Determine Return on Investment in Heart Failure Remote Monitoring Program

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.