Evaluation of EarlySense Home Care Tele-monitoring Device
NCT ID: NCT02318004
Last Updated: 2014-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2014-12-31
2016-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The system, which monitors the patient while in bed, consists of a piezoelectric sensor that produces an electrical signal in response to physiological stimulation, and a microprocessor control unit that analyzes the recorded signal and identifies respiratory and heart rates and patient motion, while patient is in bed,. In addition, the system indicates patient's in or out of bed status. The system also provides alerts if either of the physiological parameters cross predefined threshold settings (e.g., high/ low heart rate or respiratory rate, or motion or time in bed).
The system saves patient's parameters and then flags the patients, as those to have changes in their vital signs and motion, or those that do not have noteworthy changes during recent hours of monitoring. Flagging of the patients are based on changes detected in patients' baseline vital signs (heart and respiratory rates and patterns) and well as recognition of changes in patients motion and in and out of bed status in comparison to set thresholds.
The aim of this study is to evaluate relevance of the information (vital sign trends, alerts and flags) as provided by the EarlySense Home Care Tele-monitoring system to medical staff in Sheba Medical Center's Heart Rehabilitation Institute (Shelev) in order proactively monitor patients at home. The correlation between the EarlySense system alerts and flags to patient deterioration and hospital readmission will be studied.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Home monitoring
Home monitoring via the EarlySense non-invasive nocturnal monitoring system. Movement, heart rate and respiratory rates will be monitored while subject is in his bed. The trends of monitored values will be daily reported to a central repository. No intervention will be attempted and care will be coordinated by the family physician and treating cardiologist as usual.
Home Monitoring
Non invasive nocturnal monitoring of heart and respiratory rate and subjects movement out of bed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Home Monitoring
Non invasive nocturnal monitoring of heart and respiratory rate and subjects movement out of bed.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥ 21 years
3. Any patient hosted in Shelev with geographically resident within 50 Km from Sheba Medical Center
4. Patients agrees to sign the consent form and able to comply with study protocol.
5. Sleeps on a mattress
Exclusion Criteria
2. Discharge to hospice care.
3. Patients with cognitive disabilities
4. Patient's major treating hospital is not the Sheba Medical Center
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
EarlySense Ltd.
INDUSTRY
Sheba Medical Center
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SheLev, Sheba Medical Center
Ramat Gan, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Robert Klempfner, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Zimlichman E, Szyper-Kravitz M, Shinar Z, Klap T, Levkovich S, Unterman A, Rozenblum R, Rothschild JM, Amital H, Shoenfeld Y. Early recognition of acutely deteriorating patients in non-intensive care units: assessment of an innovative monitoring technology. J Hosp Med. 2012 Oct;7(8):628-33. doi: 10.1002/jhm.1963. Epub 2012 Aug 3.
Zimlichman E, Shinar Z, Rozenblum R, Levkovich S, Skiano S, Szyper-Kravitz M, Altman A, Amital H, Shoenfeld Y. Using continuous motion monitoring technology to determine patient's risk for development of pressure ulcers. J Patient Saf. 2011 Dec;7(4):181-4. doi: 10.1097/PTS.0b013e318230e6ef.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHEBA-14-0987-RK-CTIL
Identifier Type: -
Identifier Source: org_study_id