<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/NCT04479033</url>
  </required_header>
  <id_info>
    <org_study_id>MOH/NIC/COG05/2017-00</org_study_id>
    <nct_id>NCT04479033</nct_id>
  </id_info>
  <brief_title>Caring for Persons With Dementia and Their Caregivers in the Community</brief_title>
  <official_title>Caring for Persons With Dementia and Their Caregivers in the Community: Towards a Sustainable Community Based Dementia Care System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke-NUS Graduate Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Tsao Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke-NUS Graduate Medical School</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 study consists of two phases - i) a comprehensive assessment of biopsychosocial needs&#xD;
      among cognitively impaired persons and their family caregivers residing in the Whampoa&#xD;
      residential estate in Singapore ; ii) a quasi-experimental evaluation of a pilot&#xD;
      community-based dementia care programme administered by a multidisciplinary team of service&#xD;
      providers. The intervention is a physician-enhanced dementia-specific care management&#xD;
      programme that supports client dyads for up to six months and through community care&#xD;
      management, person-centred communication, management of challenging behaviours,&#xD;
      psychoeducation, geriatric medicine, and gerontological approaches. The intervention team&#xD;
      consists of a nurse, social worker, care manager, physician, and 'Dementia Care Program&#xD;
      Assistants' who specifically design personalised meaningful activities to engage persons&#xD;
      living with dementia as well as provide caregivers with training in basic dementia&#xD;
      caregiving.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To provide appropriate care for persons living with dementia (PLWDs) in the community, their&#xD;
      needs (met, unmet, and latent) and that of their caregivers must be understood holistically.&#xD;
      Local studies have yet to comprehensively examine the experiences of community dwelling older&#xD;
      persons living with moderate to severe dementia and their caregivers, and the impact of an&#xD;
      integrated community model of health care and psychosocial support. This study adopts a&#xD;
      mixed-method approach to needs assessment and programme evaluation using qualitative in-depth&#xD;
      interviews and quantitative surveys administered to participants assigned to control and&#xD;
      intervention groups. The Hua-Mei Dementia Care System (HMDCS) is a programme that aims to&#xD;
      empower and support both PLWDs and their caregivers through personalised care management,&#xD;
      dementia-specific education, and cognitive training. The HMDCS addresses the multifaceted&#xD;
      challenges faced by PLWD-caregiver dyads such as behavioural problems, psychological&#xD;
      distress, lack of social participation, stigma, communication barriers, financial strain, and&#xD;
      insufficient social support.&#xD;
&#xD;
      The study aims are to:&#xD;
&#xD;
        1. Explore the perceptions, behaviours, and underlying motivators and inhibitors of PLWDs,&#xD;
           their caregivers, and members of the community&#xD;
&#xD;
        2. Assess the health, social, psychological, and emotional needs of community dwelling&#xD;
           PLWDs and their caregivers&#xD;
&#xD;
        3. Evaluate the effectiveness of the programme in reducing cognitive and functional&#xD;
           decline, caregiver burden, as well as improving self-reported health status, social&#xD;
           wellbeing, and quality of life of PLWD-caregiver dyads&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 27, 2017</start_date>
  <completion_date type="Anticipated">February 27, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 27, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in cognitive impairment at week 24.</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Mini-Mental State Examination is a 30-point test to screen for cognitive impairment. Scores ranging from 20 to 26 indicate some cognitive impairment, 10-19 indicate moderate to severe cognitive impairment and below 10 indicate very severe cognitive impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in caregiver stress and burden at week 24.</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Zarit Burden Interview is a 22-item instrument for measuring the caregiver's perceived burden of providing care. Questions focus on caregiver's health, psychological well-being, finances, social life and relationship between the caregiver and the PLWD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in memory and behaviour problems at week 24.</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Revised Memory and Behavior Problems Checklist is a 24-item (scored on a scale of 0-4) caregiver-report to measure behavioral problems in PLWDs. The items can be summed as a total score and 3 subscale scores in the domains of memory, depression, and disruptive behaviors. Parallel scores for caregiver reaction are also obtained. Such disruptive and challenging behaviors undermine quality of life in PWDs and place both an emotional and financial burden on their caregivers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in health-related quality of life at week 24.</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Euro-Qol-5D- EQ5D is a commonly used 5-item scale to measure health-related quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of intervention</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Cost-effectiveness of the new model of care will be assessed using the incremental cost-effectiveness ratio (ICER) with respect to the control group. Cost will be assessed by recording utilization of health care and long-term care services and their average unit costs. The calculated ICER will show the cost of a quality-adjusted life year (QALY) saved by the new model of care. Effectiveness will be assessed by computing the average quality-adjusted life years left to live by the dementia participant in both groups. As the intervention is not assumed to be life-extending, study groups will only differ through their quality of life as measured by EQ5D weights. We will account for the quality of life of both PLWDs and their caregivers and sum their respective contributions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Dementia</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants assigned to the control group had screened positive for cognitive impairment but refused the intervention. They were provided with a GP referral letter and information on helplines and caregiver support. Follow-up interviews were scheduled at week 24.