<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/NCT04412083</url>
  </required_header>
  <id_info>
    <org_study_id>STU00210711</org_study_id>
    <nct_id>NCT04412083</nct_id>
  </id_info>
  <brief_title>PPA Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA</brief_title>
  <official_title>Primary Progressive Aphasia (PPA) Tele-Savvy: A Pilot Study of an Online Intervention for Caregivers of Persons Living With PPA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern 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 primary goal of this pilot project is to adapt an evidence-informed on-line&#xD;
      psychoeducation program (Tele-Savvy) to address the unique challenges facing informal&#xD;
      caregivers of those living with PPA and geared toward achieving caregiver mastery in this&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal of this pilot project is to develop an evidence-informed on-line&#xD;
      psychoeducation program (Tele-Savvy) based on the well-established Savvy Caregiver program to&#xD;
      address the unique challenges facing informal caregivers of those living with Primary&#xD;
      Progressive Aphasia (PPA) and to help these caregivers achieve mastery. Key elements of the&#xD;
      adaptation process are to identify and adapt mechanistic elements of the Tele-Savvy&#xD;
      intervention (increasing self-efficacy, mastery of new skills, increased knowledge of&#xD;
      disease-specific symptoms and trajectories, problem-solving skills). We will engage PPA&#xD;
      caregivers in the process of adapting the existing Tele-Savvy program to fit their needs and&#xD;
      then pilot test the adapted PPA Tele-Savvy program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2023</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Caregiver Mastery Pearlin Caregiver Stress Scale Score</measure>
    <time_frame>Baseline, 6-week follow-up</time_frame>
    <description>Comprised of 6 domains from the full Pearlin Stress Scale. 1. Relational Deprivation: 6-24, higher scores indicate increased relational deprivation. 2. Role Captivity: 3 - 12, higher scores indicate an increased feeling of being trapped in the caregiver role. 3. Loss of Self: 2 - 8, higher scores indicate a greater loss of self. 4. Caregiving competence: 4 - 16, higher scores indicate greater caregiving competence. 5. Management of Situation: 4 - 16, higher scores indicate better management of the caregiving situation. 6. Management of Meaning: 9 - 36, higher scores indicate a better management of the meaning of the caregiving role.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Caregiver Depression Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>Baseline, 6-week follow-up</time_frame>
    <description>A 20-item scale that represents a symptom cluster consisting of negative affect, positive affect, interpersonal problems, and somatic activity based on feelings over the past week.Scores range 0 - 60. A score of 0-16 indicates little to no symptomatology, a score of 16 or more indicates depression with higher scores indicating increased severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Caregiver Burden The Zarit Burden Interview score</measure>
    <time_frame>Baseline, 6-week follow-up</time_frame>
    <description>The interview was developed to measure subjective burden among caregivers of adults with dementia. The 22-item self-report inventory examines burden associated with functional/behavioral impairments and the home care situation. The items are worded subjectively, focusing on the affective response of the caregiver. Scores range 0 - 88. Lower scores indicate little to no burden. Higher scores indicate greater burden. A score of 17 or more is considered high burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Caregiver Stress Perceived Stress Survey score</measure>
    <time_frame>Baseline, 6-week follow-up</time_frame>
    <description>This questionnaire is comprised of 10 items from the Perceived Stress Scale. Scores range 0 - 40. Higher scores indicating higher perceived stress. A score of 0-13 would be considered low stress. Scores from 14-26 would be considered moderate stress. Scores from 27-40 indicate high perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Positive Aspects of Caregiving (PCOS) Scale score</measure>
    <time_frame>Baseline, 6-week follow-up</time_frame>
    <description>Caregivers will be instructed that &quot;In spite of all the difficulties involved in giving care to a family member with memory or health problems, good things can come out of caregiving experiences.&quot; The scale has 11 items, and overall scores range 0 - 44. Higher scores indicate a more positive view of the caregiving role while lower scores indicate less positive views of the caregiver role.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Care recipient quality of life DEMQOL: Dementia Quality of Life Measure (Carer v4) score</measure>
    <time_frame>Baseline, 6-week follow-up</time_frame>
    <description>This 32 item questionnaire will be used to assess mood, cognitive status, and overall quality of life of the care recipient. Scores range 31 - 124. Lower scores indicate no subjective concerns about cognition or general health, while higher scores indicate a greater subjective concern about cognition and general health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Behavioral and Psychological Symptoms of Dementia Revised Memory and Behavior Problem Checklist (RMBPC) score</measure>
    <time_frame>Baseline, 6-week follow-up</time_frame>
    <description>This 24 item instrument measures the frequency of the care recipient's problem behaviors in the following domains: disruptive behavior (wandering, aggression), memory-related behavior (repeating questions and stories), and depression. Scores range 0 - 96 for frequency. Lower scores indicate little to no behavioral problems while higher scores indicate greater behavioral issues. Scores range 0 - 96 for reaction. Lower scores indicate little concern regarding the behavior on the part of the caregiver while higher scores indicate greater concern.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Primary Progressive Aphasia</condition>
  <condition>Caregiver Burnout</condition>
  <arm_group>
    <arm_group_label>PPA Tele-Savvy Pilot Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Tele-Savvy program is comprised of weekly, two-hour interactive classes, over seven consecutive weeks, the same duration as the proposed intervention. Tele-Savvy consists of educational instruction, video and in-class exercises that engage participants on a functional level. Course material was designed to provide informal caregivers with the knowledge, skills, and attitude needed to carry out their role as a caregiver for a person living with dementia (PLWD). Course learning objectives include: 1) introduction to dementing disorder; 2) caregiver self-care; 3) the anchors of contented involvement; 4) levels of thinking and performance; 5) strengthening the family as a resource for caregiving; and 6) review and integration of the previous sections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PPA Tele-Savvy Pilot Intervention</intervention_name>
    <description>We will engage PPA caregivers in the process of adapting the existing Tele-Savvy program to fit their needs and then pilot test the adapted PPA Tele-Savvy program.</description>
    <arm_group_label>PPA Tele-Savvy Pilot Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Aim 1:&#xD;
&#xD;
        Informal (family or friends) caregivers of persons living with or deceased from PPA.&#xD;
&#xD;
        Age 18 or over Providing or have provided at least 2 hours per day of unpaid assistance, on&#xD;
        average, for a person in the early-middle stage of PPA.&#xD;
&#xD;
        Must have access to a computer with adequate internet connection. Able to use a&#xD;
        videoconferencing platform and receive email. Participants must be able to read, speak and&#xD;
        understand English and have no uncorrectable vision or hearing deficits that might impede&#xD;
        participation.&#xD;
&#xD;
        Aim 2:&#xD;
&#xD;
        Informal (family or friends) caregivers of persons living with PPA. Age 18 or over&#xD;
        Providing at least 2 hours per day of unpaid assistance, on average, for a person in the&#xD;
        early-middle stage of PPA.&#xD;
&#xD;
        Must have access to a computer with adequate internet connection. Able to use a&#xD;
        videoconferencing platform and receive email. Must be able to read, speak and understand&#xD;
        English and have no uncorrectable vision or hearing deficits that might impede&#xD;
        participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Darby Morhardt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Darby Morhardt, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Darby Morhardt, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Darby Morhardt, PhD</last_name>
    <phone>312-908-9432</phone>
    <email>d-morhardt@northwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lauren Dowden, MSW</last_name>
    <phone>312-503-5671</phone>
    <email>lauren.dowden@northwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mesulam Center for Cognitive Neurology and Alzheimer's Disease, Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Darby Morhardt, PhD</last_name>
      <phone>312-908-9432</phone>
      <email>d-morhardt@northwestern.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Darby Morhardt</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Frontotemporal Dementia</mesh_term>
    <mesh_term>Caregiver Burden</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/NCT04412083
org study id: STU00210711
nct id: NCT04412083
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary goal of this pilot project is to adapt an evidence-informed on-line
      psychoeducation program (Tele-Savvy) to address the unique challenges facing informal
      caregivers of those living with PPA and geared toward achieving caregiver mastery in this
      population.
The primary goal of this pilot project is to develop an evidence-informed on-line
      psychoeducation program (Tele-Savvy) based on the well-established Savvy Caregiver program to
      address the unique challenges facing informal caregivers of those living with Primary
      Progressive Aphasia (PPA) and to help these caregivers achieve mastery. Key elements of the
      adaptation process are to identify and adapt mechanistic elements of the Tele-Savvy
      intervention (increasing self-efficacy, mastery of new skills, increased knowledge of
      disease-specific symptoms and trajectories, problem-solving skills). We will engage PPA
      caregivers in the process of adapting the existing Tele-Savvy program to fit their needs and
      then pilot test the adapted PPA Tele-Savvy program.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Caregiver Mastery Pearlin Caregiver Stress Scale Score
time frame: Baseline, 6-week follow-up
description: Comprised of 6 domains from the full Pearlin Stress Scale. 1. Relational Deprivation: 6-24, higher scores indicate increased relational deprivation. 2. Role Captivity: 3 - 12, higher scores indicate an increased feeling of being trapped in the caregiver role. 3. Loss of Self: 2 - 8, higher scores indicate a greater loss of self. 4. Caregiving competence: 4 - 16, higher scores indicate greater caregiving competence. 5. Management of Situation: 4 - 16, higher scores indicate better management of the caregiving situation. 6. Management of Meaning: 9 - 36, higher scores indicate a better management of the meaning of the caregiving role.
