<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/NCT04478149</url>
  </required_header>
  <id_info>
    <org_study_id>241755</org_study_id>
    <nct_id>NCT04478149</nct_id>
  </id_info>
  <brief_title>A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study</brief_title>
  <official_title>A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SafelyYou</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SafelyYou</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tests novel technology using computer vision and remote clinical review to reduce&#xD;
      falls for residents with dementia in assisted living communities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 31, 2023</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Waitlist control</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opt-in rate</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>participants enrolling</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of falls</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>fall incidents</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of ER visits</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>fall incidents requiring emergency transportation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Active Cameras</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>active cameras in the room</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inactive Cameras</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>camera in the room, not activated</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SafelyYou</intervention_name>
    <description>technology to detect and prevent falls</description>
    <arm_group_label>Active Cameras</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>technology present but not activated</description>
    <arm_group_label>Inactive Cameras</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Living in a participating assisted living facility and suffering from dementia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04478149
org study id: 241755
nct id: NCT04478149
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study tests novel technology using computer vision and remote clinical review to reduce
      falls for residents with dementia in assisted living communities.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Waitlist control
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: Opt-in rate
time frame: through study completion, an average of 1 year
description: participants enrolling
measure: Number of falls
time frame: through study completion, an average of 1 year
description: fall incidents
measure: Number of ER visits
time frame: through study completion, an average of 1 year
description: fall incidents requiring emergency transportation
arm group label: Active Cameras
arm group type: Experimental
description: active cameras in the room
arm group label: Inactive Cameras
arm group type: Sham Comparator
description: camera in the room, not activated
intervention type: Device
intervention name: SafelyYou
description: technology to detect and prevent falls
arm group label: Active Cameras
intervention type: Other
intervention name: Control
description: technology present but not activated
arm group label: Inactive Cameras
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Dementia
sharing ipd: No