To further characterize Long COVID-19 by collecting data from individuals who already ownwearable devices or are provided with a wearable device along with basic and enhancededucational materials to determine if both can improve Long COVID-19 symptom managementand post-exertional malaise.
This study will have two components:
One study group will consist of up to 100,000 individuals who own wearable devices and
are willing to share their data. These participants will be randomized and will receive
educational materials. The investigators will study these dynamic wearable data along
with participant survey responses that focus on diagnoses, symptoms, and quality of life
to improve disease characterization and understanding of differences within and between
individuals.
The other group in the randomized trial will participants who do not already own a
wearable device. The study will distribute wearable devices and pacing educational
materials to 500 individuals who do not already own them and experience post-exertional
malaise, or the worsening of symptoms following exertion.
The investigators hypothesize that access to personalized information from a wearable
device will enable participants to reduce post-exertional malaise. The investigators will
include up to 25% individuals whose post-exertional malaise is caused by a condition
other than Long COVID-19.
Device: Wearable device
The treatment group will receive their wearable device and the enhanced education at the
start of the study. Their outcomes will be compared with the control group who will
receive at 3 months.
Other Name: Educational materials
Inclusion Criteria:
- Is at least 18 years old.
- Has a self/and or physician diagnosis of:
- Long COVID (based on the WHO working definition),
- ME/CFS (myalgic encephalomyelitis / chronic fatigue syndrome, self-diagnosis based
on IOM criteria), and/or
- POTS (Postural Orthostatic Tachycardia Syndrome).
- Is interested in tools to manage ME/CFS, POTS, and/or Long COVID symptoms.
- Owns a wearable device they are willing to use for this study or does not own a
device and agrees to utilize a study-provided one.
- Agrees to wear the device throughout the study period, share the data with the
study, and sync data at least weekly.
- Has access to a smartphone or tablet to enable syncing wearable data and viewing
device feedback.
- Agrees to disclose involvement in other ME/CFS, POTS, and/or Long COVID
interventions such as medical treatment, self-management, and other interventional
studies.
- Agrees to complete at least 75% of the study surveys.
Exclusion Criteria:
- As long as they meet inclusion there is no exclusion
Scripps Research
La Jolla, California, United States
Investigator: Andrea Goosen
Andrea Goosen
0000000000
agoosen@scripps.edu
Romina Foster-Bonds
rfoster@scripps.edu
Not Provided