Stanford University researchers are recruiting ME/CFS, Chronic Lyme, and Long COVID patients for a study to better understand symptom flares such as post-exertional malaise (PEM), or “crashes”.
About the Study
The Crash Course aims to understand and predict relapses, flares, and crashes in chronic disease. To be eligible, you must live in the US, be over age 18, and experience relapse episodes persisting at least 24 hours in duration.
Additionally, you must experience one of the following conditions:
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
- Chronic Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS),
- or Long COVID or Post-COVID Syndrome
WHAT THE STUDY INVOLVES
Fill out online questionnaires
Collect fingerprick blood samples at home
Use provided devices to measure sleep, activity, blood pressure, and heart rhythm
Compensation:Participants will receive a $25 Amazon gift card after completion of the study.
Please email firstname.lastname@example.org
for enrollment information.
Participant’s rights questions, contact 1-866-680-2906.
A Fitbit smartwatch, microsampling kit, and S-patch cardio device will be provided to you. You will be asked to return the devices at the end of the study. No charge will be applied if the devices are lost or broken.
FREQUENTLY ASKED QUESTIONS
Who can participate?
People who are 18 years or older with a diagnosis of ME, or ME/CFS; Long COVID; or Chronic Lyme Diseaseor Post-Treatment Lyme Disease Syndrome can participate. Only people in the United States may participate at this time.
You will have to upload a document from a medical provider confirming your diagnosis. The exception is Long COVID, which is still very rarely diagnosed by clinicians. We ask that Long COVID responders have had a positive PCR or antibody test for COVID-19 or met the CDC criteria for suspected COVID-19 infection, and have continued to experience symptoms for 3 months or longer. Your doctor does not need to have told you that you have a diagnosis of Long COVID (or “PASC”).
There are also pre-screening questions that will determine if you qualify to participate.
What is the purpose of the study?
People with chronic complex diseases like ME, Long COVID and Chronic Lyme experience many changes in their wellness over time. People with these diseases may call periods of worsened illness a ‘crash’, ‘flare’, or post-exertional malaise (PEM).
In this study, we will examine changes in your blood when you are experiencing worsened function and on days where you are feeling relatively better. We will also ask you to collect samples at regular intervals to
create a baseline. In addition, we hope to use wearable devices, including Fitbits and in order to predict and help prevent crashes, flares, and PEM. In addition, we hope to better understand the mechanisms of disease fluctuations, which may lead to diagnostics and treatments.
Is there any reimbursement for participating in the study?
Yes, you will receive a $25 Amazon gift card for your participation. This is a small thank-you for your effort on this study.
What is a crash, flare, or post-exertional malaise?
A flare is exacerbation of chronic illness symptoms. Post-exertional malaise, sometimes called a ‘crash’ is a
sudden and significantly worsened function and may be considered more specific to ME, ME/CFS, and Long
COVID often as a result of physical activity.
How long will the study be open?
The study will be open for up to two years. Participants will be asked to gather samples over the course of three months. If you are willing and able to keep participating, you may request to continue gathering samples for up to one year by contacting our study coordinator at email@example.com.
What will participants be asked to do?
1. First, participants will go through the consent process.
2. Participants who meet inclusion criteria will receive a kit by mail that contains everything they need to participate (at no additional cost to you), including microsampling kits, a Fitbit smartwatch, and a Wellysis S-patch Cardio device.
3. Participants will then download the apps to use these devices onto their Android or Apple phone. You must have access to an Android or Apple phone to participate.
4. Participants will wear a Fitbit device to keep track of their heart rate, daily step count, and other variables.
5. Participants will be asked to fill out six daily questions about their well-being; links will be sent via email each day.
6. On some days, participants will take a blood microsample:
a. Every two weeks, to develop a baseline
b. Three samples on days that feel better than average
c. Six samples on days participants are experiencing a crash, flare or post-exertional malaise
7. On collection days, participants will also wear the S-patch Cardio device all day.
8. On collection days, participants will complete a longer questionnaire about their current symptoms.
9. When participants have collected all of their samples, they will put them into the provided mailing envelope to return to us at Stanford.
