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recruitment and enrollment challenges due to fast-changing landscape of pandemic
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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID19+ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Current Health | Device | wearable device and tablet used to collect health measures at home |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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community sample
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| Name | Affiliation | Role |
|---|---|---|
| Adam Wolfberg, MD | Current Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Current Health | New York | New York | 10017 | United States |
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| Label | URL |
|---|---|
| study information and eligibility for enrollment | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID19+ | Current Health: wearable device and tablet used to collect health measures at home |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COVID19+ | Current Health: wearable device and tablet used to collect health measures at home |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | percentage of time | up to 30 days |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COVID19+ | Current Health: wearable device and tablet used to collect health measures at home |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Lead | Current Health | 617-208-4239 | study.team@currenthealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 11, 2021 | Aug 5, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |