<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/NCT03036423</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY0001991</org_study_id>
    <secondary_id>R01AG049764</secondary_id>
    <nct_id>NCT03036423</nct_id>
  </id_info>
  <brief_title>Cognitive Training for Older Caregivers</brief_title>
  <acronym>CTC</acronym>
  <official_title>Cognitive Training to Protect Immune Systems of Older Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test whether certain brain training activities can promote&#xD;
      cognitive, emotional, and physical health in caregivers of a loved one with dementia.&#xD;
      Numerous studies show that family dementia caregiving can be stressful, and can increase&#xD;
      mental and physical health risks. This study aims to understand how to reduce those risks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2016</start_date>
  <completion_date type="Actual">July 18, 2022</completion_date>
  <primary_completion_date type="Actual">July 18, 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Useful Field of View test performance at 12 months after the intervention</measure>
    <time_frame>12 months after the intervention</time_frame>
    <description>Useful Field of View computerized test of speed of processing and attention; lower score (in milliseconds) reflects better performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resting high frequency heart rate variability (HF-HRV) at 12 months after the intervention</measure>
    <time_frame>12 months after the intervention</time_frame>
    <description>HF-HRV is derived by spectral analysis of the electrocardiograph (ECG) waveform and is a measure of parasympathetic control of the heart; Higher resting HF-HRV (in Hz) reflects greater parasympathetic regulation of the heart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotion regulation at 12 months after the intervention</measure>
    <time_frame>12 months after the intervention</time_frame>
    <description>Measured as change in negative affect (from responses to the self-assessment manikin on a 9-point scale) from before to after a mental challenge; less increase in negative affect score suggests better emotion regulation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional well-being at 12 months after the intervention</measure>
    <time_frame>12 months after the intervention</time_frame>
    <description>The primary index of emotional well-being will be depressive symptoms (Center for Epidemiology Studies Depression scale); a lower score on this measure indicates less depressive symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immune aging</measure>
    <time_frame>12 months after the intervention</time_frame>
    <description>Identified from blood samples; lower levels of inflammation (measured by enzyme-linked immunosorbent assay (ELISA) assay) and T-lymphocyte profiles that reflect larger ratios of naïve T-cells relative to mature T-cells (measured from flow cytometry) will index less aging of the immune system</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">205</enrollment>
  <condition>Life Stress</condition>
  <arm_group>
    <arm_group_label>Online video education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will have computer access to a library of videos, including various lectures and demonstrations of interest, from which to select and view.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Computerized mental exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will use a computer to do a variety of activities which are customizable to their own abilities and progress.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online video education</intervention_name>
    <arm_group_label>Online video education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computerized mental exercises</intervention_name>
    <arm_group_label>Computerized mental exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking (consent process and assessments will be conducted in English only)&#xD;
&#xD;
          -  Currently living with or in proximity to, and the primary caregiver for a loved one&#xD;
             with dementia who lives in the community-for the purposes of this study, &quot;loved one&quot;&#xD;
             refers to a family member such as a spouse, ex-spouse, significant other, sibling,&#xD;
             in-law, parent, or other type of close established relationship (e.g., close friend)&#xD;
             regarded as family; &quot;primary caregivers&quot; provide daily informal (non-paid) in-person&#xD;
             care.&#xD;
&#xD;
          -  Currently experiencing moderate to high levels of perceived stress and caregiver&#xD;
             burden. Caregivers will be screened for stress levels and caregiving burden using the&#xD;
             10-item Perceived Stress Scale (PSS 10) and the Modified Caregiver Strain Index&#xD;
             (MCSI), respectively. Caregivers scoring above the population mean (approx.) on the&#xD;
             PSS 10 (&gt; 11), reporting at least moderate caregiver strain (score ≥ 5) on the MCSI&#xD;
             will be eligible for participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment or dementia (identified by the Montreal Cognitive Assessment&#xD;
             (MoCA)). Cutoff scores on the MoCA will be 23 or lower except for subjects who&#xD;
             identify as black or African American, in which case cutoffs will be based on scores&#xD;
