About this trial
Previous research has investigated the use of remote patient monitoring in various clinical contexts, however there has not been a clinical trial examining use of the VitalCare platform for ambulatory management of heart failure. This trial will serve as a pilot study examining the feasibility of use of the VitalCare platform for ambulatory heart failure management and examine the effect of remote patient monitoring on patient engagement. To the investigators' knowledge, this will be the first study examining the effect of remote patient monitoring with the VitalCare platform on heart failure clinical outcomes, such as hospitalization for heart failure exacerbations and emergency room visits for heart failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
VitalCare Platform
DeviceAll participants will receive an VitalCare platform with tablet, Eko Duo with capability to record heart/lung sounds, blood pressure cuff, pulse oximetry and digital scale
Treatment groups
Trial outcomes
Primary outcomes
Compliance with monitoring protocol
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)
Secondary outcomes
Patient engagement as measured by Patient Activation Measure
Patient engagement as measured by the Patient Activation Measure will increase by 1 or more points from baseline to 6 months. The PAM score ranges from 1 to 100 corresponding to 1 of 4 levels of patient engagement. Higher numbers correlate with greater patient engagement.
Heart failure hospitalizations, emergency room visits for Heart Failure as compared to prior to trial enrollment
Patients who undergo remote patient monitoring via the VitalCare platform will have a lower rate of hospitalization for heart failure and lower rate of emergency room presentation for heart failure symptoms as compared to previous rate of heart failure hospitalization and emergency room presentations for heart failure symptoms for the 6 months prior to trial enrollment
Sponsors and contacts
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