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