<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03003663</url>
  </required_header>
  <id_info>
    <org_study_id>20150701A</org_study_id>
    <nct_id>NCT03003663</nct_id>
  </id_info>
  <brief_title>Interrupted Time-Series Study for In-hospital Fall Reduction</brief_title>
  <official_title>Interrupted Time-Series Study for In-hospital Fall Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedicusTek, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedicusTek, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of an Internet-of-Things bed fall&#xD;
      solution when used in a hospital setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the effect of an Internet-of-Things bed fall&#xD;
      solution when used in a hospital setting.&#xD;
&#xD;
      The study evaluates the SensableCare System for reducing bed falls. The SensableCare System&#xD;
      will be used in three units of a hospital. It will be turned off for one month for the&#xD;
      control group and then turned on the next month for the intervention group, repeating this&#xD;
      sequence until the study concludes. To better inform the data analysis, the investigators&#xD;
      collect baseline patient characteristics, fall risk scores, and the unit fall rate every&#xD;
      month.&#xD;
&#xD;
      The SenableCare System: A pressure sensor pad is placed between the mattress surface and the&#xD;
      bed sheet. The system lets nurses know how the patient is positioned in bed at the time of&#xD;
      the alert, from which room number the alert is being generated, and informs other nurses when&#xD;
      a patient is being assisted.&#xD;
&#xD;
      Using a predictive algorithm, the system can also monitor patient position in bed and send&#xD;
      specific, customized alerts if nurses want to know when a patient begins to stir in bed, sits&#xD;
      up in bed, attempts to leave the bed, or is already out of bed. When the system's software&#xD;
      algorithm detects an increased probability of a bed exit, the system alerts the nursing staff&#xD;
      via an app on mobile devices (i.e., smartphones) that nurses carry and via a dashboard at the&#xD;
      nursing station. When the patient attempts to leave the bed, an audible message coming from a&#xD;
      control box next to the patient's bed reminds the patient not to leave and that a nurse will&#xD;
      arrive shortly. Concurrently, nurses receive alerts at a dashboard and through their&#xD;
      smartphones via audible, vibratory, and visual alerts prompting a rapid response. Nurses&#xD;
      respond to the alerts by tapping a control box in the patient room or returning the patient&#xD;
      back to bed; this turns off alerts at the dashboard and on other nurses' smartphones.&#xD;
&#xD;
      Nurses can customize each individual patient's alert settings. Nurses receive bed leaving&#xD;
      alerts when the System detects the patient is attempting to leave the bed or is out of the&#xD;
      bed. Nurses may also choose to receive alerts when a patient is stirring after being still&#xD;
      for &gt;20 minutes and/or when a patient is sitting up in bed. Both the nurse and nurse aide&#xD;
      responsible for an enrolled patient receive alerts directly through their smartphones via a&#xD;
      real-time push notification. The charge nurse at the nursing station also receives alerts&#xD;
      through the SensableCare app on the dashboard.&#xD;
&#xD;
      Standard medical care: A standard bed fall alarm or no alarm is used as standard medical&#xD;
      care. The three trial units only have two bed fall alarms available for high fall risk&#xD;
      patients. Those who do not consent to the study use this standard bed fall alarm or none at&#xD;
      all. The standard bed fall alarm signals when a patient is exiting the bed via an audible&#xD;
      alert. The nurses listen for the sound and go to the room to assist the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">December 6, 2017</completion_date>
  <primary_completion_date type="Actual">June 6, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fall Rate</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">658</enrollment>
  <condition>Accidental Fall From Bed</condition>
  <condition>Patient Fall</condition>
  <arm_group>
    <arm_group_label>SensableCare System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SensableCare System</intervention_name>
    <description>The SensableCare System is evaluated for reducing bed falls.</description>
    <arm_group_label>SensableCare System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  inpatient&#xD;
&#xD;
          -  consents to study (family members may sign on behalf of patients unable to consent)&#xD;
&#xD;
          -  high fall risk patient (assessed fall risk score greater than or equal to 3 points&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to cooperate&#xD;
&#xD;
          -  under quarantine&#xD;
&#xD;
          -  using special mattresses (cushion pad, air mattresses)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ging-Long Wang, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Koo Foundation Sun Yat-Sen Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Koo Foundation Sun Yat-Sen Cancer Center</name>
      <address>
        <city>Taipei</city>
        <state>Pei-Tou District</state>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>February 22, 2018</last_update_submitted>
  <last_update_submitted_qc>February 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fall Prevention</keyword>
  <keyword>Interrupted Time-Series Study</keyword>
  <keyword>Patient Safety</keyword>
  <keyword>Patient-Centered Care</keyword>
  <keyword>Patient Monitoring</keyword>
  <keyword>Health Care Technology</keyword>
  <keyword>Mobile Applications</keyword>
  <keyword>Bedside Monitor</keyword>
  <keyword>Mechanical Fall</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03003663
org study id: 20150701A
nct id: NCT03003663
lead sponsor: 
has dmc: No
The purpose of this study is to determine the effect of an Internet-of-Things bed fall
      solution when used in a hospital setting.
The purpose of this study is to determine the effect of an Internet-of-Things bed fall
      solution when used in a hospital setting.

      The study evaluates the SensableCare System for reducing bed falls. The SensableCare System
      will be used in three units of a hospital. It will be turned off for one month for the
      control group and then turned on the next month for the intervention group, repeating this
      sequence until the study concludes. To better inform the data analysis, the investigators
      collect baseline patient characteristics, fall risk scores, and the unit fall rate every
      month.

      The SenableCare System: A pressure sensor pad is placed between the mattress surface and the
      bed sheet. The system lets nurses know how the patient is positioned in bed at the time of
      the alert, from which room number the alert is being generated, and informs other nurses when
      a patient is being assisted.

      Using a predictive algorithm, the system can also monitor patient position in bed and send
      specific, customized alerts if nurses want to know when a patient begins to stir in bed, sits
      up in bed, attempts to leave the bed, or is already out of bed. When the system's software
      algorithm detects an increased probability of a bed exit, the system alerts the nursing staff
      via an app on mobile devices (i.e., smartphones) that nurses carry and via a dashboard at the
      nursing station. When the patient attempts to leave the bed, an audible message coming from a
      control box next to the patient's bed reminds the patient not to leave and that a nurse will
      arrive shortly. Concurrently, nurses receive alerts at a dashboard and through their
      smartphones via audible, vibratory, and visual alerts prompting a rapid response. Nurses
      respond to the alerts by tapping a control box in the patient room or returning the patient
      back to bed; this turns off alerts at the dashboard and on other nurses' smartphones.

      Nurses can customize each individual patient's alert settings. Nurses receive bed leaving
      alerts when the System detects the patient is attempting to leave the bed or is out of the
      bed. Nurses may also choose to receive alerts when a patient is stirring after being still
      for >20 minutes and/or when a patient is sitting up in bed. Both the nurse and nurse aide
      responsible for an enrolled patient receive alerts directly through their smartphones via a
      real-time push notification. The charge nurse at the nursing station also receives alerts
      through the SensableCare app on the dashboard.

      Standard medical care: A standard bed fall alarm or no alarm is used as standard medical
      care. The three trial units only have two bed fall alarms available for high fall risk
      patients. Those who do not consent to the study use this standard bed fall alarm or none at
      all. The standard bed fall alarm signals when a patient is exiting the bed via an audible
      alert. The nurses listen for the sound and go to the room to assist the patient.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Fall Rate
time frame: 18 months
arm group label: SensableCare System
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: SensableCare System
description: The SensableCare System is evaluated for reducing bed falls.
arm group label: SensableCare System
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ging-Long Wang, MD, MPH
role: Principal Investigator
affiliation: Koo Foundation Sun Yat-Sen Cancer Center
facility: 
country: Taiwan
responsible party type: Sponsor