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WEAICOR: Wearables to Investigate the Long Term Cardiovascular and Behavioral Impacts of COVID-19

Sponsor
Tulane University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04605965
Collaborator
Biostrap (Other)
200
Enrollment
2
Locations
52.8
Anticipated Duration (Months)
100
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observational COVID-19 study that uses wearable health monitoring technology to follow COVID-19 positive individuals to monitor persistent symptoms and any potential long-term complications or cardiovascular and behavioral impacts from the disease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Participants will wear a Biostrap wristband device that captures high-fidelity, raw photoplethysmography (PPG) waveforms and collects important indicators of heart and mental health, including heart rate, heart rate variability, pulse points, oxygen saturation and sleep patterns. Biometric data will be collected and participants will be alerted if any measurements are outside their normal range.

    Researchers are recruiting 100 participants who were diagnosed with COVID-19.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Wearable Health Data to Investigate Long-term Cardiovascular and Behavioral Health Outcomes in COVID-19 Patients After Discharge: The WEAICOR Study
    Actual Study Start Date :
    Jun 9, 2020
    Anticipated Primary Completion Date :
    Nov 1, 2024
    Anticipated Study Completion Date :
    Nov 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of major cardiovascular events [12 Months]

      Including arrhythmia occurrence or recurrence, congestive heart failure, myocardial infarction, cardiomyopathy and ischemic stroke.

    2. Incidence of atrial arrhythmia [12 Months]

      Including atrial fibrillation, atrial flutter, atrial tachycardia

    3. Mental health effect of COVID-19 measured by incidence of Generalized Anxiety Disorder (GAD) using Generalized Anxiety Disorder 7-item (GAD-7) Scale [12 Months]

      Generalized Anxiety Disorder 7-item (GAD-7) Scale includes 7 questions to be answered by the patient, each answer is scored from 0 to 3, and the scale range is from 0 to 21, with a higher number representing more severe GAD level

    4. Mental health effect of COVID-19 measured by incidence of depression using Beck Depression Fast Screen Scale [12 Months]

      Beck Depression Fast Screen Scale includes 21 questions to be answered by the patient scored from 0 to 3, and the scale range is from 0 to above 40, with a higher number representing more severe depression level

    5. Mental health effect of COVID-19 measured by incidence of Post Traumatic Stress Syndrome (PTSD) using the Post Traumatic Stress Disorder Checklist- Standard Form (PCL-S) scale [12 Months]

      Post Traumatic Stress Disorder Checklist- Standard Form (PCL-S) Scale includes 20 questions to be answered by the patient scored from 1 to 5. Total symptom severity score (ranging 0-80) can be obtained by summing the scores for each of the 20 items. Higher number represents more likely that the patient has PTSD.

    6. Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of alcohol survey [12 Months]

      Baseline use of alcohol survey includes ten questions to be answered by the patient scored from 0 to 4 with a higher number representing increased alcohol consumption

    7. Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of drugs survey [12 Months]

      Baseline use of drugs survey includes ten questions to be answered by the patient scored from 0 to 4 with a higher number representing increased drug use

    8. Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of nicotine products survey [12 Months]

      Baseline use of nicotine products survey includes 4 questions to be answered by the patient to find out which nicotine products the patient is using if any and how many cigarettes they're smoking per day

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Positive COVID-19 diagnosis

    • Ages 18 to 120

    • Access to WiFi

    Exclusion Criteria:

    • Negative COVID-19 diagnosis

    • Age younger than 18 and older than 120

    • Lack of access to WiFi

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tulane University, TRIAD Center New Orleans Louisiana United States 70119
    2 Tulane University New Orleans Louisiana United States 70119

    Sponsors and Collaborators

    • Tulane University
    • Biostrap

    Investigators

    • Principal Investigator: Nassir Marrouche, MD, Tulane University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tulane University
    ClinicalTrials.gov Identifier:
    NCT04605965
    Other Study ID Numbers:
    • 2020-678
    First Posted:
    Oct 28, 2020
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tulane University
    Digital Health
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jul 20, 2022