<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/NCT04421729</url>
  </required_header>
  <id_info>
    <org_study_id>5356000538</org_study_id>
    <nct_id>NCT04421729</nct_id>
  </id_info>
  <brief_title>SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in Southern California</brief_title>
  <acronym>SoCalSavvy</acronym>
  <official_title>SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</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 investigators will conduct a hybrid efficacy-effectiveness trial intended to address&#xD;
      these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and&#xD;
      on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los&#xD;
      Angeles County for feasibility) and Savvy Caregiver Program (original 6-session&#xD;
      evidenced-based intervention), across post-intervention, 3- and 6-months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A number of epidemiological studies, systematic reviews, and consensus reports highlight the&#xD;
      importance of non-pharmacological, sociobehavioural interventions to address the health,&#xD;
      psychological, and social effects of caregiving for persons living with dementia, and the&#xD;
      need for tangible information and resources.&#xD;
&#xD;
      The investigators will conduct a hybrid efficacy-effectiveness trial intended to address&#xD;
      these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and&#xD;
      on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los&#xD;
      Angeles County for feasibility) and Savvy Caregiver Program (original 6-session&#xD;
      evidenced-based intervention), across post-intervention, 3- and 6-months. It is hypothesized&#xD;
      that no differences (comparable effects) between the programs in their efficacy/effectiveness&#xD;
      and moderating conditions.&#xD;
&#xD;
      Focus groups (~25 participants) will be conducted to ascertain program acceptability and&#xD;
      satisfaction.&#xD;
&#xD;
      The analyses will include a multiple linear mixed-effects modeling for our trial outcomes,&#xD;
      and thematic analyses for our focus group interview data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The outcome assessor will not have previous knowledge of the respondent's interventional group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>up to 7 months</time_frame>
    <description>caregiver depressive symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder (GAD-7)</measure>
    <time_frame>up to 7 months</time_frame>
    <description>caregiver anxiety symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Revised Memory and Behavior Problems Checklist (RMBPC)</measure>
    <time_frame>up to 7 months</time_frame>
    <description>caregiver reactivity to family member's memory/behavior problems</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caregiver Competence Scales</measure>
    <time_frame>up to 7 months</time_frame>
    <description>measures caregiver skills, mastery, competence, management of the situation based on the Caregiver Competence, Management and Meaning Scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study Social Support Survey (MOS)</measure>
    <time_frame>up to 7 months</time_frame>
    <description>Measures caregiver social support using the MOS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intent to Institutionalize</measure>
    <time_frame>up to 7 months</time_frame>
    <description>TA one-item measure that assesses if the caregiver intends to institutionalize the family member in the next 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Members Activities of Daily Living (ADL)</measure>
    <time_frame>up to 7 months</time_frame>
    <description>measures family member's activities of daily living using the Katz ADL scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Members Instrumental Activities of Daily Living (IADL)</measure>
    <time_frame>up to 7 months</time_frame>
    <description>measures family member's activities of daily living using the Lawton IDL scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Caregiver Satisfaction</measure>
    <time_frame>up to 7 months</time_frame>
    <description>This is a measure developed for this specific study to ascertain the study participant's satisfaction with the intervention itself.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Caregiver Burnout</condition>
  <condition>Psychological Distress</condition>
  <arm_group>
    <arm_group_label>Savvy Caregiver Program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Savvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Savvy Express</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Savvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group sessions over 3 weeks</intervention_name>
    <description>Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.</description>
    <arm_group_label>Savvy Express</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group sessions over 6 weeks</intervention_name>
    <description>Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.</description>
    <arm_group_label>Savvy Caregiver Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English- speaking women and men age 18 or older who care for or provide assistance to&#xD;
             someone with dementia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Caregivers who have sensory or physical conditions that interfere with participation&#xD;
             in an on-site, group-administered activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maria P Aranda</last_name>
    <phone>2137401887</phone>
    <email>aranda@usc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Iris Aguilar</last_name>
    <phone>2137401887</phone>
    <email>iaguilar@usc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90015</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria P Aranda, PhD</last_name>
      <phone>213-740-1887</phone>
      <email>aranda@usc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Maria P. Aranda</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>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/NCT04421729
org study id: 5356000538
nct id: NCT04421729
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will conduct a hybrid efficacy-effectiveness trial intended to address
      these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and
      on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los
      Angeles County for feasibility) and Savvy Caregiver Program (original 6-session
      evidenced-based intervention), across post-intervention, 3- and 6-months.
A number of epidemiological studies, systematic reviews, and consensus reports highlight the
      importance of non-pharmacological, sociobehavioural interventions to address the health,
      psychological, and social effects of caregiving for persons living with dementia, and the
      need for tangible information and resources.

      The investigators will conduct a hybrid efficacy-effectiveness trial intended to address
      these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and
      on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los
      Angeles County for feasibility) and Savvy Caregiver Program (original 6-session
      evidenced-based intervention), across post-intervention, 3- and 6-months. It is hypothesized
      that no differences (comparable effects) between the programs in their efficacy/effectiveness
      and moderating conditions.

      Focus groups (~25 participants) will be conducted to ascertain program acceptability and
      satisfaction.

      The analyses will include a multiple linear mixed-effects modeling for our trial outcomes,
      and thematic analyses for our focus group interview data.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: The outcome assessor will not have previous knowledge of the respondent's interventional group assignment.
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: up to 7 months
description: caregiver depressive symptoms
measure: Generalized Anxiety Disorder (GAD-7)
time frame: up to 7 months
description: caregiver anxiety symptoms
measure: Revised Memory and Behavior Problems Checklist (RMBPC)
time frame: up to 7 months
description: caregiver reactivity to family member's memory/behavior problems
measure: Caregiver Competence Scales
time frame: up to 7 months
description: measures caregiver skills, mastery, competence, management of the situation based on the Caregiver Competence, Management and Meaning Scales
measure: Medical Outcomes Study Social Support Survey (MOS)
time frame: up to 7 months
description: Measures caregiver social support using the MOS scale
measure: Intent to Institutionalize
time frame: up to 7 months
description: TA one-item measure that assesses if the caregiver intends to institutionalize the family member in the next 6 months
measure: Family Members Activities of Daily Living (ADL)
time frame: up to 7 months
description: measures family member's activities of daily living using the Katz ADL scale
measure: Family Members Instrumental Activities of Daily Living (IADL)
time frame: up to 7 months
description: measures family member's activities of daily living using the Lawton IDL scale
measure: Caregiver Satisfaction
time frame: up to 7 months
description: This is a measure developed for this specific study to ascertain the study participant's satisfaction with the intervention itself.
arm group label: Savvy Caregiver Program
arm group type: Active Comparator
description: Savvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.
arm group label: Savvy Express
arm group type: Active Comparator
description: Savvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.
intervention type: Behavioral
intervention name: Group sessions over 3 weeks
description: Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.
arm group label: Savvy Express
intervention type: Behavioral
intervention name: Group sessions over 6 weeks
description: Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.
arm group label: Savvy Caregiver Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maria P Aranda
phone: 2137401887
email: aranda@usc.edu
last name: Iris Aguilar
phone: 2137401887
email: iaguilar@usc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Maria P. Aranda
investigator title: Associate Professor
mesh term: Caregiver Burden
sharing ipd: No