The Long COVID-19 Wearable Device Study

Scripps Translational Science Institute

Status: Enrolling

Conditions: Long Covid19; Myalgic Encephalomyelitis; Long COVID; Postural Orthostatic Tachycardia Syndrome; Chronic Fatigue Syndrome; Dysautonomia

Treatments: Device: Wearable device

Study type: Interventional

Funder types: Other

Identifiers

NCT05741112

LCWS 001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100,500 participants in 4 patient groups

Control: study provided wearables

Other group

Description:

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.

Treatment:

Device: Wearable device

Treatment: study provided wearables

Other group

Description:

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.

Treatment:

Device: Wearable device

Control: self provided wearables

Other group

Description:

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.

Treatment:

Device: Wearable device

Treatment: self provided wearables

Other group

Description:

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.

Treatment:

Device: Wearable device