<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/NCT03032159</url>
  </required_header>
  <id_info>
    <org_study_id>15488</org_study_id>
    <nct_id>NCT03032159</nct_id>
  </id_info>
  <brief_title>Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities</brief_title>
  <acronym>T2B</acronym>
  <official_title>Text2Breathe: Enhance Parent Communication to Reduce Pediatric Asthma Disparities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MultiCare Mary Bridge Children's Hospital &amp; Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Text2Breathe (T2B) is a randomized controlled trial aimed at improving communication between&#xD;
      parents and their children's' primary care providers about asthma. The overarching goal of&#xD;
      this study is to reduce disparities among a population with high rates of pediatric asthma&#xD;
      morbidity. The investigators are testing the efficacy of a short message service&#xD;
      (SMS)-enhanced health communication (HC) intervention (&quot;Text2Breathe&quot;) designed to equip&#xD;
      urban, low-income parents with tools for communicating effectively with their children's&#xD;
      primary care provider (PCP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potentially eligible participants are approached and screened in person during an admission&#xD;
      of their child to the emergency department for asthma care. Those participants randomized to&#xD;
      the intervention will receive additional education on effective communication with their&#xD;
      child's primary care provider (PCP). These participants will also receive educational text&#xD;
      messages for three months after their initial visit. Text messages will include education on&#xD;
      effectively communicating with their child's provider and general asthma information. Both&#xD;
      the control group and intervention group will receive text message reminders to schedule&#xD;
      regular follow up visits with their PCP and get an annual flu shot. Both groups will be&#xD;
      contacted for follow up phone interviews at 3, 6, 12, 18 and 24 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">March 2020</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of emergency department visits for asthma care</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma morbidity measured as the number of days (or nights) of impairment.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of scheduled asthma care visits</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Asthma Self-Management Questionnaire standardized score</measure>
    <time_frame>12 months</time_frame>
    <description>The Asthma Self-Management Questionnaire, recommended by experts convened for the Asthma Outcomes workshop, includes 16 multiple-choice questions regarding knowledge of preventive strategies and controller medication use. Standardized scores (0-100) are generated, with higher scores indicating more knowledge of self-management. Cronbach's alpha was 0.71. Wording of questions has been revised (e.g., &quot;you&quot; = &quot;your child&quot;) to be appropriate for parents of children with asthma.</description>
  </other_outcome>
  <other_outcome>
    <measure>Parental expectations for child's asthma treatment average score</measure>
    <time_frame>12 months</time_frame>
    <description>In accordance with other research of pediatric asthma interventions, to assess parents' beliefs about possible asthma quality of life for their child we will administer an 8-item measure of parental expectations for asthma treatment. Parents respond to statements about their expectations (e.g., &quot;I believe that my child can be symptom free most of the time.&quot;) using a 5-point Likert scale (1=strongly disagree to 5=strongly agree). Total scores are calculated by averaging across responses, and higher scores reflect more optimistic asthma outcome expectations (Cronbach's alpha = 0.70).</description>
  </other_outcome>
  <other_outcome>
    <measure>Parental self-efficacy for communicating with healthcare providers self-competence scale summary score</measure>
    <time_frame>12 months</time_frame>
    <description>The Medical Competence Communication Scale (MCCS) measures patient's perceptions of their own communication during their most recent medical visits. The patient version of the measure is used to assess information giving, seeking and verifying, as well as socio-emotional communication. The MCCS, patient version, consists of 23 items rated on a 5-point Likert scale (1= unimportant to 5= important) with a higher score indicating greater perception of communication competence. Cronbach's alpha ranges from 0.76-0.92 on the various subscales. Only the 16 self-competence items will be administered in this study. Wording of questions will be modified to state &quot;my child's medical problem&quot; rather than &quot;my medical problem.&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Parental asthma management self-efficacy scale summary score</measure>
    <time_frame>12 months</time_frame>
    <description>The Parent Asthma Management Self-Efficacy Scale (PAMSES) is a valid and reliable instrument designed to measure parent self-efficacy in preventing and managing children's asthma attacks. The PAMSES consists of 13 items rated on a 5-point Likert scale (1=not at all sure to 5=completely sure) with a total possible score range of 13 to 65; higher scores indicate greater self-efficacy. Cronbach's alpha in a sample of primarily White mothers was 0.87.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">221</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the control group will receive their usual asthma care from their provider. Additionally, participants in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Text2Breathe Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The &quot;study&quot; group spends about 10-20 minutes learning about ways to have better communication with their child's primary care provider about his/her asthma. Additionally this group is enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Participants randomized to the study group will also receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text2Breathe Study Group</intervention_name>
    <arm_group_label>Text2Breathe Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unlimited text messaging&#xD;
&#xD;
        Is the parent of child who is:&#xD;
&#xD;
          -  Receiving asthma related care in the emergency department&#xD;
&#xD;
          -  2-12 years old inclusive&#xD;
&#xD;
          -  Medicaid insured (no Private insurance)&#xD;
&#xD;
          -  Physician diagnosed asthma for at least 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Is the parent of child who:&#xD;
&#xD;
          -  Has seen a pulmonary or allergy sub-specialist more than once in the last 6 months&#xD;
&#xD;
          -  Has seen a sub-specialist (not pulmonary or allergy) more than once in the last 12&#xD;
             months&#xD;
&#xD;
          -  Has been hospitalized for more than 30 days&#xD;
&#xD;
          -  Is currently enrolled in another asthma program or study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tumaini Coker, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's Hospital and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seattle Children's</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Bridge Children's Hospital at Multi Care Health System</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>April 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Tumaini Coker</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <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/NCT03032159
org study id: 15488
nct id: NCT03032159
lead sponsor: 
collaborator: 
has dmc: No
Text2Breathe (T2B) is a randomized controlled trial aimed at improving communication between
      parents and their children's' primary care providers about asthma. The overarching goal of
      this study is to reduce disparities among a population with high rates of pediatric asthma
      morbidity. The investigators are testing the efficacy of a short message service
      (SMS)-enhanced health communication (HC) intervention ("Text2Breathe") designed to equip
      urban, low-income parents with tools for communicating effectively with their children's
      primary care provider (PCP).
