Behavioral Changes, Cardiovascular Complication, Covid19
Conditions
Keywords
Digital Health
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.
Interventions
None listed
Sponsors
Tulane University
Biostrap
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major cardiovascular events | 12 Months | Including arrhythmia occurrence or recurrence, congestive heart failure, myocardial infarction, cardiomyopathy and ischemic stroke. |
| Incidence of atrial arrhythmia | 12 Months | Including atrial fibrillation, atrial flutter, atrial tachycardia |
| 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 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. |
| 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 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNassir Marrouche, MD
Tulane University School of Medicine
Outcome results
None listed