<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/NCT01662583</url>
  </required_header>
  <id_info>
    <org_study_id>AAAJ9354</org_study_id>
    <nct_id>NCT01662583</nct_id>
  </id_info>
  <brief_title>Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children</brief_title>
  <official_title>Pragmatic Clinical Trial of Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Influenza remains a potentially significant and largely preventable source of morbidity and&#xD;
      mortality, yet vaccine coverage is low. Young children are at particular risk for&#xD;
      underimmunization because they may need to receive 2 doses in a current season. Even among&#xD;
      those young children that initiate vaccination, only 40% receive the important second dose,&#xD;
      yet one dose does not confer adequate protection. Low-income, urban children may be at&#xD;
      particular risk of not receiving two doses. While traditional mail and phone immunization&#xD;
      reminders notifying families that a vaccine is due have had limited efficacy in low-income,&#xD;
      urban populations, we have demonstrated the success of using text messages. Comparing the&#xD;
      effectiveness of different forms of reminders on receipt of this critical second dose of&#xD;
      influenza vaccine has not been studied. Besides failure to remember to return for subsequent&#xD;
      doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health&#xD;
      literacy regarding influenza vaccination, particularly associated with understanding the need&#xD;
      for a second dose since not all children require it. Text messaging offers the ability to&#xD;
      combine health literacy promoting information and reminders in a scalable, efficient manner&#xD;
      for populations at high risk for underimmunization, limited health literacy, and influenza&#xD;
      spread. Therefore, the purpose of this study is to determine whether the provision of&#xD;
      interactive vaccine health literacy-promoting information in text message vaccine reminders&#xD;
      improves receipt and timeliness of the second dose of influenza vaccine within a season for&#xD;
      underserved children in need of two doses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Receipt of 2nd Dose of the Influenza Vaccine.</measure>
    <time_frame>by April 30th after receipt of first dose (up to 8 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.</measure>
    <time_frame>by 42 days after dose of first vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">660</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Educational Text Message</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational text message reminder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plain Text Message</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>plain text message reminder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Written reminder only</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>written reminder at time of vaccination</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Text Message</intervention_name>
    <arm_group_label>Educational Text Message</arm_group_label>
    <arm_group_label>Plain Text Message</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Written reminder</intervention_name>
    <arm_group_label>Educational Text Message</arm_group_label>
    <arm_group_label>Plain Text Message</arm_group_label>
    <arm_group_label>Written reminder only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parenting adult of child age 6 months through 8 years&#xD;
&#xD;
          -  Child receives care at study site (visit in last 12 mths)&#xD;
&#xD;
          -  child received influenza vaccine and needs a second this season&#xD;
&#xD;
          -  Parent has cell phone has text message capability&#xD;
&#xD;
          -  Parent speak English or Spanish&#xD;
&#xD;
          -  Can read text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent does not speak English or Spanish&#xD;
&#xD;
          -  Parent does not have cell phone with text messages&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa Stockwell, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University</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>July 2015</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>May 17, 2015</results_first_submitted>
  <results_first_submitted_qc>May 17, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 4, 2015</results_first_posted>
  <last_update_submitted>July 19, 2015</last_update_submitted>
  <last_update_submitted_qc>July 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Melissa Stockwell, MD, MPH</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics and Population and Family Health</investigator_title>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>text message</keyword>
  <keyword>vaccination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Educational Text Message</title>
          <description>Educational text message reminder&#xD;
Text Message&#xD;
Written reminder</description>
        </group>
        <group group_id="P2">
          <title>Plain Text Message</title>
          <description>plain text message reminder&#xD;
Text Message&#xD;
Written reminder</description>
        </group>
        <group group_id="P3">
          <title>Written Reminder Only</title>
          <description>written reminder at time of vaccination&#xD;
Written reminder</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="216"/>
                <participants group_id="P2" count="225"/>
                <participants group_id="P3" count="219"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="216"/>
                <participants group_id="P2" count="225"/>
                <participants group_id="P3" count="219"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Educational Text Message</title>
          <description>Educational text message reminder&#xD;
Text Message&#xD;
Written reminder</description>
        </group>
        <group group_id="B2">
          <title>Plain Text Message</title>
          <description>plain text message reminder&#xD;
Text Message&#xD;
Written reminder</description>
        </group>
        <group group_id="B3">
          <title>Written Reminder Only</title>
          <description>written reminder at time of vaccination&#xD;
Written reminder</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="216"/>
            <count group_id="B2" value="225"/>
            <count group_id="B3" value="219"/>
            <count group_id="B4" value="660"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="216"/>
                    <measurement group_id="B2" value="225"/>
                    <measurement group_id="B3" value="219"/>
                    <measurement group_id="B4" value="660"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="114"/>
                    <measurement group_id="B4" value="327"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="105"/>
