<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/NCT04410380</url>
  </required_header>
  <id_info>
    <org_study_id>19-1545</org_study_id>
    <nct_id>NCT04410380</nct_id>
  </id_info>
  <brief_title>Patient Portal Use by Parents of Spanish-Speaking Children</brief_title>
  <official_title>Patient Portal Use by Parents of Spanish-Speaking Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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 purpose of this study is to determine whether patient portal access is feasible and&#xD;
      useful for Spanish-speaking parents.&#xD;
&#xD;
      Participants will be given an electronic tablet and will be taught how to access their&#xD;
      child's medical record and other electronic health resources using the tablet.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2020</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Parents Activating Patient Portal</measure>
    <time_frame>6 months</time_frame>
    <description>To determine patient portal use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Parent Attitudes Toward Health Information Technology</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>Parent attitudes and perceptions will be assessed by survey at enrollment and 1 month after intervention. Scale name: Reasons to use more health information technology. Range 3-12. Directionality: Higher scores indicate more favorable attitudes toward health information technology</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Patient Engagement</condition>
  <arm_group>
    <arm_group_label>Electronic tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spanish-speaking parents receive electronic tablet and teaching about use</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Electronic tablet provision with teaching</intervention_name>
    <description>Spanish-speaking parents are provided with an electronic tablet and taught how to use it to access health information for their children.</description>
    <arm_group_label>Electronic tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be parent/legal guardians of children receiving care in UNC's Children's Clinics&#xD;
&#xD;
          -  Have Spanish as preferred language of individual identifying as primary caregiver&#xD;
&#xD;
          -  Have never activated MyChart (patient portal)&#xD;
&#xD;
          -  Have internet service at home OR ability to easily access internet service&#xD;
&#xD;
          -  Have at least one child under age 13&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically unstable at time of recruitment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kori Flower, MD, MS, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Hospitals</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04410380
org study id: 19-1545
nct id: NCT04410380
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether patient portal access is feasible and
      useful for Spanish-speaking parents.

      Participants will be given an electronic tablet and will be taught how to access their
      child's medical record and other electronic health resources using the tablet.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Percent of Parents Activating Patient Portal
time frame: 6 months
description: To determine patient portal use.
measure: Change in Parent Attitudes Toward Health Information Technology
time frame: Baseline, 1 month
description: Parent attitudes and perceptions will be assessed by survey at enrollment and 1 month after intervention. Scale name: Reasons to use more health information technology. Range 3-12. Directionality: Higher scores indicate more favorable attitudes toward health information technology
arm group label: Electronic tablet
arm group type: Experimental
description: Spanish-speaking parents receive electronic tablet and teaching about use
intervention type: Behavioral
intervention name: Electronic tablet provision with teaching
description: Spanish-speaking parents are provided with an electronic tablet and taught how to use it to access health information for their children.
arm group label: Electronic tablet
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kori Flower, MD, MS, MPH
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No