<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/NCT01695031</url>
  </required_header>
  <id_info>
    <org_study_id>1R34HL109296-01A1</org_study_id>
    <nct_id>NCT01695031</nct_id>
  </id_info>
  <brief_title>Feasibility of an ED Initiated Online Asthma Management Program for Urban Teens</brief_title>
  <acronym>PuffCityED</acronym>
  <official_title>Feasibility of an ED-initiated Online Asthma Management Program for Urban Teens (Puff City-ED)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Augusta University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine the feasibility of conducting a randomized&#xD;
      controlled trial to evaluate the effectiveness of an online, Emergency Department-initiated&#xD;
      asthma management intervention designed to reduce asthma-related morbidity among urban&#xD;
      teenagers aged 13-19 years with uncontrolled asthma. The study will examine issues around&#xD;
      recruitment, participant compliance with the study protocol, Internet access, and attrition.&#xD;
      Investigators will first develop a protocol for recruiting 13-19 year old patients with acute&#xD;
      asthma into an ED-initiated pilot trial of an online asthma management program, describing&#xD;
      recruitment and refusal rates. Investigators will measure participant compliance with the&#xD;
      pilot study protocol including 4 online sessions and a 6 month survey. Investigators will&#xD;
      also measure compliance of the participants parents at baseline and a six month follow up.&#xD;
      Investigators will then use pilot study results to describe the intervention effect on&#xD;
      selected outcomes including ED visits, asthma control as measured by Asthma Control&#xD;
      Questionnaire, functional limitations, quality of life, and behavior change.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participating emergency departments include Henry Ford Main, Henry Ford Fairlane, and Detroit&#xD;
      Medical Center Children's hospital. Eligible teens will be 13-19 years of age. (Including 19&#xD;
      year olds in the the proposed sample means the data is comparable to age categories used by&#xD;
      many federal agencies). Eligibility criteria include: a physician diagnosis of acute asthma&#xD;
      at the ED visit and parent and teen written informed consent/assent. Eligibility criteria can&#xD;
      be confirmed with the help of the ED nursing staff as some teens presenting with symptoms of&#xD;
      acute asthma, may receive an asthma diagnosis for the first time in the ED. Using the&#xD;
      investigator's data from the school-based trial of Puff City, investigators observed that&#xD;
      12.9% (20/155) of teens reporting an ED visit at baseline also reported no physician&#xD;
      diagnosis. This is used as an approximation of the number of participants in the ED pilot&#xD;
      that may be newly diagnosed. Teens previously enrolled in the school-based version of Puff&#xD;
      City will not be eligible to participate in this pilot. Eligible teens are approached by a&#xD;
      recruiter during down time in the ER (while waiting during receiving treatment or while&#xD;
      waiting to be discharged). A study recruiter will provide the teen with an enrollment packet&#xD;
      that includes an informational brochure (SD 1), a consent (SD 2), and an assent form (SD 3).&#xD;
      The recruiter will go through these materials with the parents and teens and answer any&#xD;
      questions they may have about the program. The recruited teens who enroll are randomized to&#xD;
      either treatment or control. Both groups will be asked to complete an online baseline&#xD;
      questionnaire before leaving the ED. An example of this questionnaire has been included with&#xD;
      this application (SD 4). Once the baseline questionnaire is finished, teens will then be&#xD;
      completing 4 online sessions of web-based asthma education on their own time on a computer&#xD;
      with Internet access. Control group will receive commercial websites such as those sponsored&#xD;
      by the American Lung Association; the American Academy of Allergy, Asthma and Immunology; the&#xD;
      Asthma and Allergy Foundation, and others. Treatment group receives the 4 online, tailored&#xD;
      educational sessions. Teens will be encouraged to complete the 4 sessions within 90 days,&#xD;
      with a minimum of 7 days between sessions to allow for behavior change. To regulate dosage,&#xD;
      control participants receive a &quot;time expired&quot; message after 30 minutes of browsing; this time&#xD;
      limit is commensurate with the estimated time needed to complete a tailored session. Teens&#xD;
      will also be asked to complete a 6-month follow-up survey (SD 5).Parents/Guardians of the&#xD;
      enrolled teens will also be asked to complete a baseline questionnaire and a follow-up at 6&#xD;
      months (SD 6-7) in the form of a telephone interview with a trained interviewer.&#xD;
&#xD;
      In YR1 investigators will develop the recruitment protocol, hire and train recruiters, and&#xD;
      establish a study database. Investigators will get on the agenda of CHM ED staff meetings to&#xD;