                    <measurement group_id="B4" value="333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="216"/>
                    <measurement group_id="B2" value="225"/>
                    <measurement group_id="B3" value="219"/>
                    <measurement group_id="B4" value="660"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Receipt of 2nd Dose of the Influenza Vaccine.</title>
        <time_frame>by April 30th after receipt of first dose (up to 8 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Educational Text Message</title>
            <description>Educational text message reminder&#xD;
Text Message&#xD;
Written reminder</description>
          </group>
          <group group_id="O2">
            <title>Plain Text Message</title>
            <description>plain text message reminder&#xD;
Text Message&#xD;
Written reminder</description>
          </group>
          <group group_id="O3">
            <title>Written Reminder Only</title>
            <description>written reminder at time of vaccination&#xD;
Written reminder</description>
          </group>
        </group_list>
        <measure>
          <title>Receipt of 2nd Dose of the Influenza Vaccine.</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="225"/>
                <count group_id="O3" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.7"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.</title>
        <time_frame>by 42 days after dose of first vaccination</time_frame>
        <population>One patient in the plain text message arm was removed for this analysis because they received the second dose too early and was not re-vaccinated</population>
        <group_list>
          <group group_id="O1">
            <title>Educational Text Message</title>
            <description>Educational text message reminder&#xD;
Text Message&#xD;
Written reminder</description>
          </group>
          <group group_id="O2">
            <title>Plain Text Message</title>
            <description>plain text message reminder&#xD;
Text Message&#xD;
Written reminder</description>
          </group>
          <group group_id="O3">
            <title>Written Reminder Only</title>
            <description>written reminder at time of vaccination&#xD;
Written reminder</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.</title>
          <population>One patient in the plain text message arm was removed for this analysis because they received the second dose too early and was not re-vaccinated</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="224"/>
                <count group_id="O3" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5"/>
                    <measurement group_id="O2" value="33.9"/>
                    <measurement group_id="O3" value="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Educational Text Message</title>
          <description>Educational text message reminder&#xD;
Text Message&#xD;
Written reminder</description>
        </group>
        <group group_id="E2">
          <title>Plain Text Message</title>
          <description>plain text message reminder&#xD;
Text Message&#xD;
Written reminder</description>
        </group>
        <group group_id="E3">
          <title>Written Reminder Only</title>
          <description>written reminder at time of vaccination&#xD;
Written reminder</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="216"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="225"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="216"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="225"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="219"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Melissa Stockwell, MD MPH</name_or_title>
      <organization>Columbia University</organization>
      <phone>212-342-5372</phone>
      <email>mss2112@columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01662583
org study id: AAAJ9354
nct id: NCT01662583
lead sponsor: 
has dmc: No
Influenza remains a potentially significant and largely preventable source of morbidity and
      mortality, yet vaccine coverage is low. Young children are at particular risk for
      underimmunization because they may need to receive 2 doses in a current season. Even among
      those young children that initiate vaccination, only 40% receive the important second dose,
      yet one dose does not confer adequate protection. Low-income, urban children may be at
      particular risk of not receiving two doses. While traditional mail and phone immunization
      reminders notifying families that a vaccine is due have had limited efficacy in low-income,
      urban populations, we have demonstrated the success of using text messages. Comparing the
      effectiveness of different forms of reminders on receipt of this critical second dose of
      influenza vaccine has not been studied. Besides failure to remember to return for subsequent
      doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health
      literacy regarding influenza vaccination, particularly associated with understanding the need
      for a second dose since not all children require it. Text messaging offers the ability to
      combine health literacy promoting information and reminders in a scalable, efficient manner
      for populations at high risk for underimmunization, limited health literacy, and influenza
      spread. Therefore, the purpose of this study is to determine whether the provision of
      interactive vaccine health literacy-promoting information in text message vaccine reminders
      improves receipt and timeliness of the second dose of influenza vaccine within a season for
      underserved children in need of two doses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Receipt of 2nd Dose of the Influenza Vaccine.
time frame: by April 30th after receipt of first dose (up to 8 months)
measure: Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.
time frame: by 42 days after dose of first vaccination
arm group label: Educational Text Message
arm group type: Experimental
description: Educational text message reminder
arm group label: Plain Text Message
arm group type: Experimental
description: plain text message reminder
arm group label: Written reminder only
arm group type: Other
description: written reminder at time of vaccination
intervention type: Other
intervention name: Text Message
arm group label: Educational Text Message
arm group label: Plain Text Message
intervention type: Other
intervention name: Written reminder
arm group label: Educational Text Message
arm group label: Plain Text Message
arm group label: Written reminder only
criteria: 
gender: All
minimum age: 6 Months
maximum age: 9 Years
healthy volunteers: No
last name: Melissa Stockwell, MD MPH
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Melissa Stockwell, MD, MPH
investigator title: Assistant Professor of Pediatrics and Population and Family Health
mesh term: Influenza, Human
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 