The Long COVID-19 Wearable Device Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Scripps Research
RECRUITING
La Jolla
Contact Information
Primary
Andrea Goosen
agoosen@scripps.edu
0000000000
Backup
Romina Foster-Bonds
rfoster@scripps.edu
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 100500
Treatments
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.
Sponsors
Leads: Scripps Translational Science Institute

This content was sourced from clinicaltrials.gov

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