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 — DEVICEThe 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 wearablesFollowing 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 wearablesFollowing 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 wearablesFollowing 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 wearablesFollowing 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
- Andrea Goosen0000000000
- Romina Foster-Bonds
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Scripps Research | La Jolla | California | 92037 | Andrea Goosen |
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