NCT02659982

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: EarlySense Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Conditions

• Post Cardiac Surgery

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-02-01
• Completion: 2017-04-01
• First posted: 2016-01-21
• Last updated: 2017-08-02

Locations

1 site across 1 country: Israel