Potentially eligible participants are approached and screened in person during an admission
      of their child to the emergency department for asthma care. Those participants randomized to
      the intervention will receive additional education on effective communication with their
      child's primary care provider (PCP). These participants will also receive educational text
      messages for three months after their initial visit. Text messages will include education on
      effectively communicating with their child's provider and general asthma information. Both
      the control group and intervention group will receive text message reminders to schedule
      regular follow up visits with their PCP and get an annual flu shot. Both groups will be
      contacted for follow up phone interviews at 3, 6, 12, 18 and 24 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Number of emergency department visits for asthma care
time frame: 12 months
measure: Asthma morbidity measured as the number of days (or nights) of impairment.
time frame: 12 months
measure: Number of scheduled asthma care visits
time frame: 12 months
measure: Asthma Self-Management Questionnaire standardized score
time frame: 12 months
description: The Asthma Self-Management Questionnaire, recommended by experts convened for the Asthma Outcomes workshop, includes 16 multiple-choice questions regarding knowledge of preventive strategies and controller medication use. Standardized scores (0-100) are generated, with higher scores indicating more knowledge of self-management. Cronbach's alpha was 0.71. Wording of questions has been revised (e.g., "you" = "your child") to be appropriate for parents of children with asthma.
measure: Parental expectations for child's asthma treatment average score
time frame: 12 months
description: In accordance with other research of pediatric asthma interventions, to assess parents' beliefs about possible asthma quality of life for their child we will administer an 8-item measure of parental expectations for asthma treatment. Parents respond to statements about their expectations (e.g., "I believe that my child can be symptom free most of the time.") using a 5-point Likert scale (1=strongly disagree to 5=strongly agree). Total scores are calculated by averaging across responses, and higher scores reflect more optimistic asthma outcome expectations (Cronbach's alpha = 0.70).
measure: Parental self-efficacy for communicating with healthcare providers self-competence scale summary score
time frame: 12 months
description: The Medical Competence Communication Scale (MCCS) measures patient's perceptions of their own communication during their most recent medical visits. The patient version of the measure is used to assess information giving, seeking and verifying, as well as socio-emotional communication. The MCCS, patient version, consists of 23 items rated on a 5-point Likert scale (1= unimportant to 5= important) with a higher score indicating greater perception of communication competence. Cronbach's alpha ranges from 0.76-0.92 on the various subscales. Only the 16 self-competence items will be administered in this study. Wording of questions will be modified to state "my child's medical problem" rather than "my medical problem."
measure: Parental asthma management self-efficacy scale summary score
time frame: 12 months
description: The Parent Asthma Management Self-Efficacy Scale (PAMSES) is a valid and reliable instrument designed to measure parent self-efficacy in preventing and managing children's asthma attacks. The PAMSES consists of 13 items rated on a 5-point Likert scale (1=not at all sure to 5=completely sure) with a total possible score range of 13 to 65; higher scores indicate greater self-efficacy. Cronbach's alpha in a sample of primarily White mothers was 0.87.
arm group label: Control Group
arm group type: No Intervention
description: Participants randomized to the control group will receive their usual asthma care from their provider. Additionally, participants in the control group will receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.
arm group label: Text2Breathe Study Group
arm group type: Experimental
description: The "study" group spends about 10-20 minutes learning about ways to have better communication with their child's primary care provider about his/her asthma. Additionally this group is enrolled in the Text2Breathe messaging program which sends asthma related educational text messages 2 times a week for 3 months. Participants randomized to the study group will also receive reminder texts to schedule with their child's PCP and to get an annual flu shot. Participants will be surveyed over the phone for 20-30 minutes 3, 6, 12, 18, and 24 months after enrollment.
intervention type: Behavioral
intervention name: Text2Breathe Study Group
arm group label: Text2Breathe Study Group
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Tumaini Coker, MD, MBA
role: Principal Investigator
affiliation: Seattle Children's Hospital and Research Institute
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Tumaini Coker
investigator title: Professor
mesh term: Asthma
sharing ipd: No