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

• ClinicalTrials.gov Identifier: NCT04605965
• Recruitment Status: Active, not recruiting
• First Posted: October 28, 2020
• Last Update Posted: November 29, 2021
• Sponsor: Tulane University
• Collaborator: Biostrap
• Information provided by (Responsible Party): Tulane University

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
Covid19; Cardiovascular Complication; Behavioral Changes

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
• Target Follow-Up Duration: 24 Months
• 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: June 9, 2020
• Estimated Primary Completion Date: November 2023
• Estimated Study Completion Date: November 2023

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patients with a positive COVID-19 diagnosis.

Criteria

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

United States, Louisiana

Tulane University, TRIAD Center

New Orleans, Louisiana, United States, 70119

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

More Information

• Responsible Party: Tulane University
• ClinicalTrials.gov Identifier: NCT04605965
• Other Study ID Numbers: 2020-678
• First Posted: October 28, 2020
• Last Update Posted: November 29, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: De-identified data may be used for secondary analyses/research on COVID19 complications

• 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; Problem Behavior; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavioral Symptoms