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly meeting/communication sessions with members of intervention team for a total of 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multidisciplinary collaborative model of community care management</intervention_name>
    <description>An individualised care plan is developed for PLWDs-caregiver dyads who meet/communicate weekly with various members of the HMDCS team depending on the nature of their needs. Each dyad's care plan involves the diagnosis of problems (eg: memory problems, family conflicts, poor nutrition, fall risk, medication compliance, lack of long-term care arrangements), establishment of treatment goals (eg: caregiver education, awareness of long-term care planning, stabilising medical care at home, improving emotional support), and indicating specific interventions (eg: referrals to counsellors, specialist doctors, day rehabilitation centres; consultations at GP clinic; coordination of advanced care planning; installation of home safety devices; training caregivers to detect acute deterioration in PLWDs). Monitoring of the dyads' statuses and updating of care plans are performed throughout the duration of the programme.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60 years of age and above.&#xD;
&#xD;
          -  Singapore citizens or permanent residents.&#xD;
&#xD;
          -  Lives within catchment area of Whampoa Constituency&#xD;
&#xD;
          -  Screened positively for cognitive impairment (MMSE score of 15 and above)&#xD;
&#xD;
          -  PLWDs must have a primary caregiver.&#xD;
&#xD;
          -  Caregivers must be 21 years of age and above.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • PLWDs without a caregiver&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angelique Chan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke-NUS Graduate Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Johan Suen, PhD</last_name>
    <phone>+65 97552066</phone>
    <email>johan@duke-nus.edu.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Angelique Chan, PhD</last_name>
    <phone>6516 5685</phone>
    <phone_ext>65685</phone_ext>
    <email>angelique.Chan@duke-nus.edu.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Duke-NUS Medical School</name>
      <address>
        <city>Singapore</city>
        <zip>169857</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johan Suen, PhD</last_name>
      <phone>+65 97552066</phone>
      <email>johan@duke-nus.edu.sg</email>
    </contact>
    <investigator>
      <last_name>Angelique Chan, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Johan Suen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Duke-NUS Graduate Medical School</investigator_affiliation>
    <investigator_full_name>Angelique Chan</investigator_full_name>
    <investigator_title>Executive Director</investigator_title>
  </responsible_party>
  <keyword>community based care</keyword>
  <keyword>multidisciplinary team</keyword>
  <keyword>comprehensive needs assessment</keyword>
  <keyword>moderate to severe dementia</keyword>
  <keyword>mixed-methods evaluation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04479033
org study id: MOH/NIC/COG05/2017-00
nct id: NCT04479033
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study consists of two phases - i) a comprehensive assessment of biopsychosocial needs
      among cognitively impaired persons and their family caregivers residing in the Whampoa
      residential estate in Singapore ; ii) a quasi-experimental evaluation of a pilot
      community-based dementia care programme administered by a multidisciplinary team of service
      providers. The intervention is a physician-enhanced dementia-specific care management
      programme that supports client dyads for up to six months and through community care
      management, person-centred communication, management of challenging behaviours,
      psychoeducation, geriatric medicine, and gerontological approaches. The intervention team
      consists of a nurse, social worker, care manager, physician, and 'Dementia Care Program
      Assistants' who specifically design personalised meaningful activities to engage persons
      living with dementia as well as provide caregivers with training in basic dementia
      caregiving.
To provide appropriate care for persons living with dementia (PLWDs) in the community, their
      needs (met, unmet, and latent) and that of their caregivers must be understood holistically.
      Local studies have yet to comprehensively examine the experiences of community dwelling older
      persons living with moderate to severe dementia and their caregivers, and the impact of an
      integrated community model of health care and psychosocial support. This study adopts a
      mixed-method approach to needs assessment and programme evaluation using qualitative in-depth
      interviews and quantitative surveys administered to participants assigned to control and
      intervention groups. The Hua-Mei Dementia Care System (HMDCS) is a programme that aims to
      empower and support both PLWDs and their caregivers through personalised care management,
      dementia-specific education, and cognitive training. The HMDCS addresses the multifaceted
      challenges faced by PLWD-caregiver dyads such as behavioural problems, psychological
      distress, lack of social participation, stigma, communication barriers, financial strain, and
      insufficient social support.

      The study aims are to:

        1. Explore the perceptions, behaviours, and underlying motivators and inhibitors of PLWDs,
           their caregivers, and members of the community

        2. Assess the health, social, psychological, and emotional needs of community dwelling
           PLWDs and their caregivers

        3. Evaluate the effectiveness of the programme in reducing cognitive and functional
           decline, caregiver burden, as well as improving self-reported health status, social
           wellbeing, and quality of life of PLWD-caregiver dyads
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Change from baseline in cognitive impairment at week 24.
time frame: Baseline, Week 24
description: Mini-Mental State Examination is a 30-point test to screen for cognitive impairment. Scores ranging from 20 to 26 indicate some cognitive impairment, 10-19 indicate moderate to severe cognitive impairment and below 10 indicate very severe cognitive impairment.
measure: Change from baseline in caregiver stress and burden at week 24.
time frame: Baseline, Week 24
description: Zarit Burden Interview is a 22-item instrument for measuring the caregiver's perceived burden of providing care. Questions focus on caregiver's health, psychological well-being, finances, social life and relationship between the caregiver and the PLWD.
measure: Change from baseline in memory and behaviour problems at week 24.
time frame: Baseline, Week 24
description: Revised Memory and Behavior Problems Checklist is a 24-item (scored on a scale of 0-4) caregiver-report to measure behavioral problems in PLWDs. The items can be summed as a total score and 3 subscale scores in the domains of memory, depression, and disruptive behaviors. Parallel scores for caregiver reaction are also obtained. Such disruptive and challenging behaviors undermine quality of life in PWDs and place both an emotional and financial burden on their caregivers.
measure: Change from baseline in health-related quality of life at week 24.
time frame: Baseline, Week 24
description: Euro-Qol-5D- EQ5D is a commonly used 5-item scale to measure health-related quality of life.
measure: Cost-effectiveness of intervention
time frame: Baseline, Week 24
description: Cost-effectiveness of the new model of care will be assessed using the incremental cost-effectiveness ratio (ICER) with respect to the control group. Cost will be assessed by recording utilization of health care and long-term care services and their average unit costs. The calculated ICER will show the cost of a quality-adjusted life year (QALY) saved by the new model of care. Effectiveness will be assessed by computing the average quality-adjusted life years left to live by the dementia participant in both groups. As the intervention is not assumed to be life-extending, study groups will only differ through their quality of life as measured by EQ5D weights. We will account for the quality of life of both PLWDs and their caregivers and sum their respective contributions.
arm group label: Control
arm group type: No Intervention
description: Participants assigned to the control group had screened positive for cognitive impairment but refused the intervention. They were provided with a GP referral letter and information on helplines and caregiver support. Follow-up interviews were scheduled at week 24.
arm group label: Intervention
arm group type: Experimental
description: Weekly meeting/communication sessions with members of intervention team for a total of 24 weeks.
intervention type: Other
intervention name: Multidisciplinary collaborative model of community care management
description: An individualised care plan is developed for PLWDs-caregiver dyads who meet/communicate weekly with various members of the HMDCS team depending on the nature of their needs. Each dyad's care plan involves the diagnosis of problems (eg: memory problems, family conflicts, poor nutrition, fall risk, medication compliance, lack of long-term care arrangements), establishment of treatment goals (eg: caregiver education, awareness of long-term care planning, stabilising medical care at home, improving emotional support), and indicating specific interventions (eg: referrals to counsellors, specialist doctors, day rehabilitation centres; consultations at GP clinic; coordination of advanced care planning; installation of home safety devices; training caregivers to detect acute deterioration in PLWDs). Monitoring of the dyads' statuses and updating of care plans are performed throughout the duration of the programme.
arm group label: Intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Angelique Chan, PhD
role: Principal Investigator
affiliation: Duke-NUS Graduate Medical School
last name: Johan Suen, PhD
phone: +65 97552066
email: johan@duke-nus.edu.sg
last name: Angelique Chan, PhD
phone: 6516 5685
phone ext: 65685
email: angelique.Chan@duke-nus.edu.sg
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Duke-NUS Graduate Medical School
investigator full name: Angelique Chan
investigator title: Executive Director
mesh term: Dementia