Clinical Trials Logo
  1. Home
  2. CHF
  3. NCT03207802
  4. Details
NCT03207802 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT03463148 - Validation of a Sensor for Non-Invasive Measurements
Completed NCT03339310 - Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System N/A
Completed NCT00288587 - Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF) Phase 4
Recruiting NCT05423652 - Aiding COPD and CHF Ultrasound-guided Management Through ENhanced Point Of Care UltraSound N/A
Recruiting NCT05865197 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF
Recruiting NCT02020811 - Safety and Efficacy of Immages System in Patients Recieving IV Therapy N/A
Withdrawn NCT01809730 - Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients N/A
Completed NCT01316432 - PK/PD Study of Subcutaneous Cenderitide Infusion in CHF Patients Phase 1
Completed NCT02632552 - A Technology Assisted Care Transition Intervention for Veterans With CHF or COPD N/A
Terminated NCT04154579 - Arts & Health Education to Improve Health, Resilience, and Well-Being N/A
Terminated NCT03102437 - Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System N/A
Completed NCT03808948 - FAST PV and mGFR™ Technology in Congestive Heart Failure N/A
Recruiting NCT04591964 - Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application Early Phase 1
Completed NCT05843201 - AquaPass Device in Treatment of CHF Patients N/A
Active, not recruiting NCT04090671 - Evaluation of the Multidimensional Dyspnea Profile (MDP) N/A
Completed NCT03905252 - Biomarkers for Human Heart Failure
Completed NCT04261452 - Heart Failure Worsens Muscle Strength in COPD N/A
Not yet recruiting NCT02873000 - Incentive Spirometry in Non-critically Ill Hospitalized Patients With Acute Respiratory Failure N/A