Determine Return on Investment in Heart Failure Remote Monitoring Program

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Peripherals with HealthInterlink technology


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Control: Peripherals with HealthInterlink technology will record and transmit data, without intervention. Subject is able to view graphed data, bring the HealthInterlink tablet/smartphone to the physician's office and share data with family/other caregiver. | Device: Peripherals with HealthInterlink technology<br>* home remote monitoring<br>* Other names: tablet/smartphone-based technology;|
| Experimental: Intervention 1<br>Intervention 1: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver. | Device: Peripherals with HealthInterlink technology<br>* home remote monitoring<br>* Other names: tablet/smartphone-based technology;|
| Experimental: Intervention 2<br>Intervention 2: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver, and a call will be placed by the nurse research assistant to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts). The physicians will have access to the subject's data on a web-based program. | Device: Peripherals with HealthInterlink technology<br>* home remote monitoring<br>* Other names: tablet/smartphone-based technology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization) | 31 days post discharge with a heart failure-related hospital re-hospitalization. | 31 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication with healthcare provider or emergency department | Communication that resulted in unplanned healthcare provider office visits or visit to emergency department | 31 days | 
| Number of non-conformity issues | Number of non-conformity telephone reminder texts, emails, and/or calls. | 31 days | 
| Health-related quality of life Questionnaire | Health-related quality of life | 31 days | 
| Subject satisfaction Questionnaire | Subject satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use, time to complete testing and questionnaire, benefit that promoted better health | 31 days | 
| Physician satisfaction Questionnaire | Physician satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use of software, benefit that promoted better communication with subject. | 31 days | 
| Cost of system and intervention per subjects | Economic viability of remote monitoring program based on daily cost of system and intervention per subjects in comparison with control and treatment groups. | 31 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, heart failure, home blood pressure monitoring