measure: Change in Caregiver Depression Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: Baseline, 6-week follow-up
description: A 20-item scale that represents a symptom cluster consisting of negative affect, positive affect, interpersonal problems, and somatic activity based on feelings over the past week.Scores range 0 - 60. A score of 0-16 indicates little to no symptomatology, a score of 16 or more indicates depression with higher scores indicating increased severity.
measure: Change in Caregiver Burden The Zarit Burden Interview score
time frame: Baseline, 6-week follow-up
description: The interview was developed to measure subjective burden among caregivers of adults with dementia. The 22-item self-report inventory examines burden associated with functional/behavioral impairments and the home care situation. The items are worded subjectively, focusing on the affective response of the caregiver. Scores range 0 - 88. Lower scores indicate little to no burden. Higher scores indicate greater burden. A score of 17 or more is considered high burden.
measure: Change in Caregiver Stress Perceived Stress Survey score
time frame: Baseline, 6-week follow-up
description: This questionnaire is comprised of 10 items from the Perceived Stress Scale. Scores range 0 - 40. Higher scores indicating higher perceived stress. A score of 0-13 would be considered low stress. Scores from 14-26 would be considered moderate stress. Scores from 27-40 indicate high perceived stress.
measure: Change in Positive Aspects of Caregiving (PCOS) Scale score
time frame: Baseline, 6-week follow-up
description: Caregivers will be instructed that "In spite of all the difficulties involved in giving care to a family member with memory or health problems, good things can come out of caregiving experiences." The scale has 11 items, and overall scores range 0 - 44. Higher scores indicate a more positive view of the caregiving role while lower scores indicate less positive views of the caregiver role.
measure: Change in Care recipient quality of life DEMQOL: Dementia Quality of Life Measure (Carer v4) score
time frame: Baseline, 6-week follow-up
description: This 32 item questionnaire will be used to assess mood, cognitive status, and overall quality of life of the care recipient. Scores range 31 - 124. Lower scores indicate no subjective concerns about cognition or general health, while higher scores indicate a greater subjective concern about cognition and general health.
measure: Change in Behavioral and Psychological Symptoms of Dementia Revised Memory and Behavior Problem Checklist (RMBPC) score
time frame: Baseline, 6-week follow-up
description: This 24 item instrument measures the frequency of the care recipient's problem behaviors in the following domains: disruptive behavior (wandering, aggression), memory-related behavior (repeating questions and stories), and depression. Scores range 0 - 96 for frequency. Lower scores indicate little to no behavioral problems while higher scores indicate greater behavioral issues. Scores range 0 - 96 for reaction. Lower scores indicate little concern regarding the behavior on the part of the caregiver while higher scores indicate greater concern.
arm group label: PPA Tele-Savvy Pilot Intervention
arm group type: Other
description: The Tele-Savvy program is comprised of weekly, two-hour interactive classes, over seven consecutive weeks, the same duration as the proposed intervention. Tele-Savvy consists of educational instruction, video and in-class exercises that engage participants on a functional level. Course material was designed to provide informal caregivers with the knowledge, skills, and attitude needed to carry out their role as a caregiver for a person living with dementia (PLWD). Course learning objectives include: 1) introduction to dementing disorder; 2) caregiver self-care; 3) the anchors of contented involvement; 4) levels of thinking and performance; 5) strengthening the family as a resource for caregiving; and 6) review and integration of the previous sections.
intervention type: Behavioral
intervention name: PPA Tele-Savvy Pilot Intervention
description: We will engage PPA caregivers in the process of adapting the existing Tele-Savvy program to fit their needs and then pilot test the adapted PPA Tele-Savvy program.
arm group label: PPA Tele-Savvy Pilot Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Darby Morhardt, PhD
role: Principal Investigator
affiliation: Northwestern University
last name: Darby Morhardt, PhD
role: Study Chair
affiliation: Northwestern University
last name: Darby Morhardt, PhD
role: Study Director
affiliation: Northwestern University
last name: Darby Morhardt, PhD
phone: 312-908-9432
email: d-morhardt@northwestern.edu
last name: Lauren Dowden, MSW
phone: 312-503-5671
email: lauren.dowden@northwestern.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Darby Morhardt
investigator title: Associate Professor
mesh term: Aphasia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Frontotemporal Dementia
mesh term: Caregiver Burden
sharing ipd: No