search
Back to results

The Long COVID-19 Wearable Device Study

Primary Purpose

Long COVID, Postural Orthostatic Tachycardia Syndrome, Dysautonomia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wearable device
Sponsored by
Scripps Translational Science Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Long COVID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. Exclusion Criteria: As long as they meet inclusion there is no exclusion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    Control: study provided wearables

    Treatment: study provided wearables

    Control: self provided wearables

    Treatment: self provided wearables

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    February 21, 2023
    Sponsor
    Scripps Translational Science Institute
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05741112
    Brief Title
    The Long COVID-19 Wearable Device Study
    Official Title
    The Long COVID-19 Wearable Device Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    May 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Scripps Translational Science Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Long COVID, Postural Orthostatic Tachycardia Syndrome, Dysautonomia, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Long Covid19

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    All participants will have a diagnosis of Long COVID-19, Chronic Fatigue Syndrome or Postural Orthostatic Tachycardia Syndrome.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control: study provided wearables
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Treatment: study provided wearables
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Control: self provided wearables
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Treatment: self provided wearables
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Wearable device
    Other Intervention Name(s)
    Educational materials
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    3 months
    Title
    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.
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity.
    Description
    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.
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    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.
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrea Goosen
    Phone
    17865143625
    Email
    agoosen@scripps.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Romina Foster-Bonds
    Email
    rfoster@scripps.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The investigators may share the coded study data with researchers outside of Scripps Research. Before doing so, they will ensure that nothing in the data can identify the participant directly.

    Learn more about this trial

    The Long COVID-19 Wearable Device Study

    We'll reach out to this number within 24 hrs