Clinical trial NCT02318004: Evaluation of EarlySense Home Care Tele-monitoring Device
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Cardiac Surgery
Keywords: telemonitoring
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: EarlySense Ltd.
First posted: 2014-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnositic Utility
timeFrame: 30 days following enrollment
Secondary outcomes:
measure: System Acceptance
timeFrame: 30 days following enrollment
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: SheLev, Sheba Medical Center
Study officials:
References:
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.
citation: 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.