Clinical trial NCT04605965: WEAICOR: Wearables to Investigate the Long Term Cardiovascular and Behavioral Impacts of COVID-19
Official title: Wearable Health Data to Investigate Long-term Cardiovascular and Behavioral Health Outcomes in COVID-19 Patients After Discharge: The WEAICOR Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Cardiovascular Complication
Behavioral Changes
Keywords: Digital Health
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Biostrap
First posted: 2020-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a positive COVID-19 diagnosis.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of major cardiovascular events
timeFrame: 12 Months
measure: Incidence of atrial arrhythmia
timeFrame: 12 Months
measure: Mental health effect of COVID-19 measured by incidence of Generalized Anxiety Disorder (GAD) using Generalized Anxiety Disorder 7-item (GAD-7) Scale
timeFrame: 12 Months
measure: Mental health effect of COVID-19 measured by incidence of depression using Beck Depression Fast Screen Scale
timeFrame: 12 Months
measure: 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
timeFrame: 12 Months
measure: Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of alcohol survey
timeFrame: 12 Months
measure: Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of drugs survey
timeFrame: 12 Months
measure: Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of nicotine products survey
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University, TRIAD Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
affiliation: Tulane University School of Medicine
name: Nassir Marrouche, MD
role: PRINCIPAL_INVESTIGATOR
References: