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Protocol Details

A Prospective Natural History Study of COVID-19 Using Digital Wearables

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000315-MD

Sponsoring Institute

National Institute on Minority Health and Health Disparities (NIMHD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Children

Special Instructions

Currently Not Provided

Keywords

Pneumonia;
COVID-19 Sequelae;
Physiological data;
Clinical course;
Mobile technology

Recruitment Keyword(s)

None

Condition(s)

COVID-19 Virus Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Minority and Health Disparity

Background:

People with COVID-19 have varying degrees of illness. It can range from no or mild symptoms to critical illness and death. Some people with COVID-19 have long-term effects regardless of the severity of their disease initially. Researchers want to learn more to see if they can better predict where a person may fall on the illness spectrum.

Objective:

To follow and record symptoms of COVID-19 to see how it progresses in people and why some people stay sick longer than others.

Eligibility:

People ages 18-65 who received a COVID-19 positive test result in the 72 hours before their enrollment in the study.

Design:

Participants will complete a 30-minute baseline survey. They will answer questions about themselves and their health.

Participants will get a digital wristband and temperature sensor in the mail. They will get instructions on how to set up and wear the devices. They will download a mobile application on their phone. The app will collect data from the devices.

Participants will wear the wristband and sensor every day for the first month. Then they will wear the devices for a total of 40 days over the next 5 months. On the days they wear the devices, they will answer a 2-question health survey via the app.

Participants will answer a 20-minute online survey about their health every 30 days.

If participants are hospitalized, a family member or close friend will be asked to complete a brief 7-minute online survey about their hospital stay and treatment.

Participants will be sent alerts and reminders throughout the study. Participation will last for 6 months.

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Eligibility

INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all the following criteria:

-Stated willingness to comply with all study procedures and availability for the duration of the study.

-Male or female, aged 18 to 65. The pediatric population <18 years differs from adults >18 years in infection rates, symptom manifestation, and outcomes (e.g., multi- inflammatory syndrome). Although population 12 and older is now eligible to receive the vaccine, population over 65 was the first eligible age group to receive the vaccine in the US. Furthermore, protections are in place to reduce transmission among the elderly in general and in nursing homes in particular.

-Documentation of a SARS-Cov-19 positive test (PCR or antigen/rapid test) <=5 days before enrollment. Recruitment materials list patients must be within 3 days of a positive test, which gives the research team 2 days to enroll patients in the study. Self-collection

kits and home tests for COVID-19 are not permitted because of the potential for inappropriate sampling and sample contamination.

-Owns or has access to supported device (i.e., smartphone or a tablet) that compliant with the specifications listed below and with an existing cellular data plan:

a. Android phones and tables with an operating system of 6.0 or newer (6.0, Bluetooth 4.2 or Bluetooth 5.0 support, and which implement Bluetooth Low Energy (BLE) standard)

b. iPhone SE (1st, 2nd generation), 6s/6s plus, 7/7 plus, 8/8 plus, X, XS, XR, 11, 11 Pro, 11 Pro Max, 12, 12 Mini, 12 Pro, 12 Pro Max

c. iPad mini 4; iPad mini (5th generation), iPad (5th, 6th, 7th, 8th generation); iPad Air 2; iPad Air (3rd, 4th generation); 9.7- inch iPad Pro; 10.5-inch iPad Pro; 11-inch iPad pro (1st, 2nd, and 3rd generation); 12.9-inch iPad pro (1st, 2nd, 3rd, 4th, 5th generation)

d. Devices released in 2021 and afterward that are compatible with the Biostrap app.

-Speaks English. Non-English speakers will be unable to use the Biostrap mobile app. Although efforts are currently underway to provide the app in Spanish, the current app is only available in English.

-Agreement to adhere to lifestyle considerations throughout the study duration (i.e., wear a digital wristband and temperature patch).

-Ability of subject to understand and willingness to consent to the participate.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

-Enrollment in clinical trials on experimental COVID-19 therapeutics at baseline. Patients will be instructed to alert the NIMHD research team if a patient participates in a clinical trial after enrollment in this study.

-Upon recruitment, requires invasive or non-invasive assisted ventilation.

-Inability to consent.

-Unwillingness to comply with study procedures (i.e., wearing a wristband and temperature patch, downloading a mobile application, providing proof of positive COVID-19 test, providing data required for the study such as medical history data and contact information for two close kin).

-Participants residing outside US mainland.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Sherine M. El-Toukhy, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)



Sherine M. El-Toukhy, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
National Institutes of Health
Building 3
Room 5E11B
3 Center Drive
Bethesda, Maryland 20892
(301) 594-4743
sherine.el-toukhy@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04927442

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