<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/NCT04491578</url>
  </required_header>
  <id_info>
    <org_study_id>HMRF 03180198</org_study_id>
    <nct_id>NCT04491578</nct_id>
  </id_info>
  <brief_title>An Advance Care Planning Programme for Persons With Early Stage Dementia in the Community</brief_title>
  <official_title>Effects of an Advance Care Planning Programme for Persons With Early Stage Dementia in the Community: A Quasi-experimental Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hong Kong Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Food and Health Bureau, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hong Kong Metropolitan 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>
      Advance care planning (ACP) has been widely advocated for persons with early stage dementia&#xD;
      (PWEDs) and persons with mild cognitive impairment (MCI). This proposed study attempts to&#xD;
      promote the uptake of ACP for this population and their family caregivers in the community&#xD;
      and to examine the effects of an ACP programme &quot;Have a Say&quot; for this population. It is&#xD;
      hypothesized that participants received the intervention will be more engaged in ACP and&#xD;
      their dyadic concordance on end-of-life care preference with their family caregivers will be&#xD;
      higher after the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to evaluate the impacts of an advance care planning (ACP) programme &quot;Have a&#xD;
      Say&quot; for persons with early stage dementia (PWEDs) or MCI and their family caregivers in the&#xD;
      community. A quasi-experimental study with repeated blinded outcome assessment will be&#xD;
      conducted to assess the effects of an ACP programme on dyads of PWEDs or persons with MCI and&#xD;
      their family caregivers recruited from elderly community centres. Individuals who have a&#xD;
      clinical diagnosis of any form of dementia at the early stage or MCI or have a Global&#xD;
      Deterioration Score (GDS) 3 or 4 will be eligible to this study. Participants will receive a&#xD;
      4-session ACP programme. It includes an educational component, guided reflection and ACP&#xD;
      discussion through a series of group-based activity and dyadic discussion delivered by&#xD;
      trained ACP facilitator and guided by an ACP booklet. Dyads of participants will be provided&#xD;
      with information about the trajectory of dementia, their future healthcare needs and caring&#xD;
      options. Their values and care preferences on future care will be elicited in a consistent&#xD;
      manner. They will be supported to have an individualized ACP discussion. The primary study&#xD;
      outcome is the ACP engagement level of PWEDs. Secondary outcome is the dyadic concordance on&#xD;
      end-of-life care preference. Adverse outcomes such as depression and caregivers' burden will&#xD;
      also be evaluated. Data collection will be conducted at baseline, immediately after, and&#xD;
      one-month after the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2021</start_date>
  <completion_date type="Actual">October 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</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>
    <intervention_model_description>Dyads of participants recruited from all elderly community centres will receive the ACP intervention</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in advance care planning engagement</measure>
    <time_frame>Baseline, immediately after the intervention, 1 month follow up</time_frame>
    <description>The behavior change process in ACP behaviours is measured using a 9-item ACP engagement survey. It covers two sub-scales, self-efficacy and readiness, of ACP engagement. Each item is rated on a 5-point likert scale. The higher score means the higher level of engagement for the ACP behaviour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in dyadic concordance of end-of-life care preferences</measure>
    <time_frame>Baseline, immediately after the intervention, 1 month follow up</time_frame>
    <description>The dyadic concordance on end-of-life care preferences is measured by a modified Life Support Preferences Questionnaire (LSPQ). Dyads of participants are invited to answer individually, simultaneously but separately for a hypothetical scenario featured the prospect of developing into advanced stage of dementia. PWEDs are asked to indicate their preference for receiving three discrete life-sustaining medical treatments (cardio-pulmonary resuscitation, mechanical ventilation and tube feeding) using a 3 point Likert Scale (1=want to attempt; 2=refuse; 3= not sure). The dyadic congruence is determined based on whether both of them choose the same option for end-of-life treatments, regardless that was for active treatment or not, they gained a score of one. Given the nature of ACP is for the dyad to communicate preferences on end-of-life care, no score would be given if anyone in the dyad chose the &quot;not sure&quot; response.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Depression</measure>
    <time_frame>Baseline, immediately after the intervention, 1 month follow up</time_frame>
