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/NCT06000397</url>
    </required_header>
    <id_info>
      <org_study_id>20220678-01H</org_study_id>
      <nct_id>NCT06000397</nct_id>
    </id_info>
    <brief_title>Reminder Emails to Improve Pneumococcal Vaccine Completion at 12 Months of Age</brief_title>
    <official_title>Parents' Enhanced Reminder Intervention to Improve Children's Timely Completion of Immunization Series of Pneumococcal Vaccine at the 12-month's Visit</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ottawa Hospital Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ottawa Hospital Research Institute</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 goal of this clinical trial is to assess the effectiveness of enhanced email reminders in&#xD;
        improving vaccine coverage at the 12-month visit in CANImmunize app users. The main questions&#xD;
        it aims to answer are:&#xD;
  &#xD;
          -  Do enhanced email reminders improve coverage of the 12- month dose of the pneumococcal&#xD;
             vaccine and the timely completion of its immunization series at the 12-month's visit in&#xD;
             CANImmunize app users?&#xD;
  &#xD;
          -  What are the predictors of predictors of timely completion of the 12-month's series of&#xD;
             pneumococcal vaccines in the CANImmunize app users?&#xD;
  &#xD;
        Participants will be randomized to either receive enhanced reminder/recall materials via&#xD;
        email or the standard CANImmunize notifications. Researchers will compare the enhanced&#xD;
        reminder group to the standard notification group to see if there is a difference in vaccine&#xD;
        coverage at the 12-month visit.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Receipt of 12-month pneumococcal vaccine</measure>
      <time_frame>12 months of age</time_frame>
      <description>Receipt of the 12-month dose of the pneumococcal vaccine as recorded in the CANImmunize immunization record</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Timeliness of 12-month pneumococcal vaccine</measure>
      <time_frame>12-13 months of age will be considered as timely, after 13 months considered late</time_frame>
      <description>Age at receipt of the 12-month dose of the pneumococcal vaccine as recorded in the CANImmunize immunization record</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">700</enrollment>
    <condition>Pneumococcal Vaccines</condition>
    <condition>Immunization Coverage</condition>
    <arm_group>
      <arm_group_label>Enhanced reminders</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard notifications</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Enhanced reminders</intervention_name>
      <description>The intervention is sending enhanced (modality and frequency) of reminders to CANImmunize App users, in addition to the standard notifications. Specifically:&#xD;
  Deliver reminders and recall emails to parents or guardians of infants waiting for their 12-month dose of pneumococcal vaccine,&#xD;
  Add additional information about the benefits, safety and effectiveness of the pneumococcal vaccine to support increased uptake, and&#xD;
  Provide tips to improve parents' or guardians' self-efficacy in circumventing barriers to timely immunization of children at the 12-month's visit</description>
      <arm_group_label>Enhanced reminders</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard CANImmunize notifications</intervention_name>
      <description>Push notifications at two time points:&#xD;
  two weeks prior to the immunization due date&#xD;
  one week after the immunization due date</description>
      <arm_group_label>Standard notifications</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
          To be included in the study, CANImmunize account holders must have:&#xD;
  &#xD;
            -  Enabled the reception to receive emails from CANImmunize, and&#xD;
  &#xD;
            -  Record(s) for an infant aged between 10- and 11-months, who have already received the&#xD;
               earlier doses of the pneumococcal vaccine in accordance with their&#xD;
               provincial/territorial routine immunization schedule.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  The account holder (parent, or guardian of the child) has an inactive or undelivered&#xD;
               email address, or&#xD;
  &#xD;
            -  No record(s) for an infant aged 10- and 11-months, or&#xD;
  &#xD;
            -  The record for the 10- or 11-month-old indicates that he/she has not received the&#xD;
               prior pneumococcal vaccine doses.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Months</minimum_age>
      <maximum_age>11 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Vaccine coverage</keyword>
    <keyword>Vaccine uptake</keyword>
    <!-- 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/NCT06000397
  org study id: 20220678-01H
  nct id: NCT06000397
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to assess the effectiveness of enhanced email reminders in
        improving vaccine coverage at the 12-month visit in CANImmunize app users. The main questions
        it aims to answer are:
  
          -  Do enhanced email reminders improve coverage of the 12- month dose of the pneumococcal
             vaccine and the timely completion of its immunization series at the 12-month's visit in
             CANImmunize app users?
  
          -  What are the predictors of predictors of timely completion of the 12-month's series of
             pneumococcal vaccines in the CANImmunize app users?
  
        Participants will be randomized to either receive enhanced reminder/recall materials via
        email or the standard CANImmunize notifications. Researchers will compare the enhanced
        reminder group to the standard notification group to see if there is a difference in vaccine
        coverage at the 12-month visit.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Receipt of 12-month pneumococcal vaccine
  time frame: 12 months of age
  description: Receipt of the 12-month dose of the pneumococcal vaccine as recorded in the CANImmunize immunization record
  measure: Timeliness of 12-month pneumococcal vaccine
  time frame: 12-13 months of age will be considered as timely, after 13 months considered late
  description: Age at receipt of the 12-month dose of the pneumococcal vaccine as recorded in the CANImmunize immunization record
  arm group label: Enhanced reminders
  arm group type: Experimental
  arm group label: Standard notifications
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Enhanced reminders
  description: The intervention is sending enhanced (modality and frequency) of reminders to CANImmunize App users, in addition to the standard notifications. Specifically:
  Deliver reminders and recall emails to parents or guardians of infants waiting for their 12-month dose of pneumococcal vaccine,
  Add additional information about the benefits, safety and effectiveness of the pneumococcal vaccine to support increased uptake, and
  Provide tips to improve parents' or guardians' self-efficacy in circumventing barriers to timely immunization of children at the 12-month's visit
  arm group label: Enhanced reminders
  intervention type: Other
  intervention name: Standard CANImmunize notifications
  description: Push notifications at two time points:
  two weeks prior to the immunization due date
  one week after the immunization due date
  arm group label: Standard notifications
  criteria: 
  gender: All
  minimum age: 10 Months
  maximum age: 11 Months
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor