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

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ClinicalTrials.gov Identifier: NCT02659982
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Post Cardiac Surgery

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

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : April 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : April 2017



Primary Outcome Measures :
  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



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post Cardiac Surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659982


Locations
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Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
EarlySense Ltd.
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Responsible Party: EarlySense Ltd.
ClinicalTrials.gov Identifier: NCT02659982    
Other Study ID Numbers: CLN-H-003-2013
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided