<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/NCT03262506</url>
  </required_header>
  <id_info>
    <org_study_id>ASASTEL study</org_study_id>
    <nct_id>NCT03262506</nct_id>
  </id_info>
  <brief_title>Evaluation of Adherence and Engagement in a Cognitive Training Program for Older Adults</brief_title>
  <official_title>Evaluation of Adherence and Engagement in a Cognitive Training Program for Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio de Janeiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio de Janeiro</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>
      There is evidence that computerized cognitive training can improve cognition in healthy older&#xD;
      adults and in people at risk of developing dementia, although an effective model to implement&#xD;
      the training in the daily life of people and to ensure engagement is missing. This project&#xD;
      studies the adherence, engagement and progress on computerized cognitive training exercises&#xD;
      that were offered by the Association of Retirees from the Telecommunications (ASASTEL) to its&#xD;
      associates. One hundred subjects in three different cities (Rio de Janeiro, Belo Horizonte&#xD;
      and Brasilia) received licenses to perform the exercises on line and were followed by a team&#xD;
      of psychologists. We will evaluate adherence, engagement and progress on the computerized&#xD;
      cognitive training exercises of those subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 7, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2017</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Training adherence</measure>
    <time_frame>1 year</time_frame>
    <description>Training adherence will be defined as a continuous variable (number of hours of training completed by the participant).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Individual gains on the computerized exercises</measure>
    <time_frame>1 year</time_frame>
    <description>The computerized cognitive training platform, called BrainHQ, provided by Posit Science Inc, provides the individual gains on the computerized exercises with training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation with the computerized training exercise</measure>
    <time_frame>1 year</time_frame>
    <description>Motivation will be assessed by quantitative (measured as a percentage of all stimulus sets available in the exercises of the BrainHq computerized cognitive training platform) and qualitative questionnaires (Adapted Ultrech Engagement Scale - UWES).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Training adherence (dichotomic variable)</measure>
    <time_frame>1 year</time_frame>
    <description>Additionally training adherence will be defined as a dichotomic variable (below or above 10 hours of training).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Cognitive Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computerized cognitive training</intervention_name>
    <description>The cognitive training program consists of a set of computerized exercises designed to improve the speed and accuracy of auditory information processing while engaging neuromodulatory systems involved in attention and reward. These exercises continuously adjust the difficulty level to user performance to maintain an approximately 85% rate of correct responses. Trials with correct responses are rewarded with points and animations.</description>
    <arm_group_label>Cognitive Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be an associate of ASASTEL, or the spouse of an associate,&#xD;
&#xD;
          -  To have access to the internet at home and proficiency on accessing and navigating the&#xD;
             internet,&#xD;
&#xD;
          -  Availability to be evaluated and followed by the professional team.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical condition that precludes performing the computerized training exercises,&#xD;
&#xD;
          -  Score below 27 points in the Mini Mental State Examination (MEEM),&#xD;
&#xD;
          -  Moderated or advanced dementia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidade Federal do Rio de Janeiro</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rogério Panizzutti, MD, Phd</last_name>
      <phone>5521999090498</phone>
      <email>rogerio@icb.ufrj.br</email>
    </contact>
    <contact_backup>
      <last_name>Aline D'Avila, MSc</last_name>
      <phone>5531987778981</phone>
      <email>lininha_davila@yahoo.com.br</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio de Janeiro</investigator_affiliation>
    <investigator_full_name>Rogerio Panizzutti</investigator_full_name>
    <investigator_title>Chief Investigator</investigator_title>
  </responsible_party>
  <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/NCT03262506
org study id: ASASTEL study
nct id: NCT03262506
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is evidence that computerized cognitive training can improve cognition in healthy older
      adults and in people at risk of developing dementia, although an effective model to implement
      the training in the daily life of people and to ensure engagement is missing. This project
      studies the adherence, engagement and progress on computerized cognitive training exercises
      that were offered by the Association of Retirees from the Telecommunications (ASASTEL) to its
      associates. One hundred subjects in three different cities (Rio de Janeiro, Belo Horizonte
      and Brasilia) received licenses to perform the exercises on line and were followed by a team
      of psychologists. We will evaluate adherence, engagement and progress on the computerized
      cognitive training exercises of those subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Training adherence
time frame: 1 year
description: Training adherence will be defined as a continuous variable (number of hours of training completed by the participant).
measure: Individual gains on the computerized exercises
time frame: 1 year
description: The computerized cognitive training platform, called BrainHQ, provided by Posit Science Inc, provides the individual gains on the computerized exercises with training.
measure: Motivation with the computerized training exercise
time frame: 1 year
description: Motivation will be assessed by quantitative (measured as a percentage of all stimulus sets available in the exercises of the BrainHq computerized cognitive training platform) and qualitative questionnaires (Adapted Ultrech Engagement Scale - UWES).
measure: Training adherence (dichotomic variable)
time frame: 1 year
description: Additionally training adherence will be defined as a dichotomic variable (below or above 10 hours of training).
arm group label: Cognitive Training
arm group type: Experimental
intervention type: Other
intervention name: Computerized cognitive training
description: The cognitive training program consists of a set of computerized exercises designed to improve the speed and accuracy of auditory information processing while engaging neuromodulatory systems involved in attention and reward. These exercises continuously adjust the difficulty level to user performance to maintain an approximately 85% rate of correct responses. Trials with correct responses are rewarded with points and animations.
arm group label: Cognitive Training
criteria: 
gender: All
minimum age: 60 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio de Janeiro
investigator full name: Rogerio Panizzutti
investigator title: Chief Investigator
sharing ipd: No