xml: <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/NCT05992467</url>
    </required_header>
    <id_info>
      <org_study_id>George Mason University</org_study_id>
      <nct_id>NCT05992467</nct_id>
    </id_info>
    <brief_title>WECARE: A Behavioral Intervention for Dementia Caregivers</brief_title>
    <acronym>WECARE</acronym>
    <official_title>WECARE: A mHealth Intervention to Enhance Caregiving Mastery Among Chinese American Dementia Caregivers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>George Mason University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>George Mason 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>
        This study aims to pilot test a culturally tailored behavioral intervention called &quot;WECARE&quot;&#xD;
        to enhance caregiving mastery and improve psychosocial wellbeing of Chinese American family&#xD;
        caregivers of persons with Alzheimer's Disease and related dementia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators propose to test a culturally tailored mHealth behavioral intervention to&#xD;
        enhance caregiving mastery and improve psychosocial wellbeing among Chinese American family&#xD;
        caregivers of persons living with Alzheimer's Disease and related dementia. This&#xD;
        intervention, Wellness Enhancement for Caregivers (WECARE), will be delivered via WeChat, a&#xD;
        social media app highly popular among Chinese Americans. About 45 participants will be&#xD;
        recruited for the pilot test. Participants will complete a baseline survey, receive 7-week&#xD;
        WECARE program on their WeChat accounts, complete a follow-up survey 12 weeks after the&#xD;
        baseline, and then a qualitative interview on Zoom.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</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>Efficacy of behavioral intervention in change from baseline in depressive symptoms</measure>
      <time_frame>Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention</time_frame>
      <description>The baseline and follow-up differences in depressive symptoms will be assessed. Depressive symptoms will be measured by the CES-D, a 20-item survey instrument. The total score will be calculated to quantify depressive symptoms. The baseline and follow-up differences in the scores will be calculated.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Efficacy of behavioral intervention in change from baseline in caregiving burden</measure>
      <time_frame>Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention</time_frame>
      <description>The baseline and follow-up differences in caregiving burden will be assessed. Caregiving burden will be measured by the Zarit Burden Interview, a 12-item survey instrument. The total score will be calculated to quantify caregiving burden. The baseline and follow-up differences in the scores will be calculated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of behavioral intervention in change from baseline in life satisfaction</measure>
      <time_frame>Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention</time_frame>
      <description>The baseline and follow-up differences in life satisfaction will be assessed. Life satisfaction will be measured by the Life Satisfaction Scale, a 5-item survey instrument. The total score will be calculated to quantify life satisfaction. The baseline and follow-up differences in the scores will be calculated.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Efficacy of behavioral intervention in change from baseline in caregiving mastery</measure>
      <time_frame>Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention</time_frame>
      <description>The baseline and follow-up differences in caregiving mastery will be assessed. Caregiving mastery will be measured by the Caregiving Mastery Scale, a 7-item survey instrument. The total score will be calculated to quantify caregiving mastery. The baseline and follow-up differences in the scores will be calculated.</description>
    </other_outcome>
    <other_outcome>
      <measure>Efficacy of behavioral intervention in change in care-recipient's problem behaviors</measure>
      <time_frame>Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention</time_frame>
      <description>The baseline and follow-up differences in care-recipient's problem behaviors will be assessed. Care-recipient's problem behaviors will be measured by a list of 20-item problem behaviors. The total score will be calculated to quantify the number of problem behaviors. The baseline and follow-up differences in the scores will be calculated.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Caregiver Burden</condition>
    <condition>Caregiver Stress Syndrome</condition>
    <arm_group>
      <arm_group_label>WECARE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will first complete a baseline survey online, then subscribe to the WECARE official account on their own WeChat accounts and begin receiving the 7-week interactive and personalized program. The program content includes short video clips, pictorial messages, and audio recordings. Each week, the WECARE program is focused on a theme aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Four weeks after the intervention or 11 weeks after the baseline, participants will complete a follow-up survey online.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Wellness Enhancement for Caregivers (WECARE)</intervention_name>
      <description>WECARE behavioral intervention is guided by behavioral theories aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Participants will receive multimedia content on their WeChat account on cellphone or tablet, including short video clips, pictorial messages, short articles, and audio recordings 6 days a week, for 7 weeks.</description>
      <arm_group_label>WECARE</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 21 years or older,&#xD;
  &#xD;
            2. self-identified as Chinese or Chinese American,&#xD;
  &#xD;
            3. speak and read Chinese (Mandarin or Cantonese),&#xD;
  &#xD;
            4. own a smartphone and use WeChat,&#xD;
  &#xD;
            5. living in Washington DC metropolitan, and&#xD;
  &#xD;
            6. currently care for a family member with ADRD and provide care for at least 10 hours a&#xD;
               week.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. do not read or speak Chinese,&#xD;
  &#xD;
            2. care-recipient is in hospice care or have a life expectancy less than 6 months,&#xD;
  &#xD;
            3. signs of severe intellectual deficits or psychotic disorders, or&#xD;
  &#xD;
            4. unable to provide informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Alicia Hong, PhD</last_name>
      <phone>7039931929</phone>
      <email>yhong22@gmu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sarah Clark</last_name>
      <phone>7039936801</phone>
      <email>sclark68@gmu.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>George Mason University</investigator_affiliation>
      <investigator_full_name>Y. Alicia Hong</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
      <mesh_term>Caregiver Burden</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>After the investigators completes primary data collection and the first report from this trial is accepted for publication.</ipd_time_frame>
      <ipd_access_criteria>Researchers will submit a request including the purpose of accessing the data and a data user agreement</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992467
  org study id: George Mason University
  nct id: NCT05992467
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to pilot test a culturally tailored behavioral intervention called "WECARE"
        to enhance caregiving mastery and improve psychosocial wellbeing of Chinese American family
        caregivers of persons with Alzheimer's Disease and related dementia.
