Feasibility Study of VitalCare Remote Monitoring for Heart Failure

This study is testing a remote monitoring system called VitalCare for people with congestive heart failure (CHF). The VitalCare platform includes a tablet, a device to record heart and lung sounds, a blood pressure cuff, a pulse oximeter (measures oxygen in blood), and a digital scale. The goal is to see how well people use the VitalCare system and if it helps manage their heart failure. You might be able to join if you have a diagnosis of heart failure, have had a hospital stay for heart failure in the last year, and are comfortable using a smartphone or tablet. The study will look at how often participants use the monitoring system over 6 months. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is a pilot study examining the feasibility of using the VitalCare platform.
What's involved
You would use the VitalCare platform, which includes a tablet and various medical devices, for 6 months. Your data would be reviewed monthly by a clinician.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, compliance with monitoring, is measured at 6 months.

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NCT05900362

Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

UNKNOWN
NAAges 18–80InterventionalTreatment
Saint Luke's Health System
~30 participants
Updated 2024-06-06 on ClinicalTrials.gov
What's tested:VitalCare Platform

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compliance with monitoring protocol
Measured over 6 month
Congestive Heart Failure
4 sites across 2 states
Kansas2
Missouri2

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

A clinical diagnosis of heart failure
New York Heart Association Class II or III congestive HF symptoms
Admission to hospital within 12 months for symptomatic heart failure.
Own a smartphone or tablet or comfortable with using one
English as primary language
Able to provide informed consent

Exclusion

Left Ventricular Ejection Fraction \< 35%
Implanted cardiac device (permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), chronic resynchronization therapy (CRT), implantable loop recorder (ILR))
CardioMEMS
Left ventricular assist device (LVAD)
NYHA Class I or IV congestive HF symptoms
Listed for cardiac transplant
Pregnant at time enrollment
End-stage renal disease
  • Compliance with monitoring protocol6 month

    Actual rate of completed patient data transmissions is greater than or equal to 60% of the expected rate of patient data transmissions (BP, HR, Weight, EKG)