The Long COVID-19 Wearable Device Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorScripps Translational Science Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Is at least 18 years old.

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).

Disqualifiers

As long as they meet inclusion there is no exclusion

Trial design

Design model

Single group

Treatments tested in this trial

  • Wearable device

    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 groups

100,500 Participants
are divided into 4 treatment groups
Group A: Control: study provided wearablesOther 1 intervention
Group B: Treatment: study provided wearablesOther 1 intervention
Group C: Control: self provided wearablesOther 1 intervention
Group D: Treatment: self provided wearablesOther 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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 outcomes

1

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

Other outcomes

1

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

Sponsors and contacts

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