Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSaint Luke's Health System

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • VitalCare Platform

    Device

    All 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

30 Participants
are divided into 1 treatment group
Group A: InterventionalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
6 month

Secondary outcomes

1

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.

Time frame
6 months
2

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

Time frame
6 month

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: