xml: <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/NCT06004323</url>
    </required_header>
    <id_info>
      <org_study_id>HSEARS20210902004</org_study_id>
      <nct_id>NCT06004323</nct_id>
    </id_info>
    <brief_title>Digital Health Literacy on COVID-19 for All: Co-creation and Evaluation of Interventions for Ethnic Minorities and Chinese People With Chronic Illnesses in Hong Kong</brief_title>
    <official_title>Digital Health Literacy on COVID-19 for All: Co-creation and Evaluation of Interventions for Ethnic Minorities and Chinese People With Chronic Illnesses in Hong Kong</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Hong Kong Polytechnic University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Hong Kong Polytechnic 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>
        During the pandemic, people are anxious for information, and electronic platform serves the&#xD;
        purpose of having first-hand health information and spreading it to massive population within&#xD;
        a short time. However, the source and credibility of the influx of online information are&#xD;
        hard to be verified. Digital health literacy (DHL) is the capacity to access, understand,&#xD;
        evaluate, and apply health information from electronic sources, which is an important&#xD;
        attribute that everyone should possess. Recent studies from our group in Hong Kong have shown&#xD;
        that, during the COVID-19 pandemic, DHL is an issue facing people of all ages, especially&#xD;
        ethnic minorities (EMs), people with chronic illnesses (PWCI), and professional and lay&#xD;
        caregivers (CGs). Considering that, the present research project aims to co-create DHL&#xD;
        interventions with these three groups of people to meet their specific needs in DHL, in&#xD;
        addition, to assess the efficacy of the DHL interventions on eHealth literacy, vaccine&#xD;
        literacy, and actions taken for COVID-19 prevention. The present research is a 4-year&#xD;
        project, involving three phases. Phase 1 involves focus group interviews and cognitive&#xD;
        interviews with the three groups of people for developing interventions and evaluating the&#xD;
        proposed interventions. Phase 2 involves individual interviews with the three groups of&#xD;
        people for testing the feasibility and acceptability of the interventions. Phase 3 involves a&#xD;
        6-month longitudinal quantitative research, testing for the efficacy of the interventions in&#xD;
        three dimensions: literacy, attitude, and behavior. Participants from the three groups will&#xD;
        be invited to join virtual or face-to-face training, watch short videos on social media,&#xD;
        participate in virtual bi-weekly group discussion, and fill in questionnaires for five times&#xD;
        during the course of the study. This co-creation of new knowledge by stakeholders and&#xD;
        researchers is expected to increase the uptake of the research outcomes and adoption of the&#xD;
        DHL interventions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>This is a single-blinded, randomized controlled trial that outcome assessors will be prevented from having knowledge of the interventions assigned to individual participant</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>eHealth Literacy Efficacy</measure>
      <time_frame>baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up</time_frame>
      <description>Measured by the eHealth Literacy scale (eHEAL), an 8-item self-reported efficacy scale scored on a 5-point Likert scale</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Digital Health Literacy</measure>
      <time_frame>baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up</time_frame>
      <description>Measured by Digital Health Literacy Instrument</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vaccine literacy</measure>
      <time_frame>baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up</time_frame>
      <description>knowledge about and intention to receive the COVID-19 vaccine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knowledge, attitudes, and practices towards COVID-19</measure>
      <time_frame>baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up</time_frame>
      <description>Assess knowledge, attitudes, and practices towards COVID-19</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">528</enrollment>
    <condition>Digital Health Literacy</condition>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Digital health literacy intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The interventions will be developed based on the Best Practices for Digital Health Literacy, WHO health literacy toolkits and the findings of the interviews. The content to be covered in the intervention will include news about vaccines; alerts about COVID-19 preventive measures; guidelines on social distancing, COVID-19 screening test arrangements, vaccination and compulsory quarantines; COVID-19-related law enforcement; and self-monitoring of COVID-19 symptoms</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention will be provided to the control group</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Digital health literacy intervention</intervention_name>
      <description>Participants from the intervention group will be invited to join virtual or face-to-face training, watch short videos on social media, participate in virtual bi-weekly group discussion, and fill in questionnaires for five times during the course of the study</description>
      <arm_group_label>Digital health literacy intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ethnic minorities (EMs), people with chronic illnesses (PWCI), and caregivers (CGs)&#xD;
  &#xD;
