Naples, Florida 34102


Purpose:

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).


Study summary:

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).


Criteria:

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.


NCT ID:

NCT02475577


Primary Contact:

Principal Investigator
Theresa Morrison, PhD
NCH Healthcare System Inc

Theresa Morrison, PhD
Phone: 239-624-4384
Email: theresa.morrison@nchmd.org


Backup Contact:

Email: laurie.zonesmith@nchmd.org
Laurie Zone-Smith, PhD
Phone: 239-624-4986


Location Contact:

Naples, Florida 34102
United States

Theresa L Morrison, PhD
Phone: 239-624-4384
Email: theresa.morrison@nchmd.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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