Necklace-Shaped Sensor for Non-Invasive Measurement of Vital Signs, Thoracic Impedance, ECG, Skin Temperature and Motion
| Registry | NCT03207802 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 36 (Actual) |
| Sponsor | Baxter Healthcare Corporation (Industry) |
| Conditions | CHF |
| Interventions | Discontinuation of using device (Device) |
| Dates | start 2017-06-21, primary completion 2017-12-17, completion 2017-12-20, first posted 2017-07-05, last updated 2019-09-10 |
| Locations | 1 site in United States |
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Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health.
Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health. Data from the CoVa Monitoring System will be compared against electronic health records to determine if the data captured will provide insight into a patient's overall health. Additionally, user compliance will be monitored
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort 3 | Device: Discontinuation of using device | This cohort is living at home with a chronic condition. |
Sex: All, ages: 22 Years to 99 Years
Inclusion Criteria: * Chronic Disease including CHF * Currently receiving home health care * Recent discharge for a CHF event Exclusion Criteria: * Skin reaction to electrodes * Inability to take measurements due to low BMI
| Facility | City | Country | Status |
|---|---|---|---|
| Elite Home Health | Texarkana, Arkansas | United States |