<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/NCT03752697</url>
  </required_header>
  <id_info>
    <org_study_id>18123</org_study_id>
    <nct_id>NCT03752697</nct_id>
  </id_info>
  <brief_title>Metacognition in Neurological Injury</brief_title>
  <official_title>Longitudinal Examination of Metacognition in Neurological Samples</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska Lincoln</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quality Living, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nebraska Lincoln</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>
      The purpose of this study is to investigate the trajectory of metacognitive functioning&#xD;
      throughout phases of recovery from neurological insult, and to determine its relationship to&#xD;
      rehabilitation compliance and functional outcome. It is hypothesized that metacognitive&#xD;
      accuracy improves over time, and is a significant predictor of engagement in rehabilitation&#xD;
      activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine the trajectory of metacognitive functioning through different phases&#xD;
      of recovery from neurological insult, and document its relationship to rehabilitation&#xD;
      compliance. Individuals currently completing rehabilitation programs and individuals from the&#xD;
      community who meet study criteria are invited to participate. After consenting and enrolling&#xD;
      in the study, participants complete 2 study sessions: a baseline session, and a follow-up&#xD;
      session either at time of completion of rehabilitation program or 3 months later if not in a&#xD;
      rehabilitation program. During the study sessions, participants will complete&#xD;
      paper-and-pencil and computerized tests of cognition (including metacognitive tasks).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>Change from baseline metamemory performance to completion of rehabilitation</measure>
    <time_frame>At baseline and at end of length of stay in rehabilitative setting (on average 3 months)</time_frame>
    <description>The computerized metamemory test produces scores that are used to calculate a gamma coefficient, which is a quantitative measure of the individual's metacognitive performance/accuracy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in rehabilitative engagement</measure>
    <time_frame>At baseline and at end of length of stay in rehabilitative setting (on average 3 months)</time_frame>
    <description>The rehabilitative engagement questionnaire is a clinician-report measure that queries the clinician's perception of their client's participation in rehabilitation services.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Brain Injuries</condition>
  <arm_group>
    <arm_group_label>Neurological injury</arm_group_label>
    <description>Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <description>Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>metacognitive performance</intervention_name>
    <description>Paper and pencil/computerized tests of metacognition</description>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Neurological injury</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        participants in rehabilitation facility and community-dwelling individuals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history of brain and/or spinal cord injury&#xD;
&#xD;
          -  no history of brain or neurological injury/insult (for healthy control group)&#xD;
&#xD;
          -  fluent in spoken and written English&#xD;
&#xD;
          -  adequate gross motor abilities to provide a button push on a keyboard&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  exclusion criteria for healthy controls include:&#xD;
&#xD;
          -  current/past history of psychiatric illness&#xD;
&#xD;
          -  learning disorder&#xD;
&#xD;
          -  developmental disorder&#xD;
&#xD;
          -  diagnosis of Attention Deficit Disorder/Attention Deficit Hyperactive Disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathy Chiou, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska Lincoln</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kathy Chiou, Ph.D.</last_name>
    <phone>402-472-5843</phone>
    <email>kchiou2@unl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Nebraska-Lincoln</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68588-0308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathy Chiou, Ph.D.</last_name>
      <phone>402-472-5843</phone>
      <email>kchiou2@unl.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>October 20, 2022</last_update_submitted>
  <last_update_submitted_qc>October 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metacognition</keyword>
  <keyword>self-assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</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/NCT03752697
org study id: 18123
nct id: NCT03752697
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the trajectory of metacognitive functioning
      throughout phases of recovery from neurological insult, and to determine its relationship to
      rehabilitation compliance and functional outcome. It is hypothesized that metacognitive
      accuracy improves over time, and is a significant predictor of engagement in rehabilitation
      activities.
This study will examine the trajectory of metacognitive functioning through different phases
      of recovery from neurological insult, and document its relationship to rehabilitation
      compliance. Individuals currently completing rehabilitation programs and individuals from the
      community who meet study criteria are invited to participate. After consenting and enrolling
      in the study, participants complete 2 study sessions: a baseline session, and a follow-up
      session either at time of completion of rehabilitation program or 3 months later if not in a
      rehabilitation program. During the study sessions, participants will complete
      paper-and-pencil and computerized tests of cognition (including metacognitive tasks).
observational model: Cohort
time perspective: Prospective
measure: Change from baseline metamemory performance to completion of rehabilitation
time frame: At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
description: The computerized metamemory test produces scores that are used to calculate a gamma coefficient, which is a quantitative measure of the individual's metacognitive performance/accuracy.
measure: Change in rehabilitative engagement
time frame: At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
description: The rehabilitative engagement questionnaire is a clinician-report measure that queries the clinician's perception of their client's participation in rehabilitation services.
arm group label: Neurological injury
description: Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered.
arm group label: Healthy control
description: Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered.
intervention type: Behavioral
intervention name: metacognitive performance
description: Paper and pencil/computerized tests of metacognition
arm group label: Healthy control
arm group label: Neurological injury
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathy Chiou, Ph.D.
role: Principal Investigator
affiliation: University of Nebraska Lincoln
last name: Kathy Chiou, Ph.D.
phone: 402-472-5843
email: kchiou2@unl.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
sharing ipd: No