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Wearable Device for Long COVID

N/A

Recruiting

Research Sponsored by Scripps Translational Science Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is at least 18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess if wearable devices and education can help people with Long COVID manage their symptoms.

Who is the study for?

This trial is for adults over 18 with a self or physician diagnosis of Long COVID, ME/CFS (chronic fatigue syndrome), or POTS (rapid heartbeat when standing). Participants must own or be willing to use a wearable device for symptom management and agree to share data regularly.

What is being tested?

The study aims to understand Long COVID better by using wearable devices. Participants will receive educational materials and use their own or provided wearables to track symptoms and see if this helps manage post-exertional malaise.

What are the potential side effects?

Since the intervention involves non-invasive monitoring with a wearable device, significant side effects are not anticipated. However, some individuals may experience discomfort from wearing the device continuously.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

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.

Secondary study objectives

Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity.

Other study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Treatment: study provided wearablesExperimental Treatment1 Intervention

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.

Group II: Treatment: self provided wearablesExperimental Treatment1 Intervention

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.

Group III: Control: study provided wearablesExperimental Treatment1 Intervention

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.

Group IV: Control: self provided wearablesExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Wearable device

2018

N/A

~130

0 / 1Eligibility criteria met