Evaluation of EarlySense Home Care Tele-monitoring Device

December 11, 2014 updated by: Sheba Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • SheLev, Sheba Medical Center
        • Contact:
        • Sub-Investigator:
          • David Rott, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who resided in Shelev following a cardiac event (cardiac surgery, myocardial infarction, pacemaker implantation or other cardiac interventions )
  2. Age ≥ 21 years
  3. Any patient hosted in Shelev with geographically resident within 50 Km from Sheba Medical Center
  4. Patients agrees to sign the consent form and able to comply with study protocol.
  5. Sleeps on a mattress

Exclusion Criteria:

  1. Planned readmission within 30 days of discharge from hospital
  2. Discharge to hospice care.
  3. Patients with cognitive disabilities
  4. Patient's major treating hospital is not the Sheba Medical Center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home monitoring
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
Non invasive nocturnal monitoring of heart and respiratory rate and subjects movement out of bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnositic Utility
Time Frame: 30 days following enrollment
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
Time Frame: 30 days following enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

EarlySense Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

December 7, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-14-0987-RK-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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