<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/NCT02969460</url>
  </required_header>
  <id_info>
    <org_study_id>EH-003</org_study_id>
    <nct_id>NCT02969460</nct_id>
  </id_info>
  <brief_title>Neurotrack Virtual Cognitive Health Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Evidation Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Neurotrack</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Evidation Health</source>
  <brief_summary>
    <textblock>
      The Neurotrack Virtual Cognitive Health Study is a 12-month long, prospective study that aims&#xD;
      to evaluate the impact of the Neurotrack Virtual Cognitive Health Coaching Program on&#xD;
      cognitive ability, anxiety and depression, and lifestyle behaviors for individuals who show&#xD;
      signs of subjective cognitive decline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2016</start_date>
  <completion_date type="Actual">April 18, 2018</completion_date>
  <primary_completion_date type="Actual">April 18, 2018</primary_completion_date>
  <phase>N/A</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>RBANS score</measure>
    <time_frame>week 24</time_frame>
    <description>Repeatable Battery for the Assessment of Neuropsychological Status total score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RBANS score</measure>
    <time_frame>week 52</time_frame>
    <description>Repeatable Battery for the Assessment of Neuropsychological Status total score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PHQ-9</measure>
    <time_frame>week 24</time_frame>
    <description>Patient-health questionnaire 9-item scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PHQ-9</measure>
    <time_frame>week 52</time_frame>
    <description>Patient-health questionnaire 9-item scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GAD-7</measure>
    <time_frame>week 24</time_frame>
    <description>Generalized anxiety disorder 7-item scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GAD-7</measure>
    <time_frame>week 52</time_frame>
    <description>Generalized anxiety disorder 7-item scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Subjective Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Neurotrack Virtual Cognitive Health Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This program is a multi-domain lifestyle intervention designed to prevent or delay cognitive decline and impairment in older at-risk adults. The first 6 months of the program emphasizes lifestyle change, while the last 6 months of the program emphasizes habit reinforcement. The program focuses on nutrition, physical exercise, and cognitive training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neurotrack Virtual Cognitive Health Program</intervention_name>
    <arm_group_label>Neurotrack Virtual Cognitive Health Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 60-75&#xD;
&#xD;
          -  Individuals who show signs of subjective cognitive decline (assessed by scoring ≥ 1 on&#xD;
             the Subjective Cognitive Decline [Short Form] Questionnaire and endorsing the Personal&#xD;
             Worry Item on the questionnaire)&#xD;
&#xD;
          -  Have the ability to make and receive phone calls&#xD;
&#xD;
          -  Have the ability to send and receive text messages&#xD;
&#xD;
          -  Access to a desktop computer, video-teleconferencing and reliable internet connection&#xD;
&#xD;
          -  Motivated to use a daily coaching program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant history of mental illness, substance abuse, learning disability, or&#xD;
             neurologic conditions&#xD;
&#xD;
          -  History of dementia&#xD;
&#xD;
          -  Ophthalmologic/visual problems that prevent individual from viewing a computer screen&#xD;
             at a normal distance (e.g., legal blindness, detached retinas, occlusive cataracts)&#xD;
&#xD;
          -  Currently participating in a formal cognitive-training coaching program&#xD;
&#xD;
          -  Currently pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Evidation Health</name>
      <address>
        <city>San Mateo</city>
        <state>California</state>
        <zip>94401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2018</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>Cognitive Dysfunction</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/NCT02969460
org study id: EH-003
nct id: NCT02969460
lead sponsor: 
collaborator: 
The Neurotrack Virtual Cognitive Health Study is a 12-month long, prospective study that aims
      to evaluate the impact of the Neurotrack Virtual Cognitive Health Coaching Program on
      cognitive ability, anxiety and depression, and lifestyle behaviors for individuals who show
      signs of subjective cognitive decline.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: RBANS score
time frame: week 24
description: Repeatable Battery for the Assessment of Neuropsychological Status total score
measure: RBANS score
time frame: week 52
description: Repeatable Battery for the Assessment of Neuropsychological Status total score
measure: PHQ-9
time frame: week 24
description: Patient-health questionnaire 9-item scale
measure: PHQ-9
time frame: week 52
description: Patient-health questionnaire 9-item scale
measure: GAD-7
time frame: week 24
description: Generalized anxiety disorder 7-item scale
measure: GAD-7
time frame: week 52
description: Generalized anxiety disorder 7-item scale
arm group label: Neurotrack Virtual Cognitive Health Program
arm group type: Experimental
description: This program is a multi-domain lifestyle intervention designed to prevent or delay cognitive decline and impairment in older at-risk adults. The first 6 months of the program emphasizes lifestyle change, while the last 6 months of the program emphasizes habit reinforcement. The program focuses on nutrition, physical exercise, and cognitive training.
intervention type: Behavioral
intervention name: Neurotrack Virtual Cognitive Health Program
arm group label: Neurotrack Virtual Cognitive Health Program
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction