Evaluation of EarlySense Home Care Tele-monitoring Device

Study Overview
=================
Brief Summary
-----------------
The aims of the present study are to evaluate the information obtained by the EarlySenese monitoring system and examine correlation of the obtained data and clinical events.

Detailed Description
-----------------
The EarlySense Home Care System developed by EarlySense, Ltd., is a contact-less tele-monitoring system. The system is intended for continuous monitoring of patients' respiration rate, heart rate and patient's motion. The system, which monitors the patient while in bed, consists of a piezoelectric sensor that produces an electrical signal in response to physiological stimulation, and a microprocessor control unit that analyzes the recorded signal and identifies respiratory and heart rates and patient motion, while patient is in bed,. In addition, the system indicates patient's in or out of bed status. The system also provides alerts if either of the physiological parameters cross predefined threshold settings (e.g., high/ low heart rate or respiratory rate, or motion or time in bed). The system saves patient's parameters and then flags the patients, as those to have changes in their vital signs and motion, or those that do not have noteworthy changes during recent hours of monitoring. Flagging of the patients are based on changes detected in patients' baseline vital signs (heart and respiratory rates and patterns) and well as recognition of changes in patients motion and in and out of bed status in comparison to set thresholds. The aim of this study is to evaluate relevance of the information (vital sign trends, alerts and flags) as provided by the EarlySense Home Care Tele-monitoring system to medical staff in Sheba Medical Center's Heart Rehabilitation Institute (Shelev) in order proactively monitor patients at home. The correlation between the EarlySense system alerts and flags to patient deterioration and hospital readmission will be studied.

Official Title
-----------------
Study Protocol for Evaluation of EarlySense Home Care Tele-monitoring Device - A Contact-Free System for Measuring Heart Rate, Respiratory Rate and Motion For Early Detection of Deterioration For Cardiac Patients at Home

Conditions
-----------------
Myocardial Infarction, Cardiac Surgery

Intervention / Treatment
-----------------
* Other: Home Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who resided in Shelev following a cardiac event (cardiac surgery, myocardial infarction, pacemaker implantation or other cardiac interventions ) Age ≥ 21 years Any patient hosted in Shelev with geographically resident within 50 Km from Sheba Medical Center Patients agrees to sign the consent form and able to comply with study protocol. Sleeps on a mattress Exclusion Criteria: Planned readmission within 30 days of discharge from hospital Discharge to hospice care. Patients with cognitive disabilities Patient's major treating hospital is not the Sheba Medical Center

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home monitoring<br>Home monitoring via the EarlySense non-invasive nocturnal monitoring system. Movement, heart rate and respiratory rates will be monitored while subject is in his bed. The trends of monitored values will be daily reported to a central repository. No intervention will be attempted and care will be coordinated by the family physician and treating cardiologist as usual. | Other: Home Monitoring<br>* Non invasive nocturnal monitoring of heart and respiratory rate and subjects movement out of bed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnositic Utility | Positive percent agreement between the EarlySense device and clinical events as adjudicated by health-care personal | 30 days following enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Acceptance | Assess the acceptability of the EarlySense Home care device by clinicians and by patients and their families in their own home as determined by a provided questioner. | 30 days following enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telemonitoring