    <description>The level of depression of PWEDs is measured by the 19-item Cornell Scale for Depression in Dementia (CSDD). It is to evaluate any adverse outcome posed by the intervention on them.</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregivers' stress</measure>
    <time_frame>Baseline, immediately after the intervention, 1 month follow up</time_frame>
    <description>Caregivers' stress is measured by the 12-item Zarit Caregiver Burden Interview. It is to evaluate any adverse outcome posed by the intervention on family caregivers.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Dementia Mild</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>ACP programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It is a theory-driven ACP programme specifically designed for PWEDs or persons with MCI and their family caregivers. The intervention is underpinned by the Bandura's self-efficacy model and shared decision-making model.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACP programme &quot;Have a Say&quot;</intervention_name>
    <description>Each dyad of participants will receive a 4-session ACP programme, which consists of educational components, guided reflection, and dyadic ACP discussion, guided by ACP facilitators and an ACP booklet. It is composed of 2 group-based sessions and 2 dyadic discussions. One hour for each session. The group-based sessions are nurse-led, in which dyads of participants will be provided with information about the trajectory of dementia, their future healthcare needs and caring options. Their values and care preferences on future care will be elicited in a consistent manner. The dyadic sessions are led by trained ACP facilitator. Dyads of participants will be supported to have an individualized ACP discussion. By the end of the programme, each dyad of participants will be given an ACP booklet documenting the ACP process.</description>
    <arm_group_label>ACP programme</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 55 years or over;&#xD;
&#xD;
          -  being Chinese,&#xD;
&#xD;
          -  being a Cantonese speaker,&#xD;
&#xD;
          -  having a Global Deterioration Scale score 3 or 4,&#xD;
&#xD;
          -  having a designated family caregiver willing to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-communicable,&#xD;
&#xD;
          -  mentally incompetent,&#xD;
&#xD;
          -  received an ACP intervention,&#xD;
&#xD;
          -  have previously signed an advance directive,&#xD;
&#xD;
          -  have other life-limiting chronic illnesses with a life expectancy of less than 6&#xD;
             months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chi Yan Cheryl Yeung, MN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HKSKH Lok Man Alice Kwok Integrated Service Centre</name>
      <address>
        <city>Kowloon</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hong Kong Christian Service</name>
      <address>
        <city>Kowloon</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens</name>
      <address>
        <city>Kowloon</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jockey Club Centre for Positive Ageing</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Neighbourhood Advice- Action Council Ma On Shan Neighbourhood Elderly Centre</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Neighbourhood Advice-Action Council Sham Shui Po District Elderly Community Centre</name>
      <address>
        <city>Sham Shui Po</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Neighbourhood Advice-Action Council Tuen Mun District Integrated Services Centre for the Elderly</name>
      <address>
        <city>Tuen Mun</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yau On Lutheran Centre for the Elderly</name>
      <address>
        <city>Tuen Mun</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HKSKH Chuk Yuen Canon Martin District Elderly Community Centre</name>
      <address>
        <city>Wong Tai Sin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pentecostal Church of Hong Kong Ltd.Choi Wan Neighbourhood Elderly Centre</name>
      <address>
        <city>Wong Tai Sin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hong Kong Metropolitan University</investigator_affiliation>
    <investigator_full_name>Ms Cheryl Yeung Chi Yan</investigator_full_name>
    <investigator_title>Senior Lecturer</investigator_title>
  </responsible_party>
  <keyword>advance care planning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT04491578
org study id: HMRF 03180198
nct id: NCT04491578
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Advance care planning (ACP) has been widely advocated for persons with early stage dementia
      (PWEDs) and persons with mild cognitive impairment (MCI). This proposed study attempts to
      promote the uptake of ACP for this population and their family caregivers in the community
      and to examine the effects of an ACP programme "Have a Say" for this population. It is
      hypothesized that participants received the intervention will be more engaged in ACP and
      their dyadic concordance on end-of-life care preference with their family caregivers will be
      higher after the intervention.
