<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/NCT02231957</url>
  </required_header>
  <id_info>
    <org_study_id>AAAM3756</org_study_id>
    <nct_id>NCT02231957</nct_id>
  </id_info>
  <brief_title>Text Message Vaccine Reminders for Adolescents With Chronic Medical Conditions</brief_title>
  <official_title>Text Message Vaccine Reminders for Adolescents With Chronic Medical Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are a growing number of adolescents with chronic medical conditions in the United&#xD;
      States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination&#xD;
      and annual influenza vaccination of all adolescents. Pneumococcal polysaccharide vaccination&#xD;
      is also recommended for certain high-risk patients. Limited studies suggest that vaccination&#xD;
      coverage of this population remains sub-optimal. Text message vaccine reminder/recall has&#xD;
      been shown to be effective in increasing uptake of select pediatric and adolescents vaccines,&#xD;
      but has yet to be examined among patients with chronic medical conditions who may also face&#xD;
      unique barriers to vaccination. This intervention aims to implement and evaluate the use of&#xD;
      text message vaccine reminders among urban low-income minority adolescents with chronic&#xD;
      medical conditions. This investigator-initiated study is supported in part by a grant from&#xD;
      the Pfizer Medical Education Group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Health Services Research</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)</measure>
    <time_frame>12 weeks after intervention start</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)</measure>
    <time_frame>4 weeks after intervention start</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)</measure>
    <time_frame>24 weeks after intervention start</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination</measure>
    <time_frame>4 weeks after intervention start</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination</measure>
    <time_frame>12 weeks after intervention start</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination</measure>
    <time_frame>24 weeks after intervention start</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">416</enrollment>
  <condition>Vaccination</condition>
  <arm_group>
    <arm_group_label>educational text message reminders</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>receipt of education-embedded text message vaccine reminders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional text message reminders</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>receipt of conventional text message vaccine reminders</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>educational text message reminders</intervention_name>
    <arm_group_label>educational text message reminders</arm_group_label>
    <other_name>educational text message vaccine reminders</other_name>
    <other_name>education-embedded text message vaccine reminders</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional text message reminders</intervention_name>
    <arm_group_label>conventional text message reminders</arm_group_label>
    <other_name>conventional text message vaccine reminders</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Parent with&#xD;
&#xD;
          1. adolescent aged 11-17 years;&#xD;
&#xD;
          2. adolescent with ≥1 chronic medical condition;&#xD;
&#xD;
          3. adolescent with clinic visit in last 12 months;&#xD;
&#xD;
          4. cell phone number listed in hospital registration system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Parent who:&#xD;
&#xD;
          1. does not speak English or Spanish;&#xD;
&#xD;
          2. is unwilling to receive text message vaccine reminders;&#xD;
&#xD;
          3. anticipates moving from area in coming 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annika M Hofstetter, MD, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NewYork-Presbyterian Hospital/Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Annika Hofstetter</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_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/NCT02231957
org study id: AAAM3756
nct id: NCT02231957
lead sponsor: 
collaborator: 
has dmc: No
There are a growing number of adolescents with chronic medical conditions in the United
      States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination
      and annual influenza vaccination of all adolescents. Pneumococcal polysaccharide vaccination
      is also recommended for certain high-risk patients. Limited studies suggest that vaccination
      coverage of this population remains sub-optimal. Text message vaccine reminder/recall has
      been shown to be effective in increasing uptake of select pediatric and adolescents vaccines,
      but has yet to be examined among patients with chronic medical conditions who may also face
      unique barriers to vaccination. This intervention aims to implement and evaluate the use of
      text message vaccine reminders among urban low-income minority adolescents with chronic
      medical conditions. This investigator-initiated study is supported in part by a grant from
      the Pfizer Medical Education Group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)
time frame: 12 weeks after intervention start
measure: Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)
time frame: 4 weeks after intervention start
measure: Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)
time frame: 24 weeks after intervention start
measure: Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination
time frame: 4 weeks after intervention start
measure: Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination
time frame: 12 weeks after intervention start
measure: Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination
time frame: 24 weeks after intervention start
arm group label: educational text message reminders
arm group type: Experimental
description: receipt of education-embedded text message vaccine reminders
arm group label: conventional text message reminders
arm group type: Active Comparator
description: receipt of conventional text message vaccine reminders
intervention type: Other
intervention name: educational text message reminders
arm group label: educational text message reminders
other name: educational text message vaccine reminders
other name: education-embedded text message vaccine reminders
intervention type: Other
intervention name: conventional text message reminders
arm group label: conventional text message reminders
other name: conventional text message vaccine reminders
criteria: 
gender: All
minimum age: 11 Years
maximum age: N/A
healthy volunteers: No
last name: Annika M Hofstetter, MD, PhD, MPH
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Annika Hofstetter
investigator title: Assistant Professor of Pediatrics
mesh term: Vaccines