Evaluation of EarlySense Home Care Tele-monitoring Device -For Early Detection of Deterioration For Cardiac Patients at Home

Post Cardiac Surgery 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: Completed

Administrative data

• NCT number: NCT02659982
• Other study ID #: CLN-H-003-2013
• Status: Completed
• Phase: N/A
• First received: December 28, 2015
• Last updated: August 1, 2017
• Start date: April 2015
• Est. completion date: April 2017

Study information

• Verified date: September 2016
• Source: EarlySense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the relevance of the information as provided by the EarlySense Home care Tele-monitoring system can provide relevant flagging information for clinicians to identify the patients at higher risk to proactively assess patients' condition

Description:

Study objectives include:

1. Assess if and to what extent the flags provided by EarlySense Home care tele-monitoring provides relevant clinical information that can help case managers / nurses of home care agency to detect patients who need further assessment and perhaps early intervention to minimize hospitalization (re-admission to hospital).

2. Use data to further optimize a decision algorithm utilizing changes in physiological data over time (i.e., hours to days) which may identify patients at higher risk for poor outcomes (flagging algorithm).

3. Assess the acceptability of the EarlySense Home care device by clinicians

4. Assess the acceptability of the EarlySense Home care device by patients at home and their families, in their own home as determined by a provided questioner

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age 21 and up

• Any patient hosted in Shelev with geographically resident over 50 km from Sheba Medical Center/ Shelev

• Patients agrees to sign the consent form and comply with study protocol.

Exclusion Criteria:

• Patients do not agree to sign the consent form

• Planned readmission within 30 days of discharge from hospital

• Going home to hospice care.

• Patients with cognitive constraints or disabilities

Related Conditions & MeSH terms

• Post Cardiac Surgery

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
EarlySense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate if Alerts and Flags generated by the EarlySense Home Care System, could have potentially prevented readmission to hospitals, and providing better care at home, for post cardiac surgery patients	Evaluate the usability of Home Monitoring System for Heart Rate (BPM), in providing help to nurses, evaluating the overall clinical situation of post cardiac petients at home	30 days
Primary	To evaluate if Alerts and Flags generated by the EarlySense Home Care System, could have potentially prevented readmission to hospitals, and providing better care at home, for post cardiac surgery patients	Evaluate the usability of Home Monitoring System for Respiratory Rate (Br./min), in providing help to nurses, evaluating the overall clinical situation of post cardiac petients at home	30 days
Primary	To evaluate if Alerts and Flags generated by the EarlySense Home Care System, could have potentially prevented readmission to hospitals, and providing better care at home, for post cardiac surgery patients	Evaluate the usability of Home Monitoring System for activity indication such asnumber of bed exits during nighttime in providing help to nurses, evaluating the overall clinical situation of post cardiac petients at home	30 days
Primary	To evaluate if Alerts and Flags generated by the EarlySense Home Care System, could have potentially prevented readmission to hospitals, and providing better care at home, for post cardiac surgery patients	Evaluate the usability of Home Monitoring System activity indication such as number of hours spent in bed during the day in providing help to nurses, evaluating the overall clinical situation of post cardiac petients at home	30 days