Clinical trial NCT02659982: Evaluation of EarlySense Home Care Tele-monitoring Device -For Early Detection of Deterioration For Cardiac Patients at Home
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Cardiac Surgery
Lead sponsor: EarlySense Ltd.
Sponsor class: INDUSTRY
First posted: 2016-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post Cardiac Surgery

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 30 days
measure: 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
timeFrame: 30 days
measure: 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
timeFrame: 30 days
measure: 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
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: