<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/NCT04480112</url>
  </required_header>
  <id_info>
    <org_study_id>H-26786</org_study_id>
    <nct_id>NCT04480112</nct_id>
  </id_info>
  <brief_title>Impact of Covid-19 on Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults</brief_title>
  <official_title>Impact of Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults With and Without Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University</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 current study will examine the impact of frequent social interaction through&#xD;
      communication technologies during COVID-19 pandemic in the cognitive status of&#xD;
      socially-isolated older adults with and without cognitive impairment. Patients will take&#xD;
      place in an experimental crossover study, participants will complete one month of an&#xD;
      intervention and one month of as passive control. The goal of this study is to determine: A.)&#xD;
      if frequent social interaction through ICT during COVID-19 pandemic will have a significant&#xD;
      positive impact in cognitive performance on testing, and B.) how social isolation and&#xD;
      cognitive status influence misconceptions around the current pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study will examine the impact of frequent social interaction through&#xD;
      communication technologies during COVID-19 pandemic in the cognitive status of&#xD;
      socially-isolated older adults with and without cognitive impairment. An estimated 150 total&#xD;
      participants will be recruited over the course of 1 year: 50 healthy older participants, 50&#xD;
      patients with amnestic mild cognitive impairment, and 50 patients with mild AD.&#xD;
&#xD;
      This study employs an AB/BA crossover design (2-sequence, 2-period, 2-treatment design) where&#xD;
      A will be the intervention phase and B will be the passive control phase. Each period will&#xD;
      occur over a duration of 1 month. Participants will either receive an intervention designed&#xD;
      to provide participants with more social interaction during a time of social distancing and&#xD;
      highly limited in-person social interactions (Intervention Group) or will not receive the&#xD;
      intervention (Control Group). The investigators will conduct pre- and post-&#xD;
      neuropsychological testing to assess changes in cognitive status (e.g., memory, language,&#xD;
      executive functioning) in the intervention group after each intervention phase.&#xD;
      Neuropsychological tests assessing changes to cognition will be completed prior to&#xD;
      participant assignment to the Intervention or Control Group. Following this assessment, the&#xD;
      first phase of the intervention will begin, and the initial intervention group (Group A) will&#xD;
      receive the intervention, and the other group (Group B) will act as a control group. After&#xD;
      the intervention phase has ended, both groups will be assessed again using neuropsychological&#xD;
      tests. Following the re-assessment, Group B will receive the intervention, and Group A will&#xD;
      act as a control. After the second intervention phase has ended, both groups will be assessed&#xD;
      once more using neuropsychological tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Actual">June 11, 2021</completion_date>
  <primary_completion_date type="Actual">June 11, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>The investigators will employ an AB/BA crossover design (2-sequence, 2-period, 2-treatment design) where A will be the intervention phase and B will be the passive control phase. Each period will have a duration of 1 month. Assessment of the primary outcome will be done at the end of each period. Since this is a study of a behavioral intervention, 4-week washout period will suffice to observe an acute change in cognitive performance without significant carryover effects.&#xD;
To avoid imbalance among groups, randomization will be stratified by cognitive syndrome diagnosis (healthy older adult, mild cognitive impairment and mild dementia). Participants will be randomized to the treatment sequences using a 1:1 allocation ratio.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Trial investigators and outcome assessors will be blind to the treatment randomization and allocation..</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in memory performance</measure>
    <time_frame>Baseline,1 month</time_frame>
    <description>The Oral Trail Making Test B (TMT-B) will be used to assess memory performance. It is a neuropsychological measure that provides an assessment of sequential set-shifting. Participants are asked to count from 1 to 25 switching between number and letter, eg 1-A-2-B-3-C, until stopped.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cognition</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS) will be administered to assess cognitive decline or improvement. The 12 items on the RBANS assess five cognitive domains: immediate memory, visuospatial/constructional abilities, language, attention, and delayed memory. Scores can range from 0-160 and are interpreted as: 130 and above- very superior; 120-129 - superior; 110-119- high average; 90-109- average; 80-89- low average; 70-79- borderline; 60 and below extremely low.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in phonemic fluency</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>Phonemic fluency will be assessed by asking participants to produce orally as many words as possible beginning with a specific letter or for a specific category (eg animals, fruits, etc). The test consists of three trials, of 1 min each. The higher the number of words provided, the greater the verbal fluency.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Social isolation</measure>
    <time_frame>1 month</time_frame>
    <description>The 6-item version of the Lubben Social Network scale (LSNS-6) will be used to assess social isolation. For each of the 6 questions the participant rates from 0 to 5 their perceived social engagement where 0=less social engagement and 5= more social engagement. The summed total score ranges between 0 and 30. Lower total scores indicate more social isolation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loneliness</measure>
    <time_frame>1 month</time_frame>
    <description>Loneliness will be assessed using the UCLA loneliness scale. Participants rate each item as either O (&quot;I often feel this way&quot;= 3),S (&quot;I sometimes feel this way&quot;=2), R (&quot;I rarely feel this way&quot;=1), N (&quot;I never feel this way&quot;=0). A total score is computed by adding up the response to each question and can range from 0 to 60. The average loneliness score on the measure is 20. A score of 25 or higher reflects a high level of loneliness. A score of 30 or higher reflects a very high level of loneliness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>1 month</time_frame>
    <description>The Geriatric Depression Scale (GDS) will be used to assess depression. It consists of 15 questions- 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Misinformation about Covid-19</measure>
    <time_frame>1 month</time_frame>
    <description>An investigator developed questionnaire based on survey results published by Geldsetzer P in Annals of Internal Medicine, 3-2020 will be used to assess Covid-19 misinformation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">196</enrollment>
  <condition>Memory Disorders</condition>
  <condition>Alzheimer Disease</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Group A Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Group A will receive an intervention designed to provide participants with more social interaction during a time of social distancing and highly limited in-person social interactions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in Group B will not receive any new interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Technology based social interactions</intervention_name>
    <description>Participants will be socially interacting using any available technology with members of the research team.</description>
    <arm_group_label>Group A Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No research related technology based social interactions</intervention_name>
    <description>No technology based social interactions with the research team.</description>
    <arm_group_label>Group B Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recent diagnosis from the Boston University Alzheimer's Disease Center of mild AD&#xD;
             (with a recent Mini Mental State Examination score greater than 20)&#xD;
&#xD;
          -  Meet criteria for social isolation- a state in which an individual has a minimal&#xD;
             number of social contacts and lacks engagement with others either physically or&#xD;
             remotely through communication technology.&#xD;
&#xD;
          -  English as their primary language&#xD;
&#xD;
          -  Have access to either a computer, smart device, or telephone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant depression&#xD;
&#xD;
          -  Alcohol or drug use&#xD;
&#xD;
          -  Cerebrovascular disease, traumatic brain damage, other degenerative disease (e.g.,&#xD;
             Parkinson's disease)&#xD;
&#xD;
          -  Do not have corrected vision of 20/30 or better&#xD;
&#xD;
          -  perform below 80% correct on the speech discrimination test from the Boston Diagnostic&#xD;
             Aphasia Examination&#xD;
&#xD;
          -  Score below 27 on the Mini-Mental State Examination (MMSE)&#xD;
&#xD;
          -  Score below two standard deviations on any element of the Consortium to Establish a&#xD;
             Registry for Alzheimer's Disease (CERAD) Word List Memory test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew E Busdon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Neurology at BU School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston University Alzheimer Disease Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>August 27, 2021</last_update_submitted>
  <last_update_submitted_qc>August 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Social Isolation</keyword>
  <keyword>Cognition</keyword>
  <keyword>Misinformation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Memory Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT04480112
org study id: H-26786
nct id: NCT04480112
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study will examine the impact of frequent social interaction through
      communication technologies during COVID-19 pandemic in the cognitive status of
      socially-isolated older adults with and without cognitive impairment. Patients will take
      place in an experimental crossover study, participants will complete one month of an
      intervention and one month of as passive control. The goal of this study is to determine: A.)
      if frequent social interaction through ICT during COVID-19 pandemic will have a significant
      positive impact in cognitive performance on testing, and B.) how social isolation and
      cognitive status influence misconceptions around the current pandemic.
The current study will examine the impact of frequent social interaction through
      communication technologies during COVID-19 pandemic in the cognitive status of
      socially-isolated older adults with and without cognitive impairment. An estimated 150 total
      participants will be recruited over the course of 1 year: 50 healthy older participants, 50
      patients with amnestic mild cognitive impairment, and 50 patients with mild AD.

      This study employs an AB/BA crossover design (2-sequence, 2-period, 2-treatment design) where
      A will be the intervention phase and B will be the passive control phase. Each period will
      occur over a duration of 1 month. Participants will either receive an intervention designed
      to provide participants with more social interaction during a time of social distancing and
      highly limited in-person social interactions (Intervention Group) or will not receive the
      intervention (Control Group). The investigators will conduct pre- and post-
      neuropsychological testing to assess changes in cognitive status (e.g., memory, language,
      executive functioning) in the intervention group after each intervention phase.
      Neuropsychological tests assessing changes to cognition will be completed prior to
      participant assignment to the Intervention or Control Group. Following this assessment, the
      first phase of the intervention will begin, and the initial intervention group (Group A) will
      receive the intervention, and the other group (Group B) will act as a control group. After
      the intervention phase has ended, both groups will be assessed again using neuropsychological
      tests. Following the re-assessment, Group B will receive the intervention, and Group A will
      act as a control. After the second intervention phase has ended, both groups will be assessed
      once more using neuropsychological tests.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: The investigators will employ an AB/BA crossover design (2-sequence, 2-period, 2-treatment design) where A will be the intervention phase and B will be the passive control phase. Each period will have a duration of 1 month. Assessment of the primary outcome will be done at the end of each period. Since this is a study of a behavioral intervention, 4-week washout period will suffice to observe an acute change in cognitive performance without significant carryover effects.
To avoid imbalance among groups, randomization will be stratified by cognitive syndrome diagnosis (healthy older adult, mild cognitive impairment and mild dementia). Participants will be randomized to the treatment sequences using a 1:1 allocation ratio.
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Trial investigators and outcome assessors will be blind to the treatment randomization and allocation..
measure: Change in memory performance
time frame: Baseline,1 month
description: The Oral Trail Making Test B (TMT-B) will be used to assess memory performance. It is a neuropsychological measure that provides an assessment of sequential set-shifting. Participants are asked to count from 1 to 25 switching between number and letter, eg 1-A-2-B-3-C, until stopped.
measure: Change in cognition
time frame: Baseline, 1 month
description: Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS) will be administered to assess cognitive decline or improvement. The 12 items on the RBANS assess five cognitive domains: immediate memory, visuospatial/constructional abilities, language, attention, and delayed memory. Scores can range from 0-160 and are interpreted as: 130 and above- very superior; 120-129 - superior; 110-119- high average; 90-109- average; 80-89- low average; 70-79- borderline; 60 and below extremely low.
measure: Change in phonemic fluency
time frame: Baseline, 1 month
description: Phonemic fluency will be assessed by asking participants to produce orally as many words as possible beginning with a specific letter or for a specific category (eg animals, fruits, etc). The test consists of three trials, of 1 min each. The higher the number of words provided, the greater the verbal fluency.
measure: Social isolation
time frame: 1 month
description: The 6-item version of the Lubben Social Network scale (LSNS-6) will be used to assess social isolation. For each of the 6 questions the participant rates from 0 to 5 their perceived social engagement where 0=less social engagement and 5= more social engagement. The summed total score ranges between 0 and 30. Lower total scores indicate more social isolation.
measure: Loneliness
time frame: 1 month
description: Loneliness will be assessed using the UCLA loneliness scale. Participants rate each item as either O ("I often feel this way"= 3),S ("I sometimes feel this way"=2), R ("I rarely feel this way"=1), N ("I never feel this way"=0). A total score is computed by adding up the response to each question and can range from 0 to 60. The average loneliness score on the measure is 20. A score of 25 or higher reflects a high level of loneliness. A score of 30 or higher reflects a very high level of loneliness.
measure: Depressive symptoms
time frame: 1 month
description: The Geriatric Depression Scale (GDS) will be used to assess depression. It consists of 15 questions- 10 indicate the presence of depression when answered positively, while the rest (question numbers 1, 5, 7, 11, 13) indicate depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
measure: Misinformation about Covid-19
time frame: 1 month
description: An investigator developed questionnaire based on survey results published by Geldsetzer P in Annals of Internal Medicine, 3-2020 will be used to assess Covid-19 misinformation.
arm group label: Group A Intervention
arm group type: Experimental
description: Participants in Group A will receive an intervention designed to provide participants with more social interaction during a time of social distancing and highly limited in-person social interactions
arm group label: Group B Control
arm group type: Active Comparator
description: Participants in Group B will not receive any new interventions.
intervention type: Behavioral
intervention name: Technology based social interactions
description: Participants will be socially interacting using any available technology with members of the research team.
arm group label: Group A Intervention
intervention type: Other
intervention name: No research related technology based social interactions
description: No technology based social interactions with the research team.
arm group label: Group B Control
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Andrew E Busdon, MD
role: Principal Investigator
affiliation: Professor of Neurology at BU School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Memory Disorders
mesh term: Cognitive Dysfunction
sharing ipd: No