Trials / Recruiting
RecruitingNCT05741112
The Long COVID-19 Wearable Device Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100,500 (estimated)
- Sponsor
- Scripps Translational Science Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Long COVID
- Postural Orthostatic Tachycardia Syndrome
- Dysautonomia
- Myalgic Encephalomyelitis
- Chronic Fatigue Syndrome
- Long Covid19
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-11-16
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2023-02-23
- Last updated
- 2025-05-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05741112. Inclusion in this directory is not an endorsement.