The Long COVID-19 Wearable Device Study

Last updated: April 15, 2024
Sponsor: Scripps Translational Science Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Neurologic Disorders

Fibromyalgia

Treatment

Wearable device

Clinical Study ID

NCT05741112
LCWS 001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 onIOM 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 deviceand 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 viewingdevice feedback.
  • Agrees to disclose involvement in other ME/CFS, POTS, and/or Long COVID interventionssuch as medical treatment, self-management, and other interventional studies.
  • Agrees to complete at least 75% of the study surveys.

Exclusion

Exclusion Criteria:

  • As long as they meet inclusion there is no exclusion

Study Design

Total Participants: 100500
Treatment Group(s): 1
Primary Treatment: Wearable device
Phase:
Study Start date:
November 16, 2023
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • Scripps Research

    La Jolla, California 92037
    United States

    Active - Recruiting

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