NCT04605965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2025

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

August 12, 2020

Last Update Submit

March 3, 2026

Conditions

Covid19Cardiovascular ComplicationBehavioral Changes

Keywords

Digital Health

Outcome Measures

Primary Outcomes (8)

  • Incidence of major cardiovascular events

    Including arrhythmia occurrence or recurrence, congestive heart failure, myocardial infarction, cardiomyopathy and ischemic stroke.

    12 Months

  • Incidence of atrial arrhythmia

    Including atrial fibrillation, atrial flutter, atrial tachycardia

    12 Months

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a positive COVID-19 diagnosis.

You may qualify if:

  • Positive COVID-19 diagnosis
  • Ages 18 to 120
  • Access to WiFi

You may not qualify if:

  • Negative COVID-19 diagnosis
  • Age younger than 18 and older than 120
  • Lack of access to WiFi

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tulane University, TRIAD Center

New Orleans, Louisiana, 70119, United States

Location

Tulane University

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nassir Marrouche, MD

    Tulane University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

October 28, 2020

Study Start

June 9, 2020

Primary Completion

June 8, 2025

Study Completion

June 8, 2025

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(2)