<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/NCT02971124</url>
  </required_header>
  <id_info>
    <org_study_id>S59650</org_study_id>
    <nct_id>NCT02971124</nct_id>
  </id_info>
  <brief_title>Dr Solitaire: Assessing Cognitive Performance Through Meaningful Play</brief_title>
  <official_title>Observational Study to Assess Cognitive Performance in Elderly Life Via Meaning Play</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess cognitive performance by means of the game of Solitaire. In this study, the&#xD;
      investigators want to define relevant game metrics, when playing Solitaire, that may be&#xD;
      indicative of cognitive performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      12-15 healthy older persons will be observed, as well as 12-15 persons with cognitive&#xD;
      impairment, while playing Solitaire. This will take the shape of contextual inquiries, i.e.&#xD;
      the researcher visits the older person in his/her natural context and ask his/her to play&#xD;
      Solitaire. Older persons will be observed playing 8-10 rounds of playing Solitaire, both with&#xD;
      a physical deck of card and on a tablet. Gameplay actions and player behaviors will be&#xD;
      observed and recorded for later analysis, via screen capturing software installed on the&#xD;
      tablet, including the recordings of facial expressions and verbal utterances via the&#xD;
      integrated touchpad camera and microphone. According to the contextual inquiry method, which&#xD;
      is a 'light' form of participant observation, the researcher will take the role of an&#xD;
      'apprentice'; he/she will observe and may ask questions for a better understanding of the&#xD;
      player actions. At the end of the visit, following cognitive domains will be measured through&#xD;
      pen-and-paper testing: visual scanning and psychomotor speed (Digit symbol substitution&#xD;
      test), attention and executive function (Trail making test, digit span, verbal fluency, maze&#xD;
      test), Camden topographical memory,... The duration of such a visit will last approximately&#xD;
      120 minutes.&#xD;
&#xD;
      These observations of game play actions and behaviors and the results that participants&#xD;
      obtained on the cognitive test battery will be analyzed with experts in light of cognitive&#xD;
      performance. More particular, the investigator will look for the measurable aspects of&#xD;
      cognitive performance in the game, guided by earlier measures put forward by Jimison et al&#xD;
      and Kaye et al. While they still list generic measures (e.g. 'target detection' or 'correctly&#xD;
      retrieving item from previous knowledge'), this study will now operationalize these&#xD;
      specifically for the game of Solitaire and for the target group (e.g. 'detection of card to&#xD;
      move onto the build stack' or 'retrieving the card as available from the pile'). Hence,&#xD;
      possible game metrics will be discussed and defined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Specification of Cognitive Performance Metrics for the game Solitaire</measure>
    <time_frame>1 day</time_frame>
    <description>From this study, metrics will be defined which can measure cognitive performance in cardgames like Solitaire. Possible candidates are, but are not limited to: situational awareness to measure visual perception and performance on dual tasks to measure divided attention. A more detailed table of possible game metrics of cognitive performance can be found in H. B. Jimison, M. Pavel, P. Bissell, and J. McKanna, &quot;A Framework for Cognitive Monitoring Using Computer Game Interactions,&quot; Medinfo 2007 Proc. 12th World Congr. Health Med. Inform. Build. Sustain. Health Syst., p. 1073, 2007.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Design Guidelines Apps for the Elderly</measure>
    <time_frame>1 day</time_frame>
    <description>While playing the Solitaire game, feedback considering the usability of the game can be used to formulate design guidelines for applications.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>eHealth</condition>
  <arm_group>
    <arm_group_label>Healthy Elderly</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild Cognitive Impaired Elderly</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        24-30 participants, both cognitively healthy older persons (n = 12-15) as well as older&#xD;
        persons with mild cognitive impairment (MCI) or mild Alzheimer's disease (mAD) (12-15)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For the HEALTHY participants&#xD;
&#xD;
          1. The participant has a minimum age of 65 years.&#xD;
&#xD;
          2. The participant is living independently or semi-independently at home, service flat or&#xD;
             care home.&#xD;
&#xD;
          3. The participant has no subjective memory concern as reported by the participant,&#xD;
             informant, or clinician.&#xD;
&#xD;
          4. The participant has a normal brain function documented by scoring above 27 on the&#xD;
             MMSE, above 26 on the MOCA and has a score of 0 for the CDR.&#xD;
&#xD;
          5. In the opinion of the investigator, the participant is in stable medical condition and&#xD;
             willing and able to perform study procedures in the opinion of the investigator.&#xD;
&#xD;
          6. The participant is fluent in written and verbal Dutch.&#xD;
&#xD;
        For the participants with COGNITIVE IMPAIRMENT:&#xD;
&#xD;
          1. The participant has a minimum age of 65 years.&#xD;
&#xD;
          2. The participant is living independently or semi-independently at home, service flat or&#xD;
             care home.&#xD;
&#xD;
          3. In the opinion of the investigator, the participant is in stable medical condition and&#xD;
             willing and able to perform study procedures in the opinion of the investigator.&#xD;
&#xD;
          4. The participant is fluent in written and verbal Dutch.&#xD;
&#xD;
          5. For MCI: MCI patients, at baseline, are diagnosed applying Petersen's diagnostic&#xD;
             criteria, i.e., (1) cognitive complaint, preferably corroborated by an informant; (2)&#xD;
             objective cognitive impairment, quantified as performance of more than 1.5 SD below&#xD;
             the appropriate mean on the neuropsychological subtests (z-score below -1.5); (3)&#xD;
             largely normal general cognitive functioning; (4) essentially intact activities of&#xD;
             daily living (ADL) (basic and instrumental activities of daily living (iADL) were&#xD;
             determined by a clinical interview with the patient and an informant); and (5) not&#xD;
             demented.&#xD;
&#xD;
          6. For AD:Probable AD according to the National Institute on Aging/Alzheimer's&#xD;
             Association Diagnostic Guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vero Vanden Abeele, prof.</last_name>
    <role>Study Director</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karsten Gielis, Drs.</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jessa Hospital</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>January 19, 2021</last_update_submitted>
  <last_update_submitted_qc>January 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive Performance</keyword>
  <keyword>Meaningful Play</keyword>
  <keyword>Screening test</keyword>
  <keyword>Dementia</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02971124
org study id: S59650
nct id: NCT02971124
lead sponsor: 
collaborator: 
has dmc: No
To assess cognitive performance by means of the game of Solitaire. In this study, the
      investigators want to define relevant game metrics, when playing Solitaire, that may be
      indicative of cognitive performance.
12-15 healthy older persons will be observed, as well as 12-15 persons with cognitive
      impairment, while playing Solitaire. This will take the shape of contextual inquiries, i.e.
      the researcher visits the older person in his/her natural context and ask his/her to play
      Solitaire. Older persons will be observed playing 8-10 rounds of playing Solitaire, both with
      a physical deck of card and on a tablet. Gameplay actions and player behaviors will be
      observed and recorded for later analysis, via screen capturing software installed on the
      tablet, including the recordings of facial expressions and verbal utterances via the
      integrated touchpad camera and microphone. According to the contextual inquiry method, which
      is a 'light' form of participant observation, the researcher will take the role of an
      'apprentice'; he/she will observe and may ask questions for a better understanding of the
      player actions. At the end of the visit, following cognitive domains will be measured through
      pen-and-paper testing: visual scanning and psychomotor speed (Digit symbol substitution
      test), attention and executive function (Trail making test, digit span, verbal fluency, maze
      test), Camden topographical memory,... The duration of such a visit will last approximately
      120 minutes.

      These observations of game play actions and behaviors and the results that participants
      obtained on the cognitive test battery will be analyzed with experts in light of cognitive
      performance. More particular, the investigator will look for the measurable aspects of
      cognitive performance in the game, guided by earlier measures put forward by Jimison et al
      and Kaye et al. While they still list generic measures (e.g. 'target detection' or 'correctly
      retrieving item from previous knowledge'), this study will now operationalize these
      specifically for the game of Solitaire and for the target group (e.g. 'detection of card to
      move onto the build stack' or 'retrieving the card as available from the pile'). Hence,
      possible game metrics will be discussed and defined.
observational model: Case-Control
time perspective: Prospective
measure: Specification of Cognitive Performance Metrics for the game Solitaire
time frame: 1 day
description: From this study, metrics will be defined which can measure cognitive performance in cardgames like Solitaire. Possible candidates are, but are not limited to: situational awareness to measure visual perception and performance on dual tasks to measure divided attention. A more detailed table of possible game metrics of cognitive performance can be found in H. B. Jimison, M. Pavel, P. Bissell, and J. McKanna, "A Framework for Cognitive Monitoring Using Computer Game Interactions," Medinfo 2007 Proc. 12th World Congr. Health Med. Inform. Build. Sustain. Health Syst., p. 1073, 2007.
measure: Design Guidelines Apps for the Elderly
time frame: 1 day
description: While playing the Solitaire game, feedback considering the usability of the game can be used to formulate design guidelines for applications.
arm group label: Healthy Elderly
arm group label: Mild Cognitive Impaired Elderly
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vero Vanden Abeele, prof.
role: Study Director
affiliation: KU Leuven
last name: Karsten Gielis, Drs.
role: Principal Investigator
affiliation: KU Leuven
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: Undecided