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

Completed

• Conditions: Post Cardiac Surgery

• Registration Number: NCT02659982
• Lead Sponsor: EarlySense Ltd.

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

Detailed 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

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2016-01-16
• Study First Posted: 2016-01-21
• Status Verified: 2016-09
• Primary Completion: 2017-02
• Study Completion: 2017-04
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	30 days	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

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel