Determine Return on Investment in Heart Failure Remote Monitoring Program

A Prospective Randomized Controlled Trial to Determine Return on Investment in a Tablet/Smartphone-based Heart Failure Remote Monitoring Program

The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).

The objective of this remote monitoring study is to evaluate return on investment and end-user clinical outcomes associated with the use of self-monitoring peripherals and tablet/smartphone-based Welch Allyn HealthInterlink technology without intervention (Control), HealthInterlink remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1), and HealthInterlink remote monitoring with nurse research assistant follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2 added to Intervention 1).

Inclusion Criteria:

• Absence of significant vision, hearing, or other communication deficits
• English speaking;
• Capable and willing to give informed consent;
• Participated in the in-patient heart failure class within the last three months. Acceptable candidate for elective, non-emergent, remote monitoring as determined by ordering physician;
• Living in a private home;
• Hospital admission for Heart Failure or decompensation in the previous 12 months
• New York Heart Association (NYHA) classes II-IV, as assigned by the nurse researcher, trained by a cardiologist
• Cardiac aetiology: ischaemic, idiopathic, hypertensive, or valvular
• Left ventricular ejection fraction <40% s an index of systolic dysfunction, combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.

or

• NYHA class II-III who had an ejection fraction >40% and evidence of diastolic left ventricular dysfunction.
• Optional subject with a diagnosis of diabetes (indicated by HbA1c >7).

Exclusion Criteria:

• Currently involved in other investigational clinical trials (unless permission is granted by other study PI);
• Females who are pregnant, planning to become pregnant within 3 months, or lactating;
• Requirement for emergent placement other than private home (subject's condition would be compromised if there is a delay in placement).
• Myocardial infarction, revascularization or Implantable Cardioverter Defibrillator (ICD) implantation in the previous 6 months angina or objective myocardial ischaemia requiring future revascularization implanted ventricular or atrial pacemaker (except dual chamber ICD pacemakers with good sinus activity);
• End-stage heart failure requiring regular inotropic drug infusions;
• Chronic renal failure requiring dialysis treatment and
• Unstable angina.