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Completed

NCT Number: NCT02659982

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

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

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Key information

Conditions

Post Cardiac Surgery

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheba Medical Center

Ramat Gan, Israel

About this study

Study objectives include:

  • 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).
  • 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).
  • Assess the acceptability of the EarlySense Home care device by clinicians
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 30 days

    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

  2. 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

    Time frame: 30 days

    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

  3. 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

    Time frame: 30 days

    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

  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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

EarlySense Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 21, 2016
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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