<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/NCT03292705</url>
  </required_header>
  <id_info>
    <org_study_id>R21AG054810</org_study_id>
    <nct_id>NCT03292705</nct_id>
  </id_info>
  <brief_title>Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment</brief_title>
  <acronym>CogT-PACT</acronym>
  <official_title>Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</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>
      Computerized cognitive interventions (CCIs) have been increasingly widely implemented among&#xD;
      older adults with mild cognitive impairment (MCI). However, the efficacy of CCIs in&#xD;
      maintaining or improving older adults' cognitive and functional health has been modest and&#xD;
      highly variable. Older individuals' attitudes toward technology use may help explain some of&#xD;
      the variability in CCI effects. The goal of this R21 is to generate proof-of-concept for an&#xD;
      intervention that may improve attitudes toward computers among those with MCI, in turn&#xD;
      improving engagement with and efficacy of a subsequent CCI. Person-centered care-that is,&#xD;
      integrating individuals' preferences throughout the process of intervention--has improved&#xD;
      intervention engagement among older persons, including those with MCI. A recent intervention&#xD;
      predicated on this person-centered approach is called &quot;personalized engagement program&quot;&#xD;
      (PEP). PEP involves a database of individualized computer-led leisure activities. The&#xD;
      investigators' recent pilot data in senior living facilities suggest that PEP promotes&#xD;
      psychological well-being among older persons with MCI, and may shift computers from&#xD;
      dauntingly complex or personally irrelevant devices to familiar, enjoyable technology. These&#xD;
      results are consistent with a number of theories indicating that exposure to pleasurable&#xD;
      experiences with an object or task improves several dimensions of attitudes, including&#xD;
      affective and cognitive components, as well as behavior and motivation. Grounded in both this&#xD;
      pilot data and the theory around it, the investigators seek to take the next step in an arc&#xD;
      of research ultimately intended to improve the efficacy of CCIs. A small randomized&#xD;
      controlled trial (RCT) is proposed to assess whether an initial period of PEP, followed by a&#xD;
      standard CCI, improves a) attitudes toward computers, b) engagement with the CCI, and c)&#xD;
      cognitive outcomes, compared to an attention control period followed by CCI. Our design&#xD;
      involving stratified random assignment of 50 assisted living residents with MCI from 4 senior&#xD;
      living facilities to these two groups. The initial phase involves 4 weeks of either attention&#xD;
      control or PEP, a &quot;dose&quot; suggested by prior work on attitude change and computers, followed&#xD;
      by 6 weeks of CCI for both groups (a period our prior work indicates is sufficient for change&#xD;
      in key cognitive domains among this population). This application is the first of which we&#xD;
      are aware striving to augment CCIs, which are now ubiquitous, by addressing an attitudinal or&#xD;
      affective element of the person, which are often ignored in the cognitive intervention&#xD;
      literature. The adjuvant of PEP also answers increasing calls for &quot;personalized&quot; or&#xD;
      &quot;person-centered&quot; behavioral interventions with older persons.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A single-blinded, multi-site (4 SLCs) randomized controlled trial of PEP+CCI, vs. control + CCI is involved. For PEP+CCI group, PEP will be implemented for the first 4 weeks, and CCI for the following 6 weeks. For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks. Assessments will be conducted by our research team. Separate staff blind to group assignment will conduct post-training and follow-up assessments. All intervention and assessments will occur in private rooms in relevant SLCs.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessor will be blinded to the group assignment. The participants will be informed to avoid discussing their intervention activities at the post-training and follow up assessments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Attitudes Toward Computers Questionnaire Total score</measure>
    <time_frame>Baseline, End of Weeks 4, End of Week 10, &amp; Week 23</time_frame>
    <description>change of attitudes towards technology across time points</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Useful Field of View</measure>
    <time_frame>Baseline, End of Week 10, &amp; Week 23</time_frame>
    <description>change of visual speed of processing and attention across time points</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Executive Function</measure>
    <time_frame>Baseline, End of Weeks 4, End of Week 10, &amp; Week 23</time_frame>
    <description>change of executive function across time points</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Visuospatial Memory Test</measure>
    <time_frame>Baseline, End of Weeks 4, End of Week 10, &amp; Week 23</time_frame>
    <description>change of visuospatial memory across time points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activities of Daily Living-Prevention Instrument</measure>
    <time_frame>Baseline, End of Weeks 4, End of Week 10, &amp; Week 23</time_frame>
    <description>change of self-perceived functioning in daily living activities across time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Everyday Problems for Cognitive Challenged Elderly Test</measure>
    <time_frame>Baseline, End of Weeks 4, End of Week 10, &amp; Week 23</time_frame>
    <description>change of objective functioning in daily living activities across time points</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>PEP+CCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.&#xD;
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.&#xD;
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control+CCI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PEP</intervention_name>
    <description>The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains. For instance, if music is among a person's lifelong interests, the system provides access to multiple music genres through jukebox, karaoke and therapeutic music applications that can be tailored to a particular activity and by individual interest (for instance, a preference for classic jazz). As another example, for someone who likes travel or visiting new places, the interface offers access to Google Earth, guided tours, slide shows and regional facts and history.</description>
    <arm_group_label>PEP+CCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CCI</intervention_name>
    <description>VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.</description>
    <arm_group_label>PEP+CCI</arm_group_label>
    <arm_group_label>control+CCI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 ≤ MoCA ≤ 26&#xD;
&#xD;
          -  RAVLT Delayed Recall Total Score ≤ 6 (or 1.5 SD below age-corrected norms)&#xD;
&#xD;
          -  mild or no active depressive symptoms&#xD;
&#xD;
          -  intact or mild deficits in IADL functioning&#xD;
&#xD;
          -  if on AD medication (i.e., Memantine or cholinesterase inhibitors), antidepressant, or&#xD;
             anxiolytics, no changes of doses in the 3 months prior to recruitment;&#xD;
&#xD;
          -  age ≥60 years&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  adequate visual and hearing acuity for testing&#xD;
&#xD;
          -  intact decision making capacity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current enrollment in another cognitive improvement study;&#xD;
&#xD;
          -  uncontrollable major depression: or other psychopathology identified by staff or&#xD;
             medical records;&#xD;
&#xD;
          -  having active legal guardian (indicating impaired capacity for decision making);&#xD;
&#xD;
          -  medical history of AD or other types of dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Corriveau, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brickstone/Saint John Meadow</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>River Edge Manor</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>December 5, 2019</last_update_submitted>
  <last_update_submitted_qc>December 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Vankee Lin</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>cognitive training</keyword>
  <keyword>person-centered approach</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <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/NCT03292705
org study id: R21AG054810
nct id: NCT03292705
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Computerized cognitive interventions (CCIs) have been increasingly widely implemented among
      older adults with mild cognitive impairment (MCI). However, the efficacy of CCIs in
      maintaining or improving older adults' cognitive and functional health has been modest and
      highly variable. Older individuals' attitudes toward technology use may help explain some of
      the variability in CCI effects. The goal of this R21 is to generate proof-of-concept for an
      intervention that may improve attitudes toward computers among those with MCI, in turn
      improving engagement with and efficacy of a subsequent CCI. Person-centered care-that is,
      integrating individuals' preferences throughout the process of intervention--has improved
      intervention engagement among older persons, including those with MCI. A recent intervention
      predicated on this person-centered approach is called "personalized engagement program"
      (PEP). PEP involves a database of individualized computer-led leisure activities. The
      investigators' recent pilot data in senior living facilities suggest that PEP promotes
      psychological well-being among older persons with MCI, and may shift computers from
      dauntingly complex or personally irrelevant devices to familiar, enjoyable technology. These
      results are consistent with a number of theories indicating that exposure to pleasurable
      experiences with an object or task improves several dimensions of attitudes, including
      affective and cognitive components, as well as behavior and motivation. Grounded in both this
      pilot data and the theory around it, the investigators seek to take the next step in an arc
      of research ultimately intended to improve the efficacy of CCIs. A small randomized
      controlled trial (RCT) is proposed to assess whether an initial period of PEP, followed by a
      standard CCI, improves a) attitudes toward computers, b) engagement with the CCI, and c)
      cognitive outcomes, compared to an attention control period followed by CCI. Our design
      involving stratified random assignment of 50 assisted living residents with MCI from 4 senior
      living facilities to these two groups. The initial phase involves 4 weeks of either attention
      control or PEP, a "dose" suggested by prior work on attitude change and computers, followed
      by 6 weeks of CCI for both groups (a period our prior work indicates is sufficient for change
      in key cognitive domains among this population). This application is the first of which we
      are aware striving to augment CCIs, which are now ubiquitous, by addressing an attitudinal or
      affective element of the person, which are often ignored in the cognitive intervention
      literature. The adjuvant of PEP also answers increasing calls for "personalized" or
      "person-centered" behavioral interventions with older persons.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A single-blinded, multi-site (4 SLCs) randomized controlled trial of PEP+CCI, vs. control + CCI is involved. For PEP+CCI group, PEP will be implemented for the first 4 weeks, and CCI for the following 6 weeks. For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks. Assessments will be conducted by our research team. Separate staff blind to group assignment will conduct post-training and follow-up assessments. All intervention and assessments will occur in private rooms in relevant SLCs.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Outcome assessor will be blinded to the group assignment. The participants will be informed to avoid discussing their intervention activities at the post-training and follow up assessments.
measure: Attitudes Toward Computers Questionnaire Total score
time frame: Baseline, End of Weeks 4, End of Week 10, & Week 23
description: change of attitudes towards technology across time points
measure: Useful Field of View
time frame: Baseline, End of Week 10, & Week 23
description: change of visual speed of processing and attention across time points
measure: Executive Function
time frame: Baseline, End of Weeks 4, End of Week 10, & Week 23
description: change of executive function across time points
measure: Brief Visuospatial Memory Test
time frame: Baseline, End of Weeks 4, End of Week 10, & Week 23
description: change of visuospatial memory across time points
measure: Activities of Daily Living-Prevention Instrument
time frame: Baseline, End of Weeks 4, End of Week 10, & Week 23
description: change of self-perceived functioning in daily living activities across time points
measure: Everyday Problems for Cognitive Challenged Elderly Test
time frame: Baseline, End of Weeks 4, End of Week 10, & Week 23
description: change of objective functioning in daily living activities across time points
arm group label: PEP+CCI
arm group type: Experimental
description: PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains.
CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention.
Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks.
arm group label: control+CCI
arm group type: Active Comparator
description: For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks.
intervention type: Behavioral
intervention name: PEP
description: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains. For instance, if music is among a person's lifelong interests, the system provides access to multiple music genres through jukebox, karaoke and therapeutic music applications that can be tailored to a particular activity and by individual interest (for instance, a preference for classic jazz). As another example, for someone who likes travel or visiting new places, the interface offers access to Google Earth, guided tours, slide shows and regional facts and history.
arm group label: PEP+CCI
intervention type: Behavioral
intervention name: CCI
description: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
arm group label: PEP+CCI
arm group label: control+CCI
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anne Corriveau, PhD
role: Study Director
affiliation: University of Rochester
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Vankee Lin
investigator title: Assistant Professor
mesh term: Cognitive Dysfunction
sharing ipd: Undecided