<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/NCT04413851</url>
  </required_header>
  <id_info>
    <org_study_id>HM060401</org_study_id>
    <nct_id>NCT04413851</nct_id>
  </id_info>
  <brief_title>Feasibility of Passive Data Collection in Dementia Subjects With Agitation</brief_title>
  <official_title>A Feasibility Study to Evaluate Passive Collection of Activity Data in Subjects With Agitation in the Context of Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthMode Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HealthMode Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, observational, feasibility study, to evaluate long term passive data&#xD;
      collection, data quality, and user experience of HealthMode Agitation (Apps) to collect&#xD;
      motion, location, physiological, and audio data; and eCOA and EMA responses with mobile&#xD;
      devices (iPhone, Apple Watch).&#xD;
&#xD;
      The purpose of this study is to evaluate and improve HealthMode Apps data collection and&#xD;
      usability in subjects experiencing agitation in the context of dementia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">December 6, 2021</completion_date>
  <primary_completion_date type="Actual">December 6, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of passive and continuous data collection</measure>
    <time_frame>28 days</time_frame>
    <description>Total time and percentage of continuous data collection for each stream of data aiming for &gt;50% coverage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability of carrying a smartphone and wearing a data collection sensor on the wrist and/or hand in a population of subjects who may have frequent episodes of agitation or impulsive behavior.</measure>
    <time_frame>28 days</time_frame>
    <description>Caregiver and Staff engagement with the eCOA and EMA (threshold 80% completion) and responses to usability questionnaires at week 1 and 4 to provide feedback on comfort, usability and engagement. The score ranges from 10 to 50, higher score indicating a better usability.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Suitability of individual data streams and their combinations for purposes of identification of agitation episodes in passively collected data.</measure>
    <time_frame>28 days</time_frame>
    <description>Comparison of data collected from the smartphone and wearable device to episodes identified by subject or caregiver assessment:&#xD;
Cleaned single channel data compared to assessments&#xD;
Cleaned multichannel data compared to assessments&#xD;
Analyzed multichannel data compared to assessments&#xD;
Subject/Caregiver assessment data compared to agitation scale ratings&#xD;
Agitation scale ratings compared to cleaned single and multichannel data and analyzed multichannel data.&#xD;
Merged subject/caregiver assessment and multichannel data compared to agitation scale ratings</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Dementia</condition>
  <condition>Alzheimer Disease</condition>
  <condition>Vascular Dementia</condition>
  <condition>Frontotemporal Dementia</condition>
  <condition>Lewy Body Dementia</condition>
  <condition>Mixed Dementia</condition>
  <arm_group>
    <arm_group_label>Dementia</arm_group_label>
    <description>Subjects with a diagnosis of dementia who are experiencing agitation severe enough that it interferes with activities of daily living or social interaction.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible individuals who have a diagnosis of dementia and a recent history of agitation&#xD;
        will sign an informed consent, with a legally authorized representative (LAR) when&#xD;
        necessary, to enroll in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects 18 years and older.&#xD;
&#xD;
          -  Subjects who have met DSM-5 criteria for Dementia (all cause)&#xD;
&#xD;
          -  Subjects with a recent history of agitation in the past 6 months to a point that&#xD;
             impairs social activities, requires staffing or medical intervention (kick, bite,&#xD;
             flailing, etc.), impairs ability for functional activities of daily living, as&#xD;
             disclosed by a caregiver or documented in the medical record.&#xD;
&#xD;
          -  Subjects resident in a group home, nursing home, or assisted living are eligible to&#xD;
             participate.&#xD;
&#xD;
          -  Subjects who can read, understand and provide written informed consent or who have a&#xD;
             Legally Acceptable Representative (LAR)&#xD;
&#xD;
          -  Subjects who are willing and able to carry a smartphone and wear an activity tracker&#xD;
             on their wrist or hand, alone or with the help of a caregiver.&#xD;
&#xD;
          -  Subjects who, either alone or with a caregiver, are able to operate a smartphone and&#xD;
             wrist or hand-worn activity tracker, alone or with the help of a caregiver.&#xD;
&#xD;
          -  Subjects who are in good general health prior to study participation as determined by&#xD;
             a detailed medical history, and in the opinion of the Principal Investigator.&#xD;
&#xD;
          -  Subjects, who are able to ambulate without an assistive device, or with a single point&#xD;
             cane.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are unwilling or unable to carry a smartphone and wear an activity&#xD;
             tracker on their wrist or hand.&#xD;
&#xD;
          -  Subjects with serious or unstable medical illnesses. These include current hepatic&#xD;
             (moderate-severe hepatic impairment), renal, gastroenterological, respiratory,&#xD;
             cardiovascular (including ischemic heart disease, congestive heart failure),&#xD;
             endocrinologic, neurologic or hematologic disease.&#xD;
&#xD;
          -  Subjects who are considered by the investigator, for any reason, to be an unsuitable&#xD;
             candidate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tucson Neuroscience Research, LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtual Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>December 16, 2021</last_update_submitted>
  <last_update_submitted_qc>December 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2021</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>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Frontotemporal Dementia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Dementia, Vascular</mesh_term>
    <mesh_term>Lewy Body Disease</mesh_term>
    <mesh_term>Mixed Dementias</mesh_term>
  </condition_browse>
  <!-- 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/NCT04413851
org study id: HM060401
nct id: NCT04413851
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multi-center, observational, feasibility study, to evaluate long term passive data
      collection, data quality, and user experience of HealthMode Agitation (Apps) to collect
      motion, location, physiological, and audio data; and eCOA and EMA responses with mobile
      devices (iPhone, Apple Watch).

      The purpose of this study is to evaluate and improve HealthMode Apps data collection and
      usability in subjects experiencing agitation in the context of dementia.
observational model: Cohort
time perspective: Prospective
measure: Feasibility of passive and continuous data collection
time frame: 28 days
description: Total time and percentage of continuous data collection for each stream of data aiming for >50% coverage.
measure: Tolerability of carrying a smartphone and wearing a data collection sensor on the wrist and/or hand in a population of subjects who may have frequent episodes of agitation or impulsive behavior.
time frame: 28 days
description: Caregiver and Staff engagement with the eCOA and EMA (threshold 80% completion) and responses to usability questionnaires at week 1 and 4 to provide feedback on comfort, usability and engagement. The score ranges from 10 to 50, higher score indicating a better usability.
measure: Suitability of individual data streams and their combinations for purposes of identification of agitation episodes in passively collected data.
time frame: 28 days
description: Comparison of data collected from the smartphone and wearable device to episodes identified by subject or caregiver assessment:
Cleaned single channel data compared to assessments
Cleaned multichannel data compared to assessments
Analyzed multichannel data compared to assessments
Subject/Caregiver assessment data compared to agitation scale ratings
Agitation scale ratings compared to cleaned single and multichannel data and analyzed multichannel data.
Merged subject/caregiver assessment and multichannel data compared to agitation scale ratings
arm group label: Dementia
description: Subjects with a diagnosis of dementia who are experiencing agitation severe enough that it interferes with activities of daily living or social interaction.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Frontotemporal Dementia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Dementia, Vascular
mesh term: Lewy Body Disease
mesh term: Mixed Dementias