The Long COVID-19 Wearable Device Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Fatigue Syndrome; Postural Orthostatic Tachycardia Syndrome; Dysautonomia; Long COVID; Long Covid19; Myalgic Encephalomyelitis
• Intervention / Treatment: Device: Wearable device

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Romina Foster-Bonds; Email: rfoster@scripps.edu
• Study Contact Backup: Name: Andrea Goosen; Phone Number: 0000000000; Email: agoosen@scripps.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Scripps Research
      • Contact: Andrea Goosen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Educational materials
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.	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.; Other Names: Educational materials
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.	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.; Other Names: Educational materials
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.	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.; Other Names: Educational materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Scripps Translational Science Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Neuroinflammatory Diseases; Post-Infectious Disorders; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Muscular Diseases; Pathologic Processes; Heart Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease; Arrhythmias, Cardiac; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Orthostatic Intolerance; Central Nervous System Infections; COVID-19; Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic; Syndrome; Tachycardia; Autonomic Nervous System Diseases; Primary Dysautonomias; Encephalomyelitis; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: LCWS 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators may share the coded study data with researchers outside of Scripps Research. Before doing so, they will ensure that nothing in the data can identify the participant directly.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No