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Completed

NCT Number: NCT04605965

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

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.

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Key information

Conditions

Covid19 Behavioral Changes COVID-19 Cardiovascular Complication Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tulane University, New Orleans, Louisiana, United States

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About this study

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 200 participants who were diagnosed with COVID-19.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of major cardiovascular events

    Time frame: 12 Months

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

  2. Incidence of atrial arrhythmia

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • Biostrap

Registry information

Official study title

Wearable Health Data to Investigate Long-term Cardiovascular and Behavioral Health Outcomes in COVID-19 Patients After Discharge: The WEAICOR Study

Acronym: WEAICOR

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2020
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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