      orient clinic staff to the intervention, obtain input/feedback, discuss logistics, address&#xD;
      concerns, and answer questions about the project. Prior to recruitment Investigators will&#xD;
      develop signage about the study (as appropriate) for the ED. Recruitment will start in month&#xD;
      six of YR1, with at least two practice runs of the protocol. In YR2, investigators will&#xD;
      continue recruitment and begin 6 month follow-up surveys. Recruitment will end in the fall of&#xD;
      YR2 leaving 6-8 months for completion of follow-up, analysis and write-up. At the end of YR1&#xD;
      and again at the end of YR2, investigators will conduct short, qualitative interviews with ED&#xD;
      and research staff to ensure identification of issues, barriers, and obstacles to conducting&#xD;
      a trial of an ED-initiated version of Puff City.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 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>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emergency Department Visit</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of enrolled teens randomized to the treatment group who return to the ED with acute asthma compared to the proportion of enrolled teens randomized to the control group who return to the ED with acute asthma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma Control Test (ACT)</measure>
    <time_frame>12 months</time_frame>
    <description>Comparison of ACT scores at 12 months post-baseline by randomization group</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Functional Status</measure>
    <time_frame>12 months</time_frame>
    <description>Compare functional status (e.g., symptom-days, symptom-nights, days of restricted activity, school/work days missed, etc.) by randomization group at 12 months</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Acute Asthma</condition>
  <arm_group>
    <arm_group_label>Tailored asthma management program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teens randomized to the experimental arm will receive 4 sessions of web-based, tailored asthma management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Generic web-based education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Teens in the control group will receive generic, web-based asthma education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tailored asthma management program</intervention_name>
    <description>web-based, computer-tailored asthma management intervention delivered every week for 4 weeks</description>
    <arm_group_label>Tailored asthma management program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Generic web-based education</intervention_name>
    <description>Generic, web-based asthma education</description>
    <arm_group_label>Generic web-based education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  13-19 years of age&#xD;
&#xD;
          -  Physician diagnosis of acute asthma at the Emergency Department visit&#xD;
&#xD;
          -  Parent written informed consent&#xD;
&#xD;
          -  Teen written informed assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent/assent&#xD;
&#xD;
          -  No physician diagnosis of asthma&#xD;
&#xD;
          -  Other co-morbidities that make it impossible for individual to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine LM Joseph, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Christine Joseph</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>Urban adolescents</keyword>
  <keyword>Acute asthma</keyword>
  <keyword>Emergency department</keyword>
  <keyword>Computer tailoring</keyword>
  <keyword>Web-based intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_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/NCT01695031
org study id: 1R34HL109296-01A1
nct id: NCT01695031
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The objective of this study is to determine the feasibility of conducting a randomized
      controlled trial to evaluate the effectiveness of an online, Emergency Department-initiated
      asthma management intervention designed to reduce asthma-related morbidity among urban
      teenagers aged 13-19 years with uncontrolled asthma. The study will examine issues around
      recruitment, participant compliance with the study protocol, Internet access, and attrition.
      Investigators will first develop a protocol for recruiting 13-19 year old patients with acute
      asthma into an ED-initiated pilot trial of an online asthma management program, describing
      recruitment and refusal rates. Investigators will measure participant compliance with the
      pilot study protocol including 4 online sessions and a 6 month survey. Investigators will
      also measure compliance of the participants parents at baseline and a six month follow up.
      Investigators will then use pilot study results to describe the intervention effect on
      selected outcomes including ED visits, asthma control as measured by Asthma Control
      Questionnaire, functional limitations, quality of life, and behavior change.
