Clinical trial NCT05741112: The Long COVID-19 Wearable Device Study
Official title: The Long COVID-19 Wearable Device Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long COVID
Postural Orthostatic Tachycardia Syndrome
Dysautonomia
Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Long Covid19
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 100500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All participants will have a diagnosis of Long COVID-19, Chronic Fatigue Syndrome or Postural Orthostatic Tachycardia Syndrome.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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 on IOM 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 device and 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 viewing device feedback.
* Agrees to disclose involvement in other ME/CFS, POTS, and/or Long COVID interventions such as medical treatment, self-management, and other interventional studies.
* Agrees to complete at least 75% of the study surveys.

Exclusion Criteria:

* As long as they meet inclusion there is no exclusion

Primary outcomes:
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.
timeFrame: 3 months
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity.
timeFrame: 12 months
Other outcomes:
measure: 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.
timeFrame: 12 months
Locations:
city: La Jolla
country: United States
facility: Scripps Research
state: California
Study officials:
References: