<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/NCT04445077</url>
  </required_header>
  <id_info>
    <org_study_id>2019.500</org_study_id>
    <nct_id>NCT04445077</nct_id>
  </id_info>
  <brief_title>Education Program for Care Home Staff</brief_title>
  <official_title>Effects of a Competency-based Education Program on Care Home Staff's Sense of Competence Related to Dementia Care in Mainland China: A Mixed-methods Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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 competence of care home staff in dementia care is highly influential to the quality of&#xD;
      care that adversely affects both people living with dementia and staff and in Mainland China&#xD;
      where knowledge on dementia among care home staff was generally poor and this area is&#xD;
      under-researched. This study aims at developing a competency-based culturally-sensitive&#xD;
      education program on dementia care for care home staff through literature review, qualitative&#xD;
      study. And then a quasi-experiment design without random assignment will be conducted to&#xD;
      evaluate the effects of this program on care home staff's sense of competence, knowledge,&#xD;
      attitudes, and care approach related to dementia care and staff satisfaction with the&#xD;
      intervention. Focus group interviews will be conducted to understand participants' experience&#xD;
      about the education program after the intervention. This study is expected to provide an&#xD;
      effective way to improve care homes staff's competence in dementia care thereby improve the&#xD;
      quality of care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of sense of competence in dementia care</measure>
    <time_frame>Sense of competence in dementia care changes from baseline to immediately after intervention (2 months).</time_frame>
    <description>Sense of competence in dementia care will be measured by Sense of Competence in dementia care scale.The total score is 17-68 by adding up the score of each item. Higher scores mean higher level of sense of confidence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Sense of competence in dementia care</measure>
    <time_frame>Sense of competence in dementia care changes from immediately after intervention to three months after intervention.</time_frame>
    <description>Sense of competence in dementia care will be measured by Sense of Competence in dementia care scale.The total score is 17-68 by adding up the score of each item. Higher scores mean higher level of sense of confidence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of knowledge on dementia</measure>
    <time_frame>Knowledge on dementia changes from baseline to immediately after intervention (2 months).</time_frame>
    <description>Knowledge on dementia will be assessed by using Dementia Knowledge Assessment Scale. The total score is 0 to 50 by adding up the scores of all items. Higher score means better knowledge on dementia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of knowledge on dementia</measure>
    <time_frame>Knowledge on dementia changes from immediately after intervention to three months after intervention.</time_frame>
    <description>Knowledge on dementia will be assessed by using Dementia Knowledge Assessment Scale. The total score is 0 to 50 by adding up the scores of all items. Higher score means better knowledge on dementia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of attitude towards dementia care</measure>
    <time_frame>Attitude towards dementia care changes from baseline to immediately after intervention (2 months).</time_frame>
    <description>Attitude towards dementia care will be assessed by using Approaches to Dementia Questionnaire. The total score is 19-95 with higher score indicating the more positive attitudes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of attitude towards dementia care</measure>
    <time_frame>Attitude towards dementia care changes from immediately after intervention to three months after intervention.</time_frame>
    <description>Attitude towards dementia care will be assessed by using Approaches to Dementia Questionnaire. The total score is 19-95 with higher score indicating the more positive attitudes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of person-centred care approach</measure>
    <time_frame>Person-centred care approach changes from baseline to immediately after intervention (2 months).</time_frame>
    <description>Person-centred care approach will be assessed by Person-centred care assessment tools. The total score ranges from 15 to 75 with higher score indicating higher degree of person-centred care provision in the institutions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of person-centred care approach</measure>
    <time_frame>Person-centred care approach changes from immediately after intervention to three months after intervention.</time_frame>
    <description>Person-centred care approach will be assessed by Person-centred care assessment tools. The total score ranges from 15 to 75 with higher score indicating higher degree of person-centred care provision in the institutions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of severity of behavioural and psychological symptoms of dementia (BPSD) of residents with dementia</measure>
    <time_frame>Severity of BPSD of residents with dementia changes from baseline to immediately after intervention (2 months).</time_frame>
    <description>Severity of BPSD of residents with dementia will be assessed by Neuropsychiatric Inventory - Nursing Home Version (NPI-NH). The frequency × severity of each item yielded a composite symptom, and total severity scores which ranges from 1 to 36 reflecting the sum of each item score. Higher scores indicate more severe symptoms. The total score of caregiver distress range from 12 to 60, with higher score indicating more severe distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of severity of behavioural and psychological symptoms of dementia (BPSD) of residents with dementia</measure>