Participating emergency departments include Henry Ford Main, Henry Ford Fairlane, and Detroit
      Medical Center Children's hospital. Eligible teens will be 13-19 years of age. (Including 19
      year olds in the the proposed sample means the data is comparable to age categories used by
      many federal agencies). Eligibility criteria include: a physician diagnosis of acute asthma
      at the ED visit and parent and teen written informed consent/assent. Eligibility criteria can
      be confirmed with the help of the ED nursing staff as some teens presenting with symptoms of
      acute asthma, may receive an asthma diagnosis for the first time in the ED. Using the
      investigator's data from the school-based trial of Puff City, investigators observed that
      12.9% (20/155) of teens reporting an ED visit at baseline also reported no physician
      diagnosis. This is used as an approximation of the number of participants in the ED pilot
      that may be newly diagnosed. Teens previously enrolled in the school-based version of Puff
      City will not be eligible to participate in this pilot. Eligible teens are approached by a
      recruiter during down time in the ER (while waiting during receiving treatment or while
      waiting to be discharged). A study recruiter will provide the teen with an enrollment packet
      that includes an informational brochure (SD 1), a consent (SD 2), and an assent form (SD 3).
      The recruiter will go through these materials with the parents and teens and answer any
      questions they may have about the program. The recruited teens who enroll are randomized to
      either treatment or control. Both groups will be asked to complete an online baseline
      questionnaire before leaving the ED. An example of this questionnaire has been included with
      this application (SD 4). Once the baseline questionnaire is finished, teens will then be
      completing 4 online sessions of web-based asthma education on their own time on a computer
      with Internet access. Control group will receive commercial websites such as those sponsored
      by the American Lung Association; the American Academy of Allergy, Asthma and Immunology; the
      Asthma and Allergy Foundation, and others. Treatment group receives the 4 online, tailored
      educational sessions. Teens will be encouraged to complete the 4 sessions within 90 days,
      with a minimum of 7 days between sessions to allow for behavior change. To regulate dosage,
      control participants receive a "time expired" message after 30 minutes of browsing; this time
      limit is commensurate with the estimated time needed to complete a tailored session. Teens
      will also be asked to complete a 6-month follow-up survey (SD 5).Parents/Guardians of the
      enrolled teens will also be asked to complete a baseline questionnaire and a follow-up at 6
      months (SD 6-7) in the form of a telephone interview with a trained interviewer.

      In YR1 investigators will develop the recruitment protocol, hire and train recruiters, and
      establish a study database. Investigators will get on the agenda of CHM ED staff meetings to
      orient clinic staff to the intervention, obtain input/feedback, discuss logistics, address
      concerns, and answer questions about the project. Prior to recruitment Investigators will
      develop signage about the study (as appropriate) for the ED. Recruitment will start in month
      six of YR1, with at least two practice runs of the protocol. In YR2, investigators will
      continue recruitment and begin 6 month follow-up surveys. Recruitment will end in the fall of
      YR2 leaving 6-8 months for completion of follow-up, analysis and write-up. At the end of YR1
      and again at the end of YR2, investigators will conduct short, qualitative interviews with ED
      and research staff to ensure identification of issues, barriers, and obstacles to conducting
      a trial of an ED-initiated version of Puff City.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Care Provider)
measure: Emergency Department Visit
time frame: 12 months
description: Proportion of enrolled teens randomized to the treatment group who return to the ED with acute asthma compared to the proportion of enrolled teens randomized to the control group who return to the ED with acute asthma
measure: Asthma Control Test (ACT)
time frame: 12 months
description: Comparison of ACT scores at 12 months post-baseline by randomization group
measure: Functional Status
time frame: 12 months
description: Compare functional status (e.g., symptom-days, symptom-nights, days of restricted activity, school/work days missed, etc.) by randomization group at 12 months
arm group label: Tailored asthma management program
arm group type: Experimental
description: Teens randomized to the experimental arm will receive 4 sessions of web-based, tailored asthma management
arm group label: Generic web-based education
arm group type: Active Comparator
description: Teens in the control group will receive generic, web-based asthma education.
intervention type: Behavioral
intervention name: Tailored asthma management program
description: web-based, computer-tailored asthma management intervention delivered every week for 4 weeks
arm group label: Tailored asthma management program
intervention type: Behavioral
intervention name: Generic web-based education
description: Generic, web-based asthma education
arm group label: Generic web-based education
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: No
last name: Christine LM Joseph, PhD, MPH
role: Principal Investigator
affiliation: Henry Ford Health System
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Christine Joseph
investigator title: Senior Scientist
mesh term: Asthma