Remotely Monitoring Patients With Chronic Conditions in Their Home

CHF Clinical Trial

Official title:

Necklace-Shaped Sensor for Non-Invasive Measurement of Vital Signs, Thoracic Impedance, ECG, Skin Temperature and Motion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207802
• Other study ID #: PERM-IRB-001-OCS
• Status: Completed
• Start date: June 21, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: January 2018
• Source: toSense, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 20, 2017
• Est. primary completion date: December 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• CHF

Intervention

Device:
• Discontinuation of using device
Subject will be instructed to discontinuation of use of device

Locations

Country	Name	City	State
United States	Elite Home Health	Texarkana	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
toSense, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data correlation	Correlation between data collection and potential heart failure event	2-6 months