Covid19
Conditions
Keywords
wearable, at-home
Brief summary
The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.
Interventions
DEVICECurrent Health
wearable device and tablet used to collect health measures at home
Sponsors
Biomedical Advanced Research and Development Authority
Current Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Living in the United States (contiguous states) * Aged 21 years or older * Able to provide documentation of +Polymerase Chain Reaction (PCR) or +antigen test for COVID-19 within the past 48 hours * Self-reports that comfortable and willing to wear the wearable device and interact with a tablet-based interface daily * Able to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow up.
Exclusion criteria
* Under the age of 21 * Received a positive test result more than 48 hours prior to contacting study staff or has a pending test for COVID-19 * Cannot confirm a PCR or antigen positive test for COVID-19 * Is unable to read English * Is unwilling to wear the device 24 hours/day except for showering/bathing or interact with a tablet-based interface for daily questionnaire * Is unwilling or unable to provide baseline data required for entry into the study * Is unable to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow-up * Heavy tattooing on both upper arms * Known atrial fibrillation (permanent or paroxysmal) * Has taken/is taking part in a COVID-19 vaccine or treatment trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Compliance | up to 30 days | a percentage of the number of 15 minute windows with vital sign data compared to the number of 15 minute windows with the potential to have vital sign data. The 15 minute windows with the potential to have vital sign data was calculated based on the number of days the participant was enrolled in the study. There were multiple study endpoints; the number of days varied between 14-30 days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COVID19+ Current Health: wearable device and tablet used to collect health measures at home | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | COVID19+ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 35.6 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Participant Compliance
a percentage of the number of 15 minute windows with vital sign data compared to the number of 15 minute windows with the potential to have vital sign data. The 15 minute windows with the potential to have vital sign data was calculated based on the number of days the participant was enrolled in the study. There were multiple study endpoints; the number of days varied between 14-30 days.
Time frame: up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID19+ | Participant Compliance | 74 percentage of time |