            -  able to use a computer, smartphone, or laptop to access the Internet at home&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of an acute psychotic disease or life-limiting condition; having a visual,&#xD;
               auditory, or fine motor disorder.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Angela Leung, PhD</last_name>
      <phone>27665587</phone>
      <email>angela.ym.leung@polyu.edu.hk</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
      <investigator_full_name>Dr Angela Leung</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Digital health literacy</keyword>
    <keyword>COVID-19</keyword>
    <keyword>Ethnic minorities</keyword>
    <keyword>Chinese people with chronic illnesses</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Chronic Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data can be obtained from principal investigator.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004323
  org study id: HSEARS20210902004
  nct id: NCT06004323
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  During the pandemic, people are anxious for information, and electronic platform serves the
        purpose of having first-hand health information and spreading it to massive population within
        a short time. However, the source and credibility of the influx of online information are
        hard to be verified. Digital health literacy (DHL) is the capacity to access, understand,
        evaluate, and apply health information from electronic sources, which is an important
        attribute that everyone should possess. Recent studies from our group in Hong Kong have shown
        that, during the COVID-19 pandemic, DHL is an issue facing people of all ages, especially
        ethnic minorities (EMs), people with chronic illnesses (PWCI), and professional and lay
        caregivers (CGs). Considering that, the present research project aims to co-create DHL
        interventions with these three groups of people to meet their specific needs in DHL, in
        addition, to assess the efficacy of the DHL interventions on eHealth literacy, vaccine
        literacy, and actions taken for COVID-19 prevention. The present research is a 4-year
        project, involving three phases. Phase 1 involves focus group interviews and cognitive
        interviews with the three groups of people for developing interventions and evaluating the
        proposed interventions. Phase 2 involves individual interviews with the three groups of
        people for testing the feasibility and acceptability of the interventions. Phase 3 involves a
        6-month longitudinal quantitative research, testing for the efficacy of the interventions in
        three dimensions: literacy, attitude, and behavior. Participants from the three groups will
        be invited to join virtual or face-to-face training, watch short videos on social media,
        participate in virtual bi-weekly group discussion, and fill in questionnaires for five times
        during the course of the study. This co-creation of new knowledge by stakeholders and
        researchers is expected to increase the uptake of the research outcomes and adoption of the
        DHL interventions.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: This is a single-blinded, randomized controlled trial that outcome assessors will be prevented from having knowledge of the interventions assigned to individual participant
  measure: eHealth Literacy Efficacy
  time frame: baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up
  description: Measured by the eHealth Literacy scale (eHEAL), an 8-item self-reported efficacy scale scored on a 5-point Likert scale
  measure: Digital Health Literacy
  time frame: baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up
  description: Measured by Digital Health Literacy Instrument
  measure: Vaccine literacy
  time frame: baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up
  description: knowledge about and intention to receive the COVID-19 vaccine
  measure: Knowledge, attitudes, and practices towards COVID-19
  time frame: baseline, 8-week post intervention, 4-week post follow-up, 8-week follow up, and 12 week follow up
  description: Assess knowledge, attitudes, and practices towards COVID-19
  arm group label: Digital health literacy intervention
  arm group type: Experimental
  description: The interventions will be developed based on the Best Practices for Digital Health Literacy, WHO health literacy toolkits and the findings of the interviews. The content to be covered in the intervention will include news about vaccines; alerts about COVID-19 preventive measures; guidelines on social distancing, COVID-19 screening test arrangements, vaccination and compulsory quarantines; COVID-19-related law enforcement; and self-monitoring of COVID-19 symptoms
  arm group label: Control
  arm group type: No Intervention
  description: No intervention will be provided to the control group
  intervention type: Behavioral
  intervention name: Digital health literacy intervention
  description: Participants from the intervention group will be invited to join virtual or face-to-face training, watch short videos on social media, participate in virtual bi-weekly group discussion, and fill in questionnaires for five times during the course of the study
  arm group label: Digital health literacy intervention
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Angela Leung, PhD
  phone: 27665587
  email: angela.ym.leung@polyu.edu.hk
  responsible party type: Principal Investigator
  investigator affiliation: The Hong Kong Polytechnic University
  investigator full name: Dr Angela Leung
  investigator title: Professor
  mesh term: COVID-19
  mesh term: Chronic Disease
  sharing ipd: No
  ipd description: Data can be obtained from principal investigator.