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

NCT02659982 | Completed DMC

• 1 other identifier: CLN-H-003-2013
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Post Cardiac Surgery

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post Cardiac Surgery

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• EarlySense Ltd.: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: January 21, 2016
• Study Start: April 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 2, 2017

Record last verified: 2016-09

Locations

IL (1)