The Long COVID-19 Wearable Device Study

Study Overview
=================
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.

Official Title
-----------------
The Long COVID-19 Wearable Device Study

Conditions
-----------------
Long COVID, Postural Orthostatic Tachycardia Syndrome, Dysautonomia, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Long Covid19

Intervention / Treatment
-----------------
* Device: Wearable device


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will have a diagnosis of Long COVID-19, Chronic Fatigue Syndrome or Postural Orthostatic Tachycardia Syndrome.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control: study provided wearables<br>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. | Device: Wearable device<br>* 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.<br>* Other names: Educational materials;|
| Other: Treatment: study provided wearables<br>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. | Device: Wearable device<br>* 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.<br>* Other names: Educational materials;|
| Other: Control: self provided wearables<br>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. | Device: Wearable device<br>* 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.<br>* Other names: Educational materials;|
| Other: Treatment: self provided wearables<br>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. | Device: Wearable device<br>* 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.<br>* Other names: Educational materials;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Will measure relapse symptom frequency, symptom severity, pain, quality of life and overall health through the analysis and measurement of change in the weekly survey responses. | 3 months | 
| 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. | Will measure relapse symptom frequency, symptom severity, pain, quality of life and overall health through the analysis and measurement of change from the baseline survey to the quarterly survey. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity. | Conduct within-subject comparisons on the primary and secondary endpoints listed above but such that the investigators are assessing the change between the baseline measurement at month zero and that of the quarterly survey nine months after the distribution of the device and/or enhanced education materials. | 12 months |