-2 weeks of confirmation of your shipping address.

– You will be given access to your secure EMPOWER study portal, where you will register your kit and answer survey questions throughout the study.

What is informed consent?

Informed Consent is mandatory for participation in research studies. Before beginning a research study, participants are given complete information about the study, so that they can make an “informed” decision about whether to join the study or not. The Informed Consent process is required by law and designed to protect participants, like you, by telling you about a study before you decide to join. A consent form answers questions you may have, such as:
– What is the study about?
– What will I be asked to do during the study?
– How long will I be in the study?
–  Are there possible risks or benefits to participating?
–  How will my information be kept private?
– If I start the study, can I decide not to be in the study later?
– Who can I contact about the study?
Signing a consent form means you agree to participate in the study. However, you can stop participation at ANY time if you no longer want to take part in the study.
EMPOWER has a consent form that must be read and signed before you can begin the study. When you click Join Now you will be emailed a link to read and sign the consent form online.

What is the difference between a clinical trial and an observational research study?

A clinical trial is a scientific process that studies the safety and usefulness of new devices, diagnostics, and drugs intended for people. Clinical trial patients are given the drug or device to determine if it works as planned.

An observational research study collects information and samples from participants to support the understanding of medical conditions and development of new products. EMPOWER is an observational research study, therefore does not test a new drug or device and does not provide medical treatment.

What is the DxCollect® kit?

The DxCollect® kit was developed by DxTerity, to be used by study participants for collection of small amounts of blood for DNA and RNA analysis. The DxCollect® is designed to preserve DNA and RNA at room temperature for long periods of time, allowing us to utilize our kits all around the country.

Who is conducting this research?

DxTerity is sponsoring the EMPOWER study. DxTerity is a Los Angeles-based patient-centric genomics company that uses state of the art technologies to analyze DNA and RNA. They also developed the DxCollect® Kit for easy at-home collection of fingerstick blood samples. DxTerity will be analyzing the samples and information collected during EMPOWER to develop a blood test for Multiple Sclerosis patients to help monitor disease activity and treatment response.

What is genomics?

Genomics studies look at how your genes — DNA and RNA — interact with therapies and the environment. While your DNA generally stays the same throughout your life, your RNA can change in response to your disease or from environmental conditions and provide information on what is happening in your body right now. This real-world biological information from RNA can help researchers develop tests to monitor your disease and determine the best way to treat it.

I don’t have Multiple Sclerosis (MS). Can I participate?

EMPOWER is studying Multiple Sclerosis (MS). In order to accomplish this, only people who have been diagnosed with MS can participate at this time. A diagnosis of Relapsing Remitting MS, Primary Progressive MS and Secondary-Progressive MS qualifies for the study. In the future, DxTerity may sponsor new research studies that you may qualify for. We encourage you to check back with DxTerity about future studies!

What will happen to my information and samples?

EMPOWER researchers will use genomic analysis to develop an at-home blood test to help doctors monitor MS disease activity and treatment response. The information you share, along with your medical record information, helps researchers interpret the genomic results from fingerstick samples in clinical terms.

Your information and samples will be de-identified and coded; this means researchers will not have access to your name or other information that can identify you.

Is my information kept private?

Your privacy is very important to us. All health information that you share with EMPOWER will be maintained in a confidential manner. Before your data is used for research, it will be de-identified and coded, so that researchers will not have access to your name or other personal information that can identify you.

Will I get test results?

We will not return lab results or genetic data to you. Information collected for EMPOWER will be used for research only and participant-specific information will not be provided.

Will I get paid?

For your time and participation, you will be paid $50 for completing one (1) DxCollect® kit and required surveys. There is no compensation for partially completed study activities. You can choose to either receive your $50 as a Visa Rewards card or to have DxTerity donate $50 to a Multiple Sclerosis charity. It will take 4-6 weeks after you complete the study for your rewards card to be delivered in the mail.

Does it cost anything?

No, there are no costs to you.

Why do you need my medical records?

Researchers will use the information from your medical records to confirm the results of the study. Your medical records will help us to better understand how your health history links with your health condition.

Is there information I can bring to my doctor so that I can discuss this study with them?

You can print the Informed Consent Form to take to your doctor, as well as direct them to this website, www.EMPOWERStudyMS.com. You and your doctor are welcome to contact EMPOWER at support@empowerstudyms.com if you have any additional questions about the study.

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