Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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The next step in determining the role of remote patient monitoring in the management of patients with heart failure is to better understand which patients are most likely to benefit from a more intensive outpatient management or simply conservative management. The subject population is patients with mild HFrEF or HFpEF who are prone to readmission. This patient population does not have implanted devices to supply objective data to evaluate patient's volume status and therefore can be challenging to manage on an outpatient basis. By providing regular data on weight, blood pressure, pulse oximetry, electrocardiogram and heart/lung sounds that is reviewed on a monthly basis, this may allow a clinician greater insight into their patient's clinical status and allow for a more accurate and timely intervention to prevent clinical deterioration. Furthermore, this should enhance patient engagement with their own health as well as with their healthcare provider. This study would significantly add to the current knowledge of management of heart failure in an ambulatory patient population without implanted devices.

Official Title
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Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: VitalCare Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>All patients receive the VitalCare platform with a tablet computer, an Eko Duo device, a weight scale, a blood pressure cuff, a pulse oximeter | Device: VitalCare Platform<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| 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 | 6 month |