<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/NCT03030027</url>
  </required_header>
  <id_info>
    <org_study_id>AFC2016</org_study_id>
    <nct_id>NCT03030027</nct_id>
  </id_info>
  <brief_title>Connecting Through Caregiving: Reappraising Intergeneration Relationships</brief_title>
  <acronym>CTC</acronym>
  <official_title>Connecting Through Caregiving: Reappraising Intergeneration Relationships for Dementia Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study is to examine the effects of perspective-taking reappraisals&#xD;
      on the well-being of adult-child dementia caregivers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dementia caregiving presents a particular challenge wherein the adult child is parenting his&#xD;
      or her parents. Facilitating relational insights, the key components of the Connecting&#xD;
      Through Caregiving (CTC) intervention involves the following: 1) enhancing self-awareness of&#xD;
      the caregiver, 2) developing interpersonal empathy of the care-recipient, 3) help-seeking, 4)&#xD;
      balancing self-care and caring for others and 5) negotiating action plans. The CTC&#xD;
      intervention is be evaluated against a basic skill training intervention consisting of&#xD;
      scheduling pleasant events, communicating with the care recipient and other family members.&#xD;
      Dementia caregivers providing at least 14 hours of care per week to a parent living with&#xD;
      dementia are recruited and randomized into one the two conditions. The intervention lasts for&#xD;
      six weeks for both conditions. Intervention in the first week consists of a home visit and a&#xD;
      telephone follow-up. From the second to fifth week, there are weekly four telephone phone&#xD;
      sessions. In the sixth week, there were two more telephone calls to consolidate the&#xD;
      intervention and to review implementation plans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Life Satisfaction (LS): scale</measure>
    <time_frame>Change from Baseline LS through study completion, an average of 2 months</time_frame>
    <description>Each response was rated from to 7 on each of the 5 items of the scale with higher score indicating higher level of life satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Center for Epidemiologic Studies Depressive Scale (CESD)</measure>
    <time_frame>Change from Baseline CESD through study completion, an average of 2 months</time_frame>
    <description>Each response was rated from 0 to 3 on a scale of the frequency of the occurrence of the symptom in the past week. Higher scores would suggest a higher</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Zarit Burden Interview (ZBI)</measure>
    <time_frame>Change from Baseline ZBI through study completion, an average of 2 months</time_frame>
    <description>Each of the 22 items required the caregiver to rate on a 5-point scale ranging from 0 (never) to 4 (nearly always).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Connecting Through Caregiving</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm focuses on perspective-taking reappraisal procedures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Basic Skills Building</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This arm focuses on skill building.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Connecting Through Caregiving</intervention_name>
    <description>The Connecting Through Caregiving intervention focuses on reappraisal exercises on intergeneration relationships in caregiving, involving the following: 1) enhancing self-awareness of the caregiver, 2) developing interpersonal empathy for the care-recipient, 3) help-seeking in caregiving, 4) balancing self-care and caring and 5) negotiating action plans.</description>
    <arm_group_label>Connecting Through Caregiving</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Basic Skills Building</intervention_name>
    <description>Skill building involves: 1) monitoring activities, 2) pleasant event scheduling, 3) communicating with the care recipient, 4) communicating with family members and 5) review implementation</description>
    <arm_group_label>Basic Skills Building</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study participants will be primary caregivers aged 18 or older and who have been&#xD;
             caring for persons (aged 60 or above) with a physician diagnosis of Alzheimer's&#xD;
             disease in the mild to moderate range as determined by the Clinical Dementia Rating&#xD;
             Scale.&#xD;
&#xD;
          -  Primary caregivers are those who have been providing unpaid care for more than 14&#xD;
             hours a week for at least the past three months.&#xD;
&#xD;
          -  The care should involve day-to-day decision-making as well as any of the following:&#xD;
             feeding, dressing, bathing, toileting, housework, preparing meals, medication and&#xD;
             handling finances.&#xD;
&#xD;
          -  They can be daughter/son or daughter-/son-in-law of the care recipients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are as follows: signs of severe intellectual deficits, demonstrated&#xD;
             suicidal ideation, exhibited evidence of psychotic disorders, hearing/ visual&#xD;
             impairment or inability to read or speak Chinese/Cantonese fluently and severe.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alma Au, {PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joey Chan, Master</last_name>
    <phone>852-2766-5504</phone>
    <email>joey.cyc.chan@polyu.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Active Ageing</name>
      <address>
        <city>Kowloon</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alma Au, PhD</last_name>
      <phone>852-2766-7746</phone>
      <phone_ext>7746</phone_ext>
      <email>alma.au@polyu.edu.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>April 12, 2019</last_update_submitted>
  <last_update_submitted_qc>April 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intergeneration</keyword>
  <keyword>Reappraisal</keyword>
  <keyword>Caregiving</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</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/NCT03030027
org study id: AFC2016
nct id: NCT03030027
lead sponsor: 
has dmc: No
The purpose of the present study is to examine the effects of perspective-taking reappraisals
      on the well-being of adult-child dementia caregivers.