  The investigators propose to test a culturally tailored mHealth behavioral intervention to
        enhance caregiving mastery and improve psychosocial wellbeing among Chinese American family
        caregivers of persons living with Alzheimer's Disease and related dementia. This
        intervention, Wellness Enhancement for Caregivers (WECARE), will be delivered via WeChat, a
        social media app highly popular among Chinese Americans. About 45 participants will be
        recruited for the pilot test. Participants will complete a baseline survey, receive 7-week
        WECARE program on their WeChat accounts, complete a follow-up survey 12 weeks after the
        baseline, and then a qualitative interview on Zoom.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Efficacy of behavioral intervention in change from baseline in depressive symptoms
  time frame: Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
  description: The baseline and follow-up differences in depressive symptoms will be assessed. Depressive symptoms will be measured by the CES-D, a 20-item survey instrument. The total score will be calculated to quantify depressive symptoms. The baseline and follow-up differences in the scores will be calculated.
  measure: Efficacy of behavioral intervention in change from baseline in caregiving burden
  time frame: Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
  description: The baseline and follow-up differences in caregiving burden will be assessed. Caregiving burden will be measured by the Zarit Burden Interview, a 12-item survey instrument. The total score will be calculated to quantify caregiving burden. The baseline and follow-up differences in the scores will be calculated.
  measure: Efficacy of behavioral intervention in change from baseline in life satisfaction
  time frame: Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
  description: The baseline and follow-up differences in life satisfaction will be assessed. Life satisfaction will be measured by the Life Satisfaction Scale, a 5-item survey instrument. The total score will be calculated to quantify life satisfaction. The baseline and follow-up differences in the scores will be calculated.
  measure: Efficacy of behavioral intervention in change from baseline in caregiving mastery
  time frame: Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
  description: The baseline and follow-up differences in caregiving mastery will be assessed. Caregiving mastery will be measured by the Caregiving Mastery Scale, a 7-item survey instrument. The total score will be calculated to quantify caregiving mastery. The baseline and follow-up differences in the scores will be calculated.
  measure: Efficacy of behavioral intervention in change in care-recipient's problem behaviors
  time frame: Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
  description: The baseline and follow-up differences in care-recipient's problem behaviors will be assessed. Care-recipient's problem behaviors will be measured by a list of 20-item problem behaviors. The total score will be calculated to quantify the number of problem behaviors. The baseline and follow-up differences in the scores will be calculated.
  arm group label: WECARE
  arm group type: Experimental
  description: Participants will first complete a baseline survey online, then subscribe to the WECARE official account on their own WeChat accounts and begin receiving the 7-week interactive and personalized program. The program content includes short video clips, pictorial messages, and audio recordings. Each week, the WECARE program is focused on a theme aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Four weeks after the intervention or 11 weeks after the baseline, participants will complete a follow-up survey online.
  intervention type: Behavioral
  intervention name: Wellness Enhancement for Caregivers (WECARE)
  description: WECARE behavioral intervention is guided by behavioral theories aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Participants will receive multimedia content on their WeChat account on cellphone or tablet, including short video clips, pictorial messages, short articles, and audio recordings 6 days a week, for 7 weeks.
  arm group label: WECARE
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alicia Hong, PhD
  phone: 7039931929
  email: yhong22@gmu.edu
  last name: Sarah Clark
  phone: 7039936801
  email: sclark68@gmu.edu
  responsible party type: Principal Investigator
  investigator affiliation: George Mason University
  investigator full name: Y. Alicia Hong
  investigator title: Professor
  mesh term: Dementia
  mesh term: Caregiver Burden
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: After the investigators completes primary data collection and the first report from this trial is accepted for publication.
  ipd access criteria: Researchers will submit a request including the purpose of accessing the data and a data user agreement