An interventional study of Wearable device in Long COVID, Postural Orthostatic Tachycardia Syndrome and Dysautonomia, sponsored by Scripps Translational Science Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Scripps Translational Science Institute · Not applicable, Interventional, and Basic science
To further characterize Long COVID-19 by collecting data from individuals who already own wearable devices or are provided with a wearable device along with basic and enhanced educational materials to determine if both can improve Long COVID-19 symptom management and 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.
604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.
This study's planned enrollment of 100,500 is above the median of 60 across 416 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Scripps Translational Science Institute is the lead sponsor of 53 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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.
Device: Wearable device
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.
Device: Wearable device
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.
Device: Wearable device
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.
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.
Also known as: Educational materials
Primary Objective 1:Assess the effect of study-provided devices and enhanced educational materials to manage Long COVID-19 symptom severity, compared to general educational materials alone using data from participants survey responses.
Will measure relapse symptom frequency, symptom severity, pain, quality of life and overall health through the analysis and measurement of change in the weekly survey responses.
Time frame: 3 months
Primary Objective 2: Collate a unique longitudinal dataset combining patients' demographics, symptoms, symptom severity, quality of life, and sensor data including sleep, activity, heart rate, heart rate variability, and Body Battery.
Will measure relapse symptom frequency, symptom severity, pain, quality of life and overall health through the analysis and measurement of change from the baseline survey to the quarterly survey.
Time frame: 12 months
Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity.
Conduct within-subject comparisons on the primary and secondary endpoints listed above but such that the investigators are assessing the change between the baseline measurement at month zero and that of the quarterly survey nine months after the distribution of the device and/or enhanced education materials.
Time frame: 12 months
Exploratory Objective: Assess whether individuals who enroll in the study with their own wrist-worn wearable device and receive educational materials see a decrease in symptom severity and whether this differs by device brand and/or feature.
Cross-referencing heart rate patterns with participant-provided symptoms and diagnoses to identify correlations; identify underlying signals in surveys and/or wearable data that may help differentiate those who will recover within six months from those who will not recover for years; identify correlates with which individuals experience worsening symptoms over time, such as whether consistent reduced heart rate variability affects long-term symptoms as it does short-term symptoms. The self-provided wearable cohort can share data from the complete history of their wearable device (and in some cases the history from their ownership of a device of the same brand), therefore the investigators can also conduct within-subject analysis for those that were using a wearable device prior to their COVID-19 infection.
Time frame: 12 months
Plan to share: Undecided — The investigators may share the coded study data with researchers outside of Scripps Research. Before doing so, they will ensure that nothing in the data can identify the participant directly.
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Post-Acute COVID-19 Syndrome →
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