NCT03003663

Brief Summary

The purpose of this study is to determine the effect of an Internet-of-Things bed fall solution when used in a hospital setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
658

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

December 12, 2016

Last Update Submit

February 22, 2018

Conditions

Accidental Fall From BedPatient Fall

Keywords

Fall PreventionInterrupted Time-Series StudyPatient SafetyPatient-Centered CarePatient MonitoringHealth Care TechnologyMobile ApplicationsBedside MonitorMechanical Fall

Outcome Measures

Primary Outcomes (1)

  • Fall Rate

    18 months

Study Arms (1)

SensableCare System

EXPERIMENTAL

Device:The interrupted time series design will alternate between the following on a monthly basis: (1) standard medical care and (2) standard medical care and the SensableCare System.

Device: SensableCare System

Interventions

SensableCare SystemDEVICE

The SensableCare System is evaluated for reducing bed falls.

SensableCare System

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • inpatient
  • consents to study (family members may sign on behalf of patients unable to consent)
  • high fall risk patient (assessed fall risk score greater than or equal to 3 points

You may not qualify if:

  • unable to cooperate
  • under quarantine
  • using special mattresses (cushion pad, air mattresses)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Pei-Tou District, Taiwan

Location

Study Officials

  • Ging-Long Wang, MD, MPH

    Koo Foundation Sun Yat-Sen Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 28, 2016

Study Start

March 1, 2016

Primary Completion

June 6, 2017

Study Completion

December 6, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

TW(1)