The Long COVID-19 Wearable Device Study

Sponsor

Scripps Translational Science Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05741112

Collaborator

(none)

100,500

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Long COVID Postural Orthostatic Tachycardia Syndrome Dysautonomia Myalgic Encephalomyelitis Chronic Fatigue Syndrome Long Covid19	Device: Wearable device	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100500 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

All participants will have a diagnosis of Long COVID-19, Chronic Fatigue Syndrome or Postural Orthostatic Tachycardia Syndrome.All participants will have a diagnosis of Long COVID-19, Chronic Fatigue Syndrome or Postural Orthostatic Tachycardia Syndrome.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Long COVID-19 Wearable Device Study

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Control: study provided wearables 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 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. Other Names: Educational materials
Other: Treatment: study provided wearables 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 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. Other Names: Educational materials
Other: Control: self provided wearables 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 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. Other Names: Educational materials
Other: Treatment: self provided wearables 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 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. Other Names: Educational materials

Outcome Measures

Primary Outcome Measures

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. [3 months]
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.
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. [12 months]
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.

Secondary Outcome Measures

Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity. [12 months]
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.

Other Outcome Measures

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. [12 months]
Cross-referencing heart rate patterns with participant-provided symptoms and diagnoses to identify correlations; identify underlying signals in surveys and/or wearable data that may help differentiate those who will recover within six months from those who will not recover for years; identify correlates with which individuals experience worsening symptoms over time, such as whether consistent reduced heart rate variability affects long-term symptoms as it does short-term symptoms. The self-provided wearable cohort can share data from the complete history of their wearable device (and in some cases the history from their ownership of a device of the same brand), therefore the investigators can also conduct within-subject analysis for those that were using a wearable device prior to their COVID-19 infection.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.