<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/NCT03822286</url>
  </required_header>
  <id_info>
    <org_study_id>YLH-10721</org_study_id>
    <nct_id>NCT03822286</nct_id>
  </id_info>
  <brief_title>Development and Evaluation of E-training and Mentoring Support Program on Dementia Care for Home-care Workers</brief_title>
  <official_title>E-training and Mentoring Support Program on Dementia Care for Home-care Workers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tzu Chi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tzu Chi University</source>
  <oversight_info>
    <has_dmc>Yes</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 evaluate the effects of three-month dementia care e-training and mentoring support&#xD;
      program on home-care workers using a two-group randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Home care staff often have insufficient knowledge and skills of caring people with dementia&#xD;
      at home. Many training courses for home care staff are not developed according to their&#xD;
      educational background and workplace needs.&#xD;
&#xD;
      An innovative evidence-based online training with peer support program in dementia care was&#xD;
      developed and consists of online cloud platform with various training courses and resources,&#xD;
      on-the-job mentoring support by senior peers, and social networking in dementia care.&#xD;
&#xD;
      They can access to the online cloud platform by computers or smart phones anytime for&#xD;
      immediate access to information in dementia care. They can also consult with senior peers for&#xD;
      care problems by social network platform and attend monthly dementia care forum.&#xD;
&#xD;
      The interventional group attendance staff will accept 3-month e-training care online course,&#xD;
      which was supervised by the supervisor and participated in the monthly counseling mentoring&#xD;
      support group. The control group will accept the traditional dementedness care traditional&#xD;
      classroom teaching course and will not accept any e-training .&#xD;
&#xD;
      The curriculum and counseling support group will collect information on the knowledge,&#xD;
      attitudes, care abilities, work stress and burnout of the two groups in the pre-test, 3rd and&#xD;
      6th months and learn about their effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dementia Knowledge Assessment Scale</measure>
    <time_frame>6 month</time_frame>
    <description>To evaluate the staff care for knowledge of patients with dementia, range from 0-50, higher values represent the higher the care knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Approach to Dementia Questionnaire</measure>
    <time_frame>6 month</time_frame>
    <description>To evaluate the staff care for Dementia care attitude, range from 19-95, higher values represent the more positive the attitude of the caregiver to dementia care.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sense of Competence in Dementia Care Staff scale</measure>
    <time_frame>6 month</time_frame>
    <description>To evaluate the staff care for demented patients, range from 16-68, higher values represent Staff have good care ability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maslach Burnout Inventory</measure>
    <time_frame>6 month</time_frame>
    <description>To evaluate the Maslach Burnout Inventory,, range from 0-72, higher values represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Taiwan Simple Work Stress Scale</measure>
    <time_frame>6 month</time_frame>
    <description>The main purpose is to measure the working pressure situation. The scale has a total of 38 questions, eight faces, each facing the score range of 0-100 points. The higher the score, the greater the work pressure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>E-training course programs, counseling mentoring supports and support group gatherings meeting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional classroom teaching course programs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>e-training course</intervention_name>
    <description>Home care staff received mainly self-study, you can download e-books on your lithography or personal mobile phone reading and learning, with lively animation, sound and video guide home staff Learn the knowledge of demented care. The e-book course sets out the themes of the eight demented care training courses.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Support group</intervention_name>
    <description>A counseling master mix 8~10 resident staff members, through the counselor to lead the symposium to the case home to implement technical guidance and through the set of social network groups to immediately discuss the care and solutions of dementia cases, and hold once a month in gathering, about 40~60 minutes each time.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>traditional classroom teaching course programs</intervention_name>
    <description>Home care staff received the traditional demented care traditional classroom teaching course and did not accept any e-training and gathering.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Qualified as a care worker for the elderly welfare law, and at least three months as a&#xD;
             home servant,&#xD;
&#xD;
          -  Literacy&#xD;
&#xD;
          -  Can communicate in Mandarin and Taiwanese,&#xD;
&#xD;
          -  Caring for community clients with cognitive impairment or dementia&#xD;
&#xD;
          -  Willing to participate in the study and provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If it does not meet the conditions for receiving the case, it will not be included in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HsinFeng SU, MSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tzu Chi University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>HsinFeng SU, MSN</last_name>
    <phone>886980313695</phone>
    <email>ss205@ems.tcu.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Huei Chuan Sung, PhD</last_name>
    <phone>88638572158</phone>
    <phone_ext>2213</phone_ext>
    <email>sung@tcust.edu.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HsinFeng,Su</name>
      <address>
        <city>Hualien city</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>886980313695</phone>
      <email>ss205@ems.tcu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tzu Chi University</investigator_affiliation>
    <investigator_full_name>Hsin Feng SU</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>home-care worker</keyword>
  <keyword>e-training</keyword>
  <keyword>mentoring support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>November 3, 2020</submitted>
    <returned>November 25, 2020</returned>
  </pending_results>
  <!-- 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/NCT03822286
org study id: YLH-10721
nct id: NCT03822286
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluate the effects of three-month dementia care e-training and mentoring support
      program on home-care workers using a two-group randomized controlled trial.
Home care staff often have insufficient knowledge and skills of caring people with dementia
      at home. Many training courses for home care staff are not developed according to their
      educational background and workplace needs.