This study aims to evaluate the impacts of an advance care planning (ACP) programme "Have a
      Say" for persons with early stage dementia (PWEDs) or MCI and their family caregivers in the
      community. A quasi-experimental study with repeated blinded outcome assessment will be
      conducted to assess the effects of an ACP programme on dyads of PWEDs or persons with MCI and
      their family caregivers recruited from elderly community centres. Individuals who have a
      clinical diagnosis of any form of dementia at the early stage or MCI or have a Global
      Deterioration Score (GDS) 3 or 4 will be eligible to this study. Participants will receive a
      4-session ACP programme. It includes an educational component, guided reflection and ACP
      discussion through a series of group-based activity and dyadic discussion delivered by
      trained ACP facilitator and guided by an ACP booklet. Dyads of participants will be provided
      with information about the trajectory of dementia, their future healthcare needs and caring
      options. Their values and care preferences on future care will be elicited in a consistent
      manner. They will be supported to have an individualized ACP discussion. The primary study
      outcome is the ACP engagement level of PWEDs. Secondary outcome is the dyadic concordance on
      end-of-life care preference. Adverse outcomes such as depression and caregivers' burden will
      also be evaluated. Data collection will be conducted at baseline, immediately after, and
      one-month after the intervention.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Dyads of participants recruited from all elderly community centres will receive the ACP intervention
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in advance care planning engagement
time frame: Baseline, immediately after the intervention, 1 month follow up
description: The behavior change process in ACP behaviours is measured using a 9-item ACP engagement survey. It covers two sub-scales, self-efficacy and readiness, of ACP engagement. Each item is rated on a 5-point likert scale. The higher score means the higher level of engagement for the ACP behaviour.
measure: Change in dyadic concordance of end-of-life care preferences
time frame: Baseline, immediately after the intervention, 1 month follow up
description: The dyadic concordance on end-of-life care preferences is measured by a modified Life Support Preferences Questionnaire (LSPQ). Dyads of participants are invited to answer individually, simultaneously but separately for a hypothetical scenario featured the prospect of developing into advanced stage of dementia. PWEDs are asked to indicate their preference for receiving three discrete life-sustaining medical treatments (cardio-pulmonary resuscitation, mechanical ventilation and tube feeding) using a 3 point Likert Scale (1=want to attempt; 2=refuse; 3= not sure). The dyadic congruence is determined based on whether both of them choose the same option for end-of-life treatments, regardless that was for active treatment or not, they gained a score of one. Given the nature of ACP is for the dyad to communicate preferences on end-of-life care, no score would be given if anyone in the dyad chose the "not sure" response.
measure: Depression
time frame: Baseline, immediately after the intervention, 1 month follow up
description: The level of depression of PWEDs is measured by the 19-item Cornell Scale for Depression in Dementia (CSDD). It is to evaluate any adverse outcome posed by the intervention on them.
measure: Caregivers' stress
time frame: Baseline, immediately after the intervention, 1 month follow up
description: Caregivers' stress is measured by the 12-item Zarit Caregiver Burden Interview. It is to evaluate any adverse outcome posed by the intervention on family caregivers.
arm group label: ACP programme
arm group type: Experimental
description: It is a theory-driven ACP programme specifically designed for PWEDs or persons with MCI and their family caregivers. The intervention is underpinned by the Bandura's self-efficacy model and shared decision-making model.
intervention type: Behavioral
intervention name: ACP programme "Have a Say"
description: Each dyad of participants will receive a 4-session ACP programme, which consists of educational components, guided reflection, and dyadic ACP discussion, guided by ACP facilitators and an ACP booklet. It is composed of 2 group-based sessions and 2 dyadic discussions. One hour for each session. The group-based sessions are nurse-led, in which dyads of participants will be provided with information about the trajectory of dementia, their future healthcare needs and caring options. Their values and care preferences on future care will be elicited in a consistent manner. The dyadic sessions are led by trained ACP facilitator. Dyads of participants will be supported to have an individualized ACP discussion. By the end of the programme, each dyad of participants will be given an ACP booklet documenting the ACP process.
arm group label: ACP programme
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Chi Yan Cheryl Yeung, MN
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Hong Kong Metropolitan University
investigator full name: Ms Cheryl Yeung Chi Yan
investigator title: Senior Lecturer
mesh term: Dementia
mesh term: Cognitive Dysfunction
sharing ipd: No