             from the sample population reported in Rossetti et al (2017); subjects scoring greater&#xD;
             than one standard deviation below the published score, by respective age and&#xD;
             education, will be excluded.&#xD;
&#xD;
          -  current major depression (current Major Depression diagnosis and/or Geriatric&#xD;
             Depression Scale (GDS 15) score ≥ 10)&#xD;
&#xD;
          -  no recent (within 2 months) major surgery&#xD;
&#xD;
          -  History of events that cause neurological injury (e.g., stroke, transient ischemic&#xD;
             attack, traumatic brain injury or head injury with loss of consciousness)&#xD;
&#xD;
          -  Serious psychiatric or alcohol/substance use disorders, including current alcohol&#xD;
             dependence, current non-alcohol psychoactive substance use dependence, psychotic&#xD;
             disorders or features (current and lifetime), bipolar disorder (determined from Mini&#xD;
             International Neuropsychiatric Exam (MINI) modules)&#xD;
&#xD;
          -  Autoimmune disorder (e.g., Crohn's disease, lupus, rheumatoid arthritis)&#xD;
&#xD;
          -  Active neoplastic disease or receiving immunosuppressive therapy for cancer (or &lt; 6&#xD;
             months post-chemo or radiation) or other diseases (&lt; 3 months prior to enrollment)&#xD;
&#xD;
          -  No significant immunodeficiency disorder (e.g., alymphocytosis, hepatitis B or C, HIV)&#xD;
&#xD;
          -  Serious cardiovascular disease (e.g., congestive heart failure, pacemaker) or&#xD;
             myocardial infarction within past 6 months&#xD;
&#xD;
          -  Physical condition precluding required activities as part of the computerized&#xD;
             cognitive training (e.g., inability to use a computer mouse; inadequate visual acuity)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathi L Heffner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester Medical Center</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>November 2022</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Kathi Heffner</investigator_full_name>
    <investigator_title>Associate Professor of Nursing and Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03036423/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03036423
org study id: STUDY0001991
secondary id: R01AG049764
nct id: NCT03036423
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to test whether certain brain training activities can promote
      cognitive, emotional, and physical health in caregivers of a loved one with dementia.
      Numerous studies show that family dementia caregiving can be stressful, and can increase
      mental and physical health risks. This study aims to understand how to reduce those risks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Useful Field of View test performance at 12 months after the intervention
time frame: 12 months after the intervention
description: Useful Field of View computerized test of speed of processing and attention; lower score (in milliseconds) reflects better performance
measure: Resting high frequency heart rate variability (HF-HRV) at 12 months after the intervention
time frame: 12 months after the intervention
description: HF-HRV is derived by spectral analysis of the electrocardiograph (ECG) waveform and is a measure of parasympathetic control of the heart; Higher resting HF-HRV (in Hz) reflects greater parasympathetic regulation of the heart
measure: Emotion regulation at 12 months after the intervention
time frame: 12 months after the intervention
description: Measured as change in negative affect (from responses to the self-assessment manikin on a 9-point scale) from before to after a mental challenge; less increase in negative affect score suggests better emotion regulation
measure: Emotional well-being at 12 months after the intervention
time frame: 12 months after the intervention
description: The primary index of emotional well-being will be depressive symptoms (Center for Epidemiology Studies Depression scale); a lower score on this measure indicates less depressive symptoms
measure: Immune aging
time frame: 12 months after the intervention
description: Identified from blood samples; lower levels of inflammation (measured by enzyme-linked immunosorbent assay (ELISA) assay) and T-lymphocyte profiles that reflect larger ratios of naïve T-cells relative to mature T-cells (measured from flow cytometry) will index less aging of the immune system
arm group label: Online video education
arm group type: Active Comparator
description: Participants will have computer access to a library of videos, including various lectures and demonstrations of interest, from which to select and view.
arm group label: Computerized mental exercises
arm group type: Active Comparator
description: Participants will use a computer to do a variety of activities which are customizable to their own abilities and progress.
intervention type: Behavioral
intervention name: Online video education
arm group label: Online video education
intervention type: Behavioral
intervention name: Computerized mental exercises
arm group label: Computerized mental exercises
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathi L Heffner, PhD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Kathi Heffner
investigator title: Associate Professor of Nursing and Psychiatry
mesh term: Stress, Psychological
sharing ipd: No
provided document: 