      An innovative evidence-based online training with peer support program in dementia care was
      developed and consists of online cloud platform with various training courses and resources,
      on-the-job mentoring support by senior peers, and social networking in dementia care.

      They can access to the online cloud platform by computers or smart phones anytime for
      immediate access to information in dementia care. They can also consult with senior peers for
      care problems by social network platform and attend monthly dementia care forum.

      The interventional group attendance staff will accept 3-month e-training care online course,
      which was supervised by the supervisor and participated in the monthly counseling mentoring
      support group. The control group will accept the traditional dementedness care traditional
      classroom teaching course and will not accept any e-training .

      The curriculum and counseling support group will collect information on the knowledge,
      attitudes, care abilities, work stress and burnout of the two groups in the pre-test, 3rd and
      6th months and learn about their effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Dementia Knowledge Assessment Scale
time frame: 6 month
description: To evaluate the staff care for knowledge of patients with dementia, range from 0-50, higher values represent the higher the care knowledge.
measure: Approach to Dementia Questionnaire
time frame: 6 month
description: To evaluate the staff care for Dementia care attitude, range from 19-95, higher values represent the more positive the attitude of the caregiver to dementia care.
measure: Sense of Competence in Dementia Care Staff scale
time frame: 6 month
description: To evaluate the staff care for demented patients, range from 16-68, higher values represent Staff have good care ability.
measure: Maslach Burnout Inventory
time frame: 6 month
description: To evaluate the Maslach Burnout Inventory,, range from 0-72, higher values represent a worse outcome.
measure: Taiwan Simple Work Stress Scale
time frame: 6 month
description: The main purpose is to measure the working pressure situation. The scale has a total of 38 questions, eight faces, each facing the score range of 0-100 points. The higher the score, the greater the work pressure.
arm group label: Intervention
arm group type: Experimental
description: E-training course programs, counseling mentoring supports and support group gatherings meeting.
arm group label: Control
arm group type: Active Comparator
description: Traditional classroom teaching course programs.
intervention type: Other
intervention name: e-training course
description: Home care staff received mainly self-study, you can download e-books on your lithography or personal mobile phone reading and learning, with lively animation, sound and video guide home staff Learn the knowledge of demented care. The e-book course sets out the themes of the eight demented care training courses.
arm group label: Intervention
intervention type: Other
intervention name: Support group
description: A counseling master mix 8~10 resident staff members, through the counselor to lead the symposium to the case home to implement technical guidance and through the set of social network groups to immediately discuss the care and solutions of dementia cases, and hold once a month in gathering, about 40~60 minutes each time.
arm group label: Intervention
intervention type: Other
intervention name: traditional classroom teaching course programs
description: Home care staff received the traditional demented care traditional classroom teaching course and did not accept any e-training and gathering.
arm group label: Control
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: HsinFeng SU, MSN
role: Principal Investigator
affiliation: Tzu Chi University
last name: HsinFeng SU, MSN
phone: 886980313695
email: ss205@ems.tcu.edu.tw
last name: Huei Chuan Sung, PhD
phone: 88638572158
phone ext: 2213
email: sung@tcust.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Tzu Chi University
investigator full name: Hsin Feng SU
investigator title: Principal Investigator
mesh term: Dementia
submitted: November 3, 2020
returned: November 25, 2020