Dementia caregiving presents a particular challenge wherein the adult child is parenting his
      or her parents. Facilitating relational insights, the key components of the Connecting
      Through Caregiving (CTC) intervention involves the following: 1) enhancing self-awareness of
      the caregiver, 2) developing interpersonal empathy of the care-recipient, 3) help-seeking, 4)
      balancing self-care and caring for others and 5) negotiating action plans. The CTC
      intervention is be evaluated against a basic skill training intervention consisting of
      scheduling pleasant events, communicating with the care recipient and other family members.
      Dementia caregivers providing at least 14 hours of care per week to a parent living with
      dementia are recruited and randomized into one the two conditions. The intervention lasts for
      six weeks for both conditions. Intervention in the first week consists of a home visit and a
      telephone follow-up. From the second to fifth week, there are weekly four telephone phone
      sessions. In the sixth week, there were two more telephone calls to consolidate the
      intervention and to review implementation plans.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change in Life Satisfaction (LS): scale
time frame: Change from Baseline LS through study completion, an average of 2 months
description: Each response was rated from to 7 on each of the 5 items of the scale with higher score indicating higher level of life satisfaction
measure: Change in Center for Epidemiologic Studies Depressive Scale (CESD)
time frame: Change from Baseline CESD through study completion, an average of 2 months
description: Each response was rated from 0 to 3 on a scale of the frequency of the occurrence of the symptom in the past week. Higher scores would suggest a higher
measure: Change in Zarit Burden Interview (ZBI)
time frame: Change from Baseline ZBI through study completion, an average of 2 months
description: Each of the 22 items required the caregiver to rate on a 5-point scale ranging from 0 (never) to 4 (nearly always).
arm group label: Connecting Through Caregiving
arm group type: Experimental
description: This arm focuses on perspective-taking reappraisal procedures.
arm group label: Basic Skills Building
arm group type: Other
description: This arm focuses on skill building.
intervention type: Behavioral
intervention name: Connecting Through Caregiving
description: The Connecting Through Caregiving intervention focuses on reappraisal exercises on intergeneration relationships in caregiving, involving the following: 1) enhancing self-awareness of the caregiver, 2) developing interpersonal empathy for the care-recipient, 3) help-seeking in caregiving, 4) balancing self-care and caring and 5) negotiating action plans.
arm group label: Connecting Through Caregiving
intervention type: Other
intervention name: Basic Skills Building
description: Skill building involves: 1) monitoring activities, 2) pleasant event scheduling, 3) communicating with the care recipient, 4) communicating with family members and 5) review implementation
arm group label: Basic Skills Building
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alma Au, {PhD
role: Principal Investigator
affiliation: Hong Kong Polytechnic University
last name: Joey Chan, Master
phone: 852-2766-5504
email: joey.cyc.chan@polyu.edu.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Dementia
sharing ipd: No