    <time_frame>Severity of BPSD of residents with dementia changes from immediately after intervention to three months after intervention.</time_frame>
    <description>Severity of BPSD of residents with dementia will be assessed by Neuropsychiatric Inventory - Nursing Home Version (NPI-NH). The frequency × severity of each item yielded a composite symptom, and total severity scores which ranges from 1 to 36 reflecting the sum of each item score. Higher scores indicate more severe symptoms. The total score of caregiver distress range from 12 to 60, with higher score indicating more severe distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Care staff's satisfaction</measure>
    <time_frame>Care staff's satisfaction will be measured immediately after the intervention in intervention group.</time_frame>
    <description>Care staff's satisfaction will be measured with a self-developed, five-point Likert, five-item scale including satisfaction with educational content, teaching form, provider, usefulness and overall evaluation. The total score ranges from 5 to 25, with higher score representing more dissatisfaction on the training.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Participants' experience about the intervention</measure>
    <time_frame>Focus group interviews will be conducted within one week after the intervention.</time_frame>
    <description>Focus group interviews which will last around 40-60 minutes will be conducted to understand care home staff's experience and their perceptions towards the program.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The education will be delivered weekly with 60-90 minutes per lecture for eight lectures. Multiple teaching methods will be used, including lectures, structured handouts, video, role play, case study and discussion. During the study period, the research team will provide ongoing support and consultation through electronic communication and bimonthly field visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Printed materials will be given to the participants in the control group for their self-study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dementia Competence Education for care home setting</intervention_name>
    <description>The intervention is a competency-based education program for care home staff who provide dementia care in Mainland China.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Printed educational materials</intervention_name>
    <description>The educational materials will be delivered to the participants in the control group for their self-study.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Care homes:&#xD;
&#xD;
          -  having at least 10 people with dementia living in;&#xD;
&#xD;
          -  with at least 10 care staff working for people with dementia;&#xD;
&#xD;
          -  which do not have any educational activities for staff in dementia three months before&#xD;
             the study and staff training plan during the whole study period;&#xD;
&#xD;
          -  whose management level agrees to participate.&#xD;
&#xD;
        Care staff:&#xD;
&#xD;
          -  working for people with dementia;&#xD;
&#xD;
          -  speaking and reading Chinese;&#xD;
&#xD;
          -  being willing to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having any educational activities in dementia three months before the study;&#xD;
&#xD;
          -  having a training plan during the whole study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yayi ZHAO</last_name>
    <phone>(852)54263094</phone>
    <email>zhaoyayi@link.cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>朗诗常青藤养老服务有限公司睿城站</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ping Guo</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Yayi ZHAO</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>dementia</keyword>
  <keyword>long-term care</keyword>
  <keyword>competency</keyword>
  <keyword>education</keyword>
  <keyword>staff</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>Undecided</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/NCT04445077
org study id: 2019.500
nct id: NCT04445077
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The competence of care home staff in dementia care is highly influential to the quality of
      care that adversely affects both people living with dementia and staff and in Mainland China
      where knowledge on dementia among care home staff was generally poor and this area is
      under-researched. This study aims at developing a competency-based culturally-sensitive
      education program on dementia care for care home staff through literature review, qualitative
      study. And then a quasi-experiment design without random assignment will be conducted to
      evaluate the effects of this program on care home staff's sense of competence, knowledge,
      attitudes, and care approach related to dementia care and staff satisfaction with the
      intervention. Focus group interviews will be conducted to understand participants' experience
      about the education program after the intervention. This study is expected to provide an
      effective way to improve care homes staff's competence in dementia care thereby improve the
      quality of care.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change of sense of competence in dementia care
time frame: Sense of competence in dementia care changes from baseline to immediately after intervention (2 months).
description: Sense of competence in dementia care will be measured by Sense of Competence in dementia care scale.The total score is 17-68 by adding up the score of each item. Higher scores mean higher level of sense of confidence.
measure: Change of Sense of competence in dementia care
time frame: Sense of competence in dementia care changes from immediately after intervention to three months after intervention.
description: Sense of competence in dementia care will be measured by Sense of Competence in dementia care scale.The total score is 17-68 by adding up the score of each item. Higher scores mean higher level of sense of confidence.
measure: Change of knowledge on dementia
time frame: Knowledge on dementia changes from baseline to immediately after intervention (2 months).
description: Knowledge on dementia will be assessed by using Dementia Knowledge Assessment Scale. The total score is 0 to 50 by adding up the scores of all items. Higher score means better knowledge on dementia.
measure: Change of knowledge on dementia
time frame: Knowledge on dementia changes from immediately after intervention to three months after intervention.
description: Knowledge on dementia will be assessed by using Dementia Knowledge Assessment Scale. The total score is 0 to 50 by adding up the scores of all items. Higher score means better knowledge on dementia.
measure: Change of attitude towards dementia care
time frame: Attitude towards dementia care changes from baseline to immediately after intervention (2 months).
description: Attitude towards dementia care will be assessed by using Approaches to Dementia Questionnaire. The total score is 19-95 with higher score indicating the more positive attitudes.
measure: Change of attitude towards dementia care
time frame: Attitude towards dementia care changes from immediately after intervention to three months after intervention.
description: Attitude towards dementia care will be assessed by using Approaches to Dementia Questionnaire. The total score is 19-95 with higher score indicating the more positive attitudes.
measure: Change of person-centred care approach
time frame: Person-centred care approach changes from baseline to immediately after intervention (2 months).
description: Person-centred care approach will be assessed by Person-centred care assessment tools. The total score ranges from 15 to 75 with higher score indicating higher degree of person-centred care provision in the institutions.
measure: Change of person-centred care approach
time frame: Person-centred care approach changes from immediately after intervention to three months after intervention.
description: Person-centred care approach will be assessed by Person-centred care assessment tools. The total score ranges from 15 to 75 with higher score indicating higher degree of person-centred care provision in the institutions.
measure: Change of severity of behavioural and psychological symptoms of dementia (BPSD) of residents with dementia
time frame: Severity of BPSD of residents with dementia changes from baseline to immediately after intervention (2 months).
description: Severity of BPSD of residents with dementia will be assessed by Neuropsychiatric Inventory - Nursing Home Version (NPI-NH). The frequency × severity of each item yielded a composite symptom, and total severity scores which ranges from 1 to 36 reflecting the sum of each item score. Higher scores indicate more severe symptoms. The total score of caregiver distress range from 12 to 60, with higher score indicating more severe distress.
measure: Change of severity of behavioural and psychological symptoms of dementia (BPSD) of residents with dementia
time frame: Severity of BPSD of residents with dementia changes from immediately after intervention to three months after intervention.
description: Severity of BPSD of residents with dementia will be assessed by Neuropsychiatric Inventory - Nursing Home Version (NPI-NH). The frequency × severity of each item yielded a composite symptom, and total severity scores which ranges from 1 to 36 reflecting the sum of each item score. Higher scores indicate more severe symptoms. The total score of caregiver distress range from 12 to 60, with higher score indicating more severe distress.
measure: Care staff's satisfaction
time frame: Care staff's satisfaction will be measured immediately after the intervention in intervention group.
description: Care staff's satisfaction will be measured with a self-developed, five-point Likert, five-item scale including satisfaction with educational content, teaching form, provider, usefulness and overall evaluation. The total score ranges from 5 to 25, with higher score representing more dissatisfaction on the training.
measure: Participants' experience about the intervention
time frame: Focus group interviews will be conducted within one week after the intervention.
description: Focus group interviews which will last around 40-60 minutes will be conducted to understand care home staff's experience and their perceptions towards the program.
arm group label: Intervention group
arm group type: Experimental
description: The education will be delivered weekly with 60-90 minutes per lecture for eight lectures. Multiple teaching methods will be used, including lectures, structured handouts, video, role play, case study and discussion. During the study period, the research team will provide ongoing support and consultation through electronic communication and bimonthly field visits.
arm group label: Control group
arm group type: Other
description: Printed materials will be given to the participants in the control group for their self-study.
intervention type: Other
intervention name: Dementia Competence Education for care home setting
description: The intervention is a competency-based education program for care home staff who provide dementia care in Mainland China.
arm group label: Intervention group
intervention type: Other
intervention name: Printed educational materials
description: The educational materials will be delivered to the participants in the control group for their self-study.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yayi ZHAO
phone: (852)54263094
email: zhaoyayi@link.cuhk.edu.hk
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Yayi ZHAO
investigator title: Principal Investigator
mesh term: Dementia
sharing ipd: Undecided