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

Active, not recruiting

• Conditions: Covid19; Behavioral Changes; Cardiovascular Complication

• Registration Number: NCT04605965
• Lead Sponsor: Tulane University

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.

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 200 participants who were diagnosed with COVID-19.

Study Timeline

• Study Start: 2020-06-09
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-10-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of major cardiovascular events	12 Months	Including arrhythmia occurrence or recurrence, congestive heart failure, myocardial infarction, cardiomyopathy and ischemic stroke.
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
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
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
Incidence of atrial arrhythmia	12 Months	Including atrial fibrillation, atrial flutter, atrial tachycardia
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
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
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.

Trial Locations

Locations (2)

Tulane University, TRIAD Center; 🇺🇸 New Orleans, Louisiana, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States