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

Covid19 Clinical Trial

— WEAICOR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04605965
• Other study ID #: 2020-678
• Status: Active, not recruiting
• Start date: June 9, 2020
• Est. completion date: January 2024

Study information

• Verified date: December 2023
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavioral Changes
• Cardiovascular Complication
• COVID-19
• Covid19

Locations

Country	Name	City	State
United States	Tulane University	New Orleans	Louisiana
United States	Tulane University, TRIAD Center	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University	Biostrap

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major cardiovascular events	Including arrhythmia occurrence or recurrence, congestive heart failure, myocardial infarction, cardiomyopathy and ischemic stroke.	12 Months
Primary	Incidence of atrial arrhythmia	Including atrial fibrillation, atrial flutter, atrial tachycardia	12 Months
Primary	Mental health effect of COVID-19 measured by incidence of Generalized Anxiety Disorder (GAD) using Generalized Anxiety Disorder 7-item (GAD-7) Scale	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	12 Months
Primary	Mental health effect of COVID-19 measured by incidence of depression using Beck Depression Fast Screen Scale	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	12 Months
Primary	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	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.	12 Months
Primary	Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of alcohol survey	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	12 Months
Primary	Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of drugs survey	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	12 Months
Primary	Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of nicotine products survey	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	12 Months