NCT02318004

Brief Summary

The aims of the present study are to evaluate the information obtained by the EarlySenese monitoring system and examine correlation of the obtained data and clinical events.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

December 7, 2014

Last Update Submit

December 11, 2014

Conditions

Myocardial InfarctionCardiac Surgery

Keywords

telemonitoring

Outcome Measures

Primary Outcomes (1)

  • Diagnositic Utility

    Positive percent agreement between the EarlySense device and clinical events as adjudicated by health-care personal

    30 days following enrollment

Secondary Outcomes (1)

  • System Acceptance

    30 days following enrollment

Study Arms (1)

Home monitoring

EXPERIMENTAL

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.

Other: Home Monitoring

Interventions

Home MonitoringOTHER

Non invasive nocturnal monitoring of heart and respiratory rate and subjects movement out of bed.

Home monitoring

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who resided in Shelev following a cardiac event (cardiac surgery, myocardial infarction, pacemaker implantation or other cardiac interventions )
  • Age ≥ 21 years
  • Any patient hosted in Shelev with geographically resident within 50 Km from Sheba Medical Center
  • Patients agrees to sign the consent form and able to comply with study protocol.
  • Sleeps on a mattress

You may not qualify if:

  • Planned readmission within 30 days of discharge from hospital
  • Discharge to hospice care.
  • Patients with cognitive disabilities
  • Patient's major treating hospital is not the Sheba Medical Center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SheLev, Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Related Publications (2)

  • 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.

    PMID: 22865462BACKGROUND

  • 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.

    PMID: 21926639BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative Techniques

Central Study Contacts

Robert Klempfner, MD

CONTACT

klempfner@gmail.com

Meirav Moreno, Msc

CONTACT

Merav.Moreno@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2014

First Posted

December 17, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

December 17, 2014

Record last verified: 2014-12

Locations

IL(1)