<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/NCT04439500</url>
  </required_header>
  <id_info>
    <org_study_id>REB1738- sub-study</org_study_id>
    <nct_id>NCT04439500</nct_id>
  </id_info>
  <brief_title>Effects of Online Training Aimed at Increasing Participation in Everyday Life During a Pandemic (SCD Online).</brief_title>
  <official_title>Preventing Cognitive and Functional Decline Among Seniors at Risk-Effects of Online Training Aimed at Increasing Participation in Everyday Life During a Pandemic.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baycrest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baycrest</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a&#xD;
      psycho-education workshop for improving everyday life performance in older adults with&#xD;
      subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of&#xD;
      these approaches. Additionally, this study will provide insight into the benefits of the&#xD;
      program while people are not able to meet in person during a pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evidence suggests that 25-50% of community-dwelling older adults report SCD and that these&#xD;
      individuals have an elevated risk for developing Mild Cognitive Impairment and/or dementia.&#xD;
      Many of these individuals report difficulties with complex activities of daily living.&#xD;
&#xD;
      RWST aims to reduce these difficulties in everyday life by providing a meta-cognitive&#xD;
      training approach that compensates for age-related executive changes. The approach is&#xD;
      provided within the context of individually identified everyday-life difficulties.&#xD;
&#xD;
      The psycho-education approach is a Brain-Health Workshop supplemented by intellectually&#xD;
      stimulating activities such as doing Sudoku and/or word searches. This approach provides&#xD;
      information people may use to inform health behaviour changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention.</measure>
    <time_frame>Changes from baseline to post-intervention at 10 weeks</time_frame>
    <description>The COPM is a standardized semi-structure interview in which participants identify everyday life difficulties (defined as things they need to or want to do). These issues are converted to goals with performance rated on a 10-point Likert-type scale. Goals considered improved to criterion are those that have a 2 or more points increase on ratings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention.</measure>
    <time_frame>Three and six months post-intervention</time_frame>
    <description>Same as outcome 1. Goals considered improved to criterion are those that have a 2 or more points increase on ratings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved satisfaction with performance on trained and untrained goals identified using the COPM.</measure>
    <time_frame>10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention</time_frame>
    <description>Satisfaction with performance is measured on a 10-point Likert type scale using the Canadian Occupational Performance Measure. Goals considered improved to criterion are those that have a 2 or more points increase on ratings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Social Support Survey Instrument (MOS-SSS)</measure>
    <time_frame>Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention</time_frame>
    <description>This 5-point likert type instrument measures participants' perceived availability of social support in various situations. The lowest possible score is 20 and highest possible is 100. Higher scores indicate better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on DeJong Gierveld Loneliness Scale</measure>
    <time_frame>Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention</time_frame>
    <description>This scale measures loneliness and perceived social isolation. It will be administered to evaluate the impact of the intervention on participants' levels of self-isolation and loneliness. Lowest possible score is 0 and highest score is 6. Lower scores indicate better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on Lubben Social Network Scale</measure>
    <time_frame>Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention</time_frame>
    <description>This 5-point likert type scale measures social isolation by measuring frequency, size, and closeness of contacts of the respondent's social network by assessing the perceived level of support they get from friends and families. Lowest possible score is 0 and highest possible score is 30. Higher scores indicate better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health-related Quality of Life</measure>
    <time_frame>Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention</time_frame>
    <description>Health-related quality of life will be measured using the Short From Health Survey (SF-36). This survey includes the following sub scales (higher scores on each sub-scale indicate better outcome):&#xD;
Physical functioning with lowest possible score being 10 and highest 30; Role functioning with lowest possible score of 4 and highest 8; Bodily pain with lowest possible score of 2 and highest of 12; General health with lowest possible score of 5 and highest of 25; Vitality with lowest possible score of 4 and highest of 24; Social functioning with lowest possible score of 2 and highest of 10; Role-emotional with lowest possible score of 3 and highest of 6; Mental health with lowest possible score of 5 and highest of 30.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Subjective Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Real World Strategy Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group intervention including education and strategy training to manage everyday functional difficulties.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychosocial Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group sessions including education on brain health.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Real World Strategy Training</intervention_name>
    <description>The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.</description>
    <arm_group_label>Real World Strategy Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brain Education</intervention_name>
    <description>The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sodoku puzzles. Homework will consist of reading assignments related to the session topics.</description>
    <arm_group_label>Psychosocial Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have access to high speed internet and a computer or mobile device with a webcam&#xD;
&#xD;
          -  Have subjective cognitive complaints&#xD;
&#xD;
          -  Be fluent in written and spoken English&#xD;
&#xD;
          -  Able to self-identify areas of their everyday lives in which they would like to&#xD;
             improve.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of neurological conditions (e.g. dementia, mild cognitive impairment,&#xD;
             Parkinson's)&#xD;
&#xD;
          -  Presence of severe depression&#xD;
&#xD;
          -  Presence of substance abuse&#xD;
&#xD;
          -  History of hospitalization for psychiatric reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deirdre Dawson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rotman Research Institute, Baycrest Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baycrest Health Sciences</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6A 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baycrest</investigator_affiliation>
    <investigator_full_name>Dr. Deirdre Dawson</investigator_full_name>
    <investigator_title>Rotman Research Institute, Baycrest</investigator_title>
  </responsible_party>
  <keyword>Age-related cognitive changes</keyword>
  <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/NCT04439500
org study id: REB1738- sub-study
nct id: NCT04439500
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a
      psycho-education workshop for improving everyday life performance in older adults with
      subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of
      these approaches. Additionally, this study will provide insight into the benefits of the
      program while people are not able to meet in person during a pandemic.
Evidence suggests that 25-50% of community-dwelling older adults report SCD and that these
      individuals have an elevated risk for developing Mild Cognitive Impairment and/or dementia.
      Many of these individuals report difficulties with complex activities of daily living.

      RWST aims to reduce these difficulties in everyday life by providing a meta-cognitive
      training approach that compensates for age-related executive changes. The approach is
      provided within the context of individually identified everyday-life difficulties.

      The psycho-education approach is a Brain-Health Workshop supplemented by intellectually
      stimulating activities such as doing Sudoku and/or word searches. This approach provides
      information people may use to inform health behaviour changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention.
time frame: Changes from baseline to post-intervention at 10 weeks
description: The COPM is a standardized semi-structure interview in which participants identify everyday life difficulties (defined as things they need to or want to do). These issues are converted to goals with performance rated on a 10-point Likert-type scale. Goals considered improved to criterion are those that have a 2 or more points increase on ratings.
measure: Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention.
time frame: Three and six months post-intervention
description: Same as outcome 1. Goals considered improved to criterion are those that have a 2 or more points increase on ratings.
measure: Improved satisfaction with performance on trained and untrained goals identified using the COPM.
time frame: 10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention
description: Satisfaction with performance is measured on a 10-point Likert type scale using the Canadian Occupational Performance Measure. Goals considered improved to criterion are those that have a 2 or more points increase on ratings.
measure: Changes on Social Support Survey Instrument (MOS-SSS)
time frame: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention
description: This 5-point likert type instrument measures participants' perceived availability of social support in various situations. The lowest possible score is 20 and highest possible is 100. Higher scores indicate better outcome.
measure: Changes on DeJong Gierveld Loneliness Scale
time frame: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention
description: This scale measures loneliness and perceived social isolation. It will be administered to evaluate the impact of the intervention on participants' levels of self-isolation and loneliness. Lowest possible score is 0 and highest score is 6. Lower scores indicate better outcome.
measure: Changes on Lubben Social Network Scale
time frame: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention
description: This 5-point likert type scale measures social isolation by measuring frequency, size, and closeness of contacts of the respondent's social network by assessing the perceived level of support they get from friends and families. Lowest possible score is 0 and highest possible score is 30. Higher scores indicate better outcome.
measure: Change in health-related Quality of Life
time frame: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention
description: Health-related quality of life will be measured using the Short From Health Survey (SF-36). This survey includes the following sub scales (higher scores on each sub-scale indicate better outcome):
Physical functioning with lowest possible score being 10 and highest 30; Role functioning with lowest possible score of 4 and highest 8; Bodily pain with lowest possible score of 2 and highest of 12; General health with lowest possible score of 5 and highest of 25; Vitality with lowest possible score of 4 and highest of 24; Social functioning with lowest possible score of 2 and highest of 10; Role-emotional with lowest possible score of 3 and highest of 6; Mental health with lowest possible score of 5 and highest of 30.
arm group label: Real World Strategy Training
arm group type: Experimental
description: Group intervention including education and strategy training to manage everyday functional difficulties.
arm group label: Psychosocial Education
arm group type: Active Comparator
description: Group sessions including education on brain health.
intervention type: Behavioral
intervention name: Real World Strategy Training
description: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
arm group label: Real World Strategy Training
intervention type: Behavioral
intervention name: Brain Education
description: The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sodoku puzzles. Homework will consist of reading assignments related to the session topics.
arm group label: Psychosocial Education
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Deirdre Dawson, PhD
role: Principal Investigator
affiliation: Rotman Research Institute, Baycrest Health Sciences
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Baycrest
investigator full name: Dr. Deirdre Dawson
investigator title: Rotman Research Institute, Baycrest
mesh term: Cognitive Dysfunction