The Long COVID-19 Wearable Device Study

Part of paid clinical trials in La Jolla, California.

Sponsor
Scripps Translational Science Institute
Study ID
NCT05741112
Status
Recruiting

Conditions

  • Chronic Fatigue Syndrome
  • Dysautonomia
  • Long COVID
  • Long Covid19
  • Myalgic Encephalomyelitis
  • Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wearable device — 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.

Study Details

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.

Key Dates

Start date
Nov 16, 2023
Status verified
May 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
100,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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. [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps ResearchLa JollaCalifornia92037
Andrea Goosen

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