<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/NCT03308032</url>
  </required_header>
  <id_info>
    <org_study_id>NIH 1R43HL115924-01</org_study_id>
    <nct_id>NCT03308032</nct_id>
  </id_info>
  <brief_title>Self-Directed Online Training for Chinese Caregivers</brief_title>
  <official_title>Self-Directed Online Training for Chinese Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Environment and Health Group, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Environment and Health Group, Inc.</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 proposed project seeks to develop an online self-directed learning (SDL) intervention&#xD;
      program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia&#xD;
      caregivers. The benefits of such a product may include improved psychological health in&#xD;
      caregivers and a reduction in behavioral disturbances among elderly care recipients with&#xD;
      dementia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this Phase II application is to develop an online self-directed learning&#xD;
      (SDL) intervention program that seeks to improve caregiving and self-care skills among ethnic&#xD;
      Chinese dementia caregivers. The benefits of such a product may include improved&#xD;
      psychological health in caregivers and a reduction in behavioral disturbances among elderly&#xD;
      care recipients with dementia. While online dementia caregiver interventions are advantageous&#xD;
      in reaching broad audiences, these individuals face significant challenges in engaging the&#xD;
      target audience and keeping them engaged throughout the intervention program. The proposed&#xD;
      online SDL skill training intervention addresses these challenges with a comprehensive&#xD;
      engagement design to ensure retention and effective learning in the training program.&#xD;
&#xD;
      All Phase I Study Aims have been successfully completed. The prototype provides preliminary&#xD;
      evidence that an SDL training intervention is able to successfully engage ethnic Chinese&#xD;
      caregivers of elders with dementia, improving perceived self-efficacy to manage caregiving&#xD;
      tasks, while reducing negative emotions in the caregiver. Phase II Specific Aims: The Phase&#xD;
      II study will further develop the prototype into a fully-functioning online SDL skill&#xD;
      training intervention for ethnic Chinese dementia caregivers, and evaluate it in a randomized&#xD;
      control trial. In Specific Aim 1, the research team will develop additional multi-lingual&#xD;
      training video clips to complete the training program, and make them available for&#xD;
      Cantonese-, Mandarin-, and/or English-speaking caregivers from different Chinese cultural&#xD;
      backgrounds. In Specific Aim 2, the research team will develop software that enables and&#xD;
      integrates all engagement design functionalities. In Specific Aim 3, the research team will&#xD;
      conduct a randomized controlled trial to evaluate the effectiveness of the SDL training&#xD;
      intervention based on a comprehensive engagement design (intervention arm) compared to one&#xD;
      that does not rely on a comprehensive engagement design (control arm).&#xD;
&#xD;
      Evidence of the effectiveness of the SDL intervention will contribute to the larger&#xD;
      information and communication technology field, increasing the public's understanding and&#xD;
      basic knowledge of effective engagement in the rapidly growing field of online health&#xD;
      interventions. The comprehensive engagement approach developed through this research could be&#xD;
      transferred to other ethnic minority groups facing dementia caregiving challenges, as well as&#xD;
      other populations facing challenges related to the management of other chronic conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Anticipated">July 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 5, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Stress Level</measure>
    <time_frame>At Week 1 and at Week 12</time_frame>
    <description>Will be assessed using the 10 point Perceived Stress Scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Dementia</condition>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the intervention arm will be invited to connect to a webpage, through either computer or tablet / iPad, where they can login to receive the SDL course. Immediately after the login, and weekly thereafter, participants will receive emails to remind them of the login passwords, to provide them with tracking data on their progress in going through the training lessons. For those who login but do not proceed to take baseline assessment for longer than two days, study staff will contact participants, via the email address or telephone number that was entered during initial registration for login, to answer any questions they might have and to provide assistance to those who have not been able to log onto the site. Those who sign up without taking any courses for 10 days will receive a reminder call by study staff. Intervention arm participants will be invited back via both</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to the intervention arm will be invited to connect to a webpage, through either computer or tablet / iPad, where they can login to receive the SDL course.&#xD;
Immediately after the login, and weekly thereafter, participants will receive emails to remind them of the login passwords, to provide them with tracking data on their progress in going through the training lessons (see below). For those who login but do not proceed to take baseline assessment for longer than two days, study staff will contact participants, via the email address or telephone number that was entered during initial registration for login, to answer any questions they might have and to provide assistance to those who have not been able to log onto the site. Those who sign up without taking any courses for 10 days will receive a reminder call by study staff. Intervention arm participants will be invited back via both</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>SDL intervention employs a comprehensive engagement design that includes seven innovative strategies: 1) customization of content of the training curriculum to fit individual learner's needs; 2) tailoring the length of trainings by using short video clips to allow caregivers flexibility in completing the curriculum; 3) using an instructional format (SCHOLAR) designed to maximize active learning during each training lesson; 4) progress tracking to help the learner stay focused and motivated; 5) a recommendation algorithm that facilitates the learner's transition from one training topic to the next; 6) behavioral economics-based messages, to re-engage the learner if he/she stops participating</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Participants in the control group will be invited to a comparable online training course consisting of all of our training video clips, without the interactive engagement design features. These represent standard video training based on evidence-based content.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ethnic Chinese Caregiver&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not Chinese or Caregiver&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</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/NCT03308032
org study id: NIH 1R43HL115924-01
nct id: NCT03308032
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed project seeks to develop an online self-directed learning (SDL) intervention
      program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia
      caregivers. The benefits of such a product may include improved psychological health in
      caregivers and a reduction in behavioral disturbances among elderly care recipients with
      dementia.
The objective of this Phase II application is to develop an online self-directed learning
      (SDL) intervention program that seeks to improve caregiving and self-care skills among ethnic
      Chinese dementia caregivers. The benefits of such a product may include improved
      psychological health in caregivers and a reduction in behavioral disturbances among elderly
      care recipients with dementia. While online dementia caregiver interventions are advantageous
      in reaching broad audiences, these individuals face significant challenges in engaging the
      target audience and keeping them engaged throughout the intervention program. The proposed
      online SDL skill training intervention addresses these challenges with a comprehensive
      engagement design to ensure retention and effective learning in the training program.

      All Phase I Study Aims have been successfully completed. The prototype provides preliminary
      evidence that an SDL training intervention is able to successfully engage ethnic Chinese
      caregivers of elders with dementia, improving perceived self-efficacy to manage caregiving
      tasks, while reducing negative emotions in the caregiver. Phase II Specific Aims: The Phase
      II study will further develop the prototype into a fully-functioning online SDL skill
      training intervention for ethnic Chinese dementia caregivers, and evaluate it in a randomized
      control trial. In Specific Aim 1, the research team will develop additional multi-lingual
      training video clips to complete the training program, and make them available for
      Cantonese-, Mandarin-, and/or English-speaking caregivers from different Chinese cultural
      backgrounds. In Specific Aim 2, the research team will develop software that enables and
      integrates all engagement design functionalities. In Specific Aim 3, the research team will
      conduct a randomized controlled trial to evaluate the effectiveness of the SDL training
      intervention based on a comprehensive engagement design (intervention arm) compared to one
      that does not rely on a comprehensive engagement design (control arm).

      Evidence of the effectiveness of the SDL intervention will contribute to the larger
      information and communication technology field, increasing the public's understanding and
      basic knowledge of effective engagement in the rapidly growing field of online health
      interventions. The comprehensive engagement approach developed through this research could be
      transferred to other ethnic minority groups facing dementia caregiving challenges, as well as
      other populations facing challenges related to the management of other chronic conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Stress Level
time frame: At Week 1 and at Week 12
description: Will be assessed using the 10 point Perceived Stress Scale
arm group label: Intervention
arm group type: Experimental
description: Participants assigned to the intervention arm will be invited to connect to a webpage, through either computer or tablet / iPad, where they can login to receive the SDL course. Immediately after the login, and weekly thereafter, participants will receive emails to remind them of the login passwords, to provide them with tracking data on their progress in going through the training lessons. For those who login but do not proceed to take baseline assessment for longer than two days, study staff will contact participants, via the email address or telephone number that was entered during initial registration for login, to answer any questions they might have and to provide assistance to those who have not been able to log onto the site. Those who sign up without taking any courses for 10 days will receive a reminder call by study staff. Intervention arm participants will be invited back via both
arm group label: Control
arm group type: Active Comparator
description: Participants assigned to the intervention arm will be invited to connect to a webpage, through either computer or tablet / iPad, where they can login to receive the SDL course.
Immediately after the login, and weekly thereafter, participants will receive emails to remind them of the login passwords, to provide them with tracking data on their progress in going through the training lessons (see below). For those who login but do not proceed to take baseline assessment for longer than two days, study staff will contact participants, via the email address or telephone number that was entered during initial registration for login, to answer any questions they might have and to provide assistance to those who have not been able to log onto the site. Those who sign up without taking any courses for 10 days will receive a reminder call by study staff. Intervention arm participants will be invited back via both
intervention type: Behavioral
intervention name: Intervention
description: SDL intervention employs a comprehensive engagement design that includes seven innovative strategies: 1) customization of content of the training curriculum to fit individual learner's needs; 2) tailoring the length of trainings by using short video clips to allow caregivers flexibility in completing the curriculum; 3) using an instructional format (SCHOLAR) designed to maximize active learning during each training lesson; 4) progress tracking to help the learner stay focused and motivated; 5) a recommendation algorithm that facilitates the learner's transition from one training topic to the next; 6) behavioral economics-based messages, to re-engage the learner if he/she stops participating
arm group label: Intervention
intervention type: Behavioral
intervention name: Control
description: Participants in the control group will be invited to a comparable online training course consisting of all of our training video clips, without the interactive engagement design features. These represent standard video training based on evidence-based content.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Alzheimer Disease