The Long COVID-19 Wearable Device Study
1 other identifier
interventional
100,500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedStudy Start
First participant enrolled
November 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMay 11, 2025
May 1, 2025
2 years
February 17, 2023
May 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
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.
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.
12 months
Study Arms (4)
Control: study provided wearables
OTHERFollowing 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: study provided wearables
OTHERFollowing 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.
Control: self provided wearables
OTHERFollowing 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: self provided wearables
OTHERFollowing 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
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scripps Research
La Jolla, California, 92037, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
February 17, 2023
First Posted
February 23, 2023
Study Start
November 16, 2023
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
May 11, 2025
Record last verified: 2025-05