The Long COVID-19 Wearable Device Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05741112
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Scripps Translational Science Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Long COVID, Postural Orthostatic Tachycardia Syndrome, Dysautonomia, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Long Covid19

Additional Details

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.

Arms & Interventions

Arms

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Scripps Research, La Jolla, California

Status

Recruiting

Address

Scripps Research

La Jolla, California, 92037

Site Contact

Andrea Goosen

[email protected]

0000000000

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