NCT03207802

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

September 10, 2019

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

June 30, 2017

Last Update Submit

September 9, 2019

Conditions

CHF

Outcome Measures

Primary Outcomes (1)

  • Data correlation

    Correlation between data collection and potential heart failure event

    2-6 months

Study Arms (1)

Cohort 3

This cohort is living at home with a chronic condition.

Device: Discontinuation of using device

Interventions

Discontinuation of using deviceDEVICE

Subject will be instructed to discontinuation of use of device

Cohort 3

Eligibility Criteria

Age22 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving home health care with one or more chronic diseases including CHF

You may qualify if:

  • Chronic Disease including CHF
  • Currently receiving home health care
  • Recent discharge for a CHF event

You may not qualify if:

  • Skin reaction to electrodes
  • Inability to take measurements due to low BMI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elite Home Health

Texarkana, Arkansas, 71854, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 5, 2017

Study Start

June 21, 2017

Primary Completion

December 17, 2017

Study Completion

December 20, 2017

Last Updated

September 10, 2019

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)