Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100500 participants
INTERVENTIONAL
2023-11-16
2025-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Control: study provided wearables
Following consent and the completion of the baseline assessments the control group will receive basic education on symptom management. At the 3 month timepoint they will be prompted to order their device and receive enhanced education that will provide information on how wearable devices can be used to monitor and manage symptoms.
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.
Treatment: study provided wearables
Following consent and the completion of the baseline assessments the treatment group will be prompted to order their device and receive basic education on symptom management along with the enhanced education on wearable devices.
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.
Control: self provided wearables
Following consent and the completion of the baseline assessments the control group will receive basic education on symptom management. At the 3 month timepoint they will be receive enhanced education that will provide information on how wearable devices can be used to monitor and manage symptoms.
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.
Treatment: self provided wearables
Following consent and the completion of the baseline assessments the treatment group will receive basic education on symptom management along with the enhanced education on wearable devices.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Scripps Translational Science Institute
OTHER
Responsible Party
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Julia Moore Vogel
Director
Locations
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Scripps Research
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Andrea Goosen
Role: primary
Other Identifiers
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LCWS 001
Identifier Type: -
Identifier Source: org_study_id
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