Evaluation of EarlySense Home Care Tele-monitoring Device

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02318004
• Other study ID #: SHEBA-14-0987-RK-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 7, 2014
• Last updated: December 11, 2014
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: December 2014
• Source: Sheba Medical Center
• Contact: Robert Klempfner, MD
• Email: klempfner[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiac Surgery
• Myocardial Infarction

Intervention

Other:
• Home Monitoring
Non invasive nocturnal monitoring of heart and respiratory rate and subjects movement out of bed.

Locations

Country	Name	City	State
Israel	SheLev, Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	EarlySense Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Zimlichman E, Shinar Z, Rozenblum R, Levkovich S, Skiano S, Szyper-Kravitz M, Altman A, Amital H, Shoenfeld Y. Using continuous motion monitoring technology to determine patient's risk for development of pressure ulcers. J Patient Saf. 2011 Dec;7(4):181-4. doi: 10.1097/PTS.0b013e318230e6ef. — View Citation

Zimlichman E, Szyper-Kravitz M, Shinar Z, Klap T, Levkovich S, Unterman A, Rozenblum R, Rothschild JM, Amital H, Shoenfeld Y. Early recognition of acutely deteriorating patients in non-intensive care units: assessment of an innovative monitoring technology. J Hosp Med. 2012 Oct;7(8):628-33. doi: 10.1002/jhm.1963. Epub 2012 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnositic Utility	Positive percent agreement between the EarlySense device and clinical events as adjudicated by health-care personal	30 days following enrollment	No
Secondary	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	No