What is LIFT?
LIFT stands for Lupus Interval Monitoring to Manage Disease Flare and Enable Treatment Optimization and is an observational research study that that uses participant’s health information and a few drops of blood to better understand what it means to live with and manage lupus. LIFT is sponsored by DxTerity Diagnostics, a Los Angeles based genomics company. DxTerity researchers are looking to find a better, easier, and more convenient way for people living with lupus to track and manage their disease activity.
Everyone’s experience living with lupus is personal, from your diagnosis to your flare triggers, and your treatment. By collecting your unique health history, daily experiences, and blood samples from the convenience of home, LIFT is working to personalize the next generation of lupus management, so that those diagnosed with lupus will have the knowledge and power to live confidently.
How do I participate?
Participating is easy! LIFT is designed for you to do from the comfort of home. You do not have to visit a doctor’s office or clinic to participate.
After you click Join Now we will email you a link to your Informed Consent form that gives you more details about the study and what you should expect. During LIFT, you’ll be asked to complete questionnaires about your health and medical history. The questionnaires will be available within your secure LIFT study portal. You can access this portal 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. Kits will be mailed to your home about every two (2) weeks. We’ve already paid the 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 three (3) kits. Check out the FAQ What is the DxCollect® kit? to learn more about the kit!
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 member of LIFT, you will not have to change anything about your daily routine. LIFT is an observational research study designed to collect real world information and samples from participants. LIFT does not test a new drug or device and does not provide medical treatment. Through LIFT, participants have the freedom to be involved in lupus research without having to change anything about the medications they are currently taking or treatment they are receiving.
Why should I participate?
Participating in clinical research is an important part of discovering and developing new medicines and ways of treating diseases. Participants, like you, are the reason medical research moves forward. People join research studies for many reasons, but the most common reason is to help future patients and to move medical science forward. By joining LIFT, you will help contribute to lupus research that may result in better ways of managing 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 LIFT’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 will call you to confirm your shipping address, so we can ship your first DxCollect® kit to the correct address. You can expect your first kit within 3 to 5 business days of confirmation of your shipping address
– You will get access to your secure LIFT study portal. In your LIFT study portal, you will register your kits and answer questions throughout the study.
What is informed consent?
Informed consent is an important process in research. Before beginning a research study, the participant is given information about the study so they can decide 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, but you can stop participation at ANY time if you no longer want to take part in the study.
LIFT 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.
LIFT is an observational research study that does not test a new drug or device and does not provide medical treatment. Observational studies collect information and samples from participants, like you, to support the understanding of medical conditions and development of new products.
What is the DxCollect® kit?
The DxCollect® kit was developed by DxTerity, to be used by participants to collect 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 ship our kits all around the country.
Who is conducting this research?
DxTerity is sponsoring the LIFT study. DxTerity is a Los Angeles-based research company that uses state of the art technologies to analyze DNA and RNA. They also developed the DxCollect® Kit (used in LIFT) for easy at-home collection of fingerstick blood samples. DxTerity will be analyzing the samples and information collected during LIFT to develop a blood test for lupus patients to help monitor disease activity and treatment response.
What is genomics?
Genomics includes the study of how genes interact with each other and with the environment. Genomics looks at both DNA and RNA . Your genomic information can change in response to your disease or from environmental conditions. Genomics can provide information on what is happening in your body right now and why researchers are looking to develop tests using this information.
I don’t have lupus. Can I participate?
LIFT is studying Systemic Erythematosus Lupus (SLE or lupus). In order to accomplish this, only people who have been diagnosed with lupus can participate at this time. 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?
The health information you share with LIFT will be used to help researchers understand results from your blood samples in terms that translate into daily disease activity and what it means to live with lupus. Translating lab data into clinical outcomes is important to ensure new treatment options may be available for patients.
Your data will be de-identified and coded; this means researchers will not have access to your name or other personal information that can identify you. Your personal information will be kept in a private and confidential manner.
Is my information kept private?
Your privacy is very important to us. Information you share during LIFT is handled and maintained in a confidential manner.
All health information that you share with LIFT will be maintained within a secure study database. Before your data is used for research, information that could be used to directly identify you is removed, so your identity is kept private.
Will I get test results?
We will not return lab results or genetic data to you. Information collected for LIFT 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 $75 for completing ALL three (3) DxCollect® kits and required questionnaires. There is no compensation for partially completed study activities. You can choose to either receive your $75 as a Visa rewards card or to have DxTerity donate $75 to a lupus charity.
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 our study. Your medical records will help us to better understand how your health history links with your health condition.