10. Participants will receive an Amazon gift card in return of their first 16 samples and study kit materials,
including your Fitbit and S-patch Cardio.
11. PLEASE NOTE: If you choose to collect another 16 samples while the study is still underway, you may ask to receive a second, complete kit, and a second Amazon gift card once you return your second set of 16 samples and your study kit materials.
What if I collect more than the required 16 samples?
After you are done with the ‘first round’ (baseline samples every other week, six ‘crash’ days and three ‘good’ days), you may choose to send your first set of 16 samples and study kit materials, including your Fitbit and S-patch Cardio back to Stanford. After doing so, you may request additional sampling kits to continue your participation (for no more than 1 year) by contacting firstname.lastname@example.org.
Do my crashes or PEM ‘count’ if they are not induced by activity?
Crashes can be induced by more than activity alone. We are interested in observing the metabolomic changes caused by crashes, flares, or PEM in general. It is okay to take samples anytime you are in a crash, no matter what may have caused it.
What if I don’t have enough ‘good’ days?
We recognize that people with chronic complex diseases may not have days where they ever feel truly well. Samples collected on ‘good’ days are good only relative to your average wellness. If you experience a day where your symptoms ease somewhat, consider this to be a ‘good’ day.
If you still are unable to collect samples in any of the categories, please see ‘what if I don’t collect all 16 samples’ below.
We will use data from your blood to study whether different biomarkers are produced when you are experiencing a flare, a crash, or post-exertional malaise (PEM) versus when you are feeling better. In order to do so, we are performing ‘multi-omic analysis’, meaning we will analyze over a thousand different molecules in the blood. We hope to use this data to predict whether someone is likely to have flares, crashes, or PEM, and what causes these symptoms.
How will you ensure my data stays private?
All data will be stored securely on RedCap or Stanford Medicine Box. Only Stanford personnel with training in data protection and who are associated with the study will have access to your data. Data is encrypted,
firewalled, and ‘personal identifiers’ (like your name) are stored separately from any data we get from the study (like your metabolomics).
In the future, other researchers might get ‘raw’ data from this study, but they will never have access to any ‘personal identifiers’, just the data we get from performing the study.
What if my survey link isn’t working, or I have not received my survey link?
If you have not received your survey links, please reach out to the study coordinator as soon as possible at email@example.com.
This data is important to capture while you collect your samples.
What if I lose / don’t receive my sample kit?
If you lose/do not receive your sample kit, please reach out to the study coordinator at
firstname.lastname@example.org to help you with the next best steps.
How long should it take between signing up and hearing back from recruitment?
We will review the information you have provided to us to ensure your eligibility in the study. We ask for your patience and understanding, and hope to get back to you within 2 weeks of receiving your submission.
When should I receive my Amazon gift card?
Once your complete set of 16 returned samples and your returned sample materials, including the Fitbit and
S-Patch Cardio, are received back at Stanford, you will receive your Amazon gift card for $25 within ~1 week. At that time, you may choose to ask for a second complete kit to begin the process again.
What if I am unable to collect 16 samples?
If we have reached the end of the study and have been unable to collect all 16 samples, reach out to us at email@example.com and let us know. We may still be able to use the samples you have collected.
What do I do if my question wasn’t addressed here?
Please reach out to the research team at firstname.lastname@example.org. We are happy to help answer any questions you may have, and provide you with any support you may need.
Reach out to us if you are interested in learning more about the Crash Course Study:
RESEARCH TEAM AND COLLABORATORS
Postdoc, Snyder Lab
Linda (Yu-Ling) Lan
Postdoc, Snyder Lab
Clinical Research Coordinator Associate (CRCA) , Snyder Lab
Researcher at SGTC, Director of Scientific and Medical Outreach, #MEAction
Study Design, Patient Recruitment
Research Fellow, University of Melbourne
Director of the Melbourne ME/CFS Collaboration
Study design, data analysis and interpretation