<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/NCT04448002</url>
  </required_header>
  <id_info>
    <org_study_id>IRB202000748</org_study_id>
    <secondary_id>R01HL153119</secondary_id>
    <nct_id>NCT04448002</nct_id>
  </id_info>
  <brief_title>AIM2ACT: A Mobile Health Tool to Help Adolescents Self-Manage Asthma</brief_title>
  <acronym>AIM2ACT</acronym>
  <official_title>AIM2ACT: A Mobile Health Tool to Help Adolescents Self-Manage Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</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 aim is to test the efficacy of AIM2ACT and long-term maintenance of treatment effects in&#xD;
      a fully-powered randomized controlled trial with 160 early adolescents with poorly controlled&#xD;
      persistent asthma, ages 12-15 years, and a caregiver&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 23, 2021</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2025</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>
    <intervention_model_description>Block randomization will ensure a 1:1 ratio</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma Control using asthma control questionnaire</measure>
    <time_frame>Change in baseline, post-intervention,3 months, and 6 months, and 12 month follow-up</time_frame>
    <description>Measured via the Asthma Control Test questionnaire which has 5 items that assesses frequency of daytime and nocturnal asthma symptoms, activity limitations, and perceptions of disease control.Adolescents will complete all 5 items independently of caregivers. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score &gt;19 indicates well-controlled asthma.&quot;</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>AIM2ACT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AIM2ACT is the experimental arm for the trial. AIM2ACT is a dyadic mHealth intervention designed to sustain caregiver involvement and monitoring as well as guide dyads through collaborative asthma management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mHealth Attention Control Condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The mHealth attention control condition is the active comparator arm in the trial that accounts for staff attention and novelty of technology based asthma management intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AIM2ACT</intervention_name>
    <description>AIM2ACT is a mobile health tool that is designed to facilitate collaborative asthma management between early adolescents and their caregivers. AIM2ACT contains the following components: 1) ecological momentary assessment to identify personalized strengths and weaknesses in asthma self-management behaviors; 2) collaborative identification and tracking of goals that help early adolescents to become increasingly independent in managing their asthma; and 3) a suite of engaging skills training videos to help dyads understand how to use AIM2ACT and work together to set asthma self-management goals, develop and achieve the goals articulated in a behavioral contract, and engage in problem-solving communication.</description>
    <arm_group_label>AIM2ACT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mHealth Attention Control Condition</intervention_name>
    <description>Dyads in the mHealth attention control condition will not receive personalized asthma management feedback, will not be guided through collaborative identification and tracking of asthma self-management goals, and will not have access to skills training videos. Instead, dyads will receive static educational information on their smartphones about behavioral management techniques they can use to target improving asthma self-management.</description>
    <arm_group_label>mHealth Attention Control Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria are:&#xD;
&#xD;
          1. Adolescent is 12-15 years old&#xD;
&#xD;
          2. Caregiver is between 18-70 years-old&#xD;
&#xD;
          3. Adolescent lives in the residence of caregiver&#xD;
&#xD;
          4. Adolescent and caregiver can speak and read English&#xD;
&#xD;
          5. (a) Adolescent has been diagnosed as having asthma, OR (b) Doctor has stated the&#xD;
             adolescent has asthma, OR (c) Adolescent has had breathing problems in the past 12&#xD;
             months&#xD;
&#xD;
          6. Adolescent has had an active inhaled corticosteroid prescription for ≥ 4 weeks&#xD;
&#xD;
          7. (a) During the past 14 days (that is, during the past fourteen 24-hour periods that&#xD;
             include daytime and nighttime), the adolescent has experienced one or more of the&#xD;
             following: (i) Asthma symptoms such as wheezing, shortness of breath, or tightness in&#xD;
             the chest, or cough on more than 4 separate days; (ii) Woken up because of asthma&#xD;
             symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough on&#xD;
             1 or more separate nights; (iii) Had to slow down or stop play or usual activities or&#xD;
             missed school because of asthma, wheezing, or tightness in the chest, or cough on more&#xD;
             than 4 separate days; (iv) Used any asthma rescue medicine (sometimes called a quick&#xD;
             relief medicine) on more than 4 separate days&#xD;
&#xD;
               -  OR&#xD;
&#xD;
                  (b) In the past year, adolescent has had one or more of the following: (i) 2 or&#xD;
                  more exacerbations requiring oral systemic corticosteroids; (ii) 2 or more&#xD;
                  emergency department visits; (iii) 1 hospitalization; (iv) 2 or more urgent&#xD;
                  medical care visits due to asthma&#xD;
&#xD;
               -  OR&#xD;
&#xD;
                  (c) Adolescent scores 19 or lower on the Asthma Control Test&#xD;
&#xD;
        Exclusion criteria are -&#xD;
&#xD;
        Families will be excluded if:&#xD;
&#xD;
          1. The family is currently involved in an asthma management intervention above and beyond&#xD;
             usual care, OR&#xD;
&#xD;
          2. Adolescent is unable to complete study procedures independently.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David A Fedele, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David A Fedele, Ph.D.</last_name>
    <phone>352-294-5765</phone>
    <email>dfedele@phhp.ufl.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mona Sayedul Huq, PhD</last_name>
    <phone>352-294-8557</phone>
    <email>monahuq@ufl.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UF Health Pediatrics</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Jackson</last_name>
      <phone>352-294-8959</phone>
      <email>ejackson1@ufl.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mona Sayedul Huq, PhD</last_name>
      <phone>305-294-8557</phone>
      <email>monahuq@ufl.edu</email>
    </contact_backup>
    <investigator>
      <last_name>David A Fedele, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent</keyword>
  <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/NCT04448002
org study id: IRB202000748
secondary id: R01HL153119
nct id: NCT04448002
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim is to test the efficacy of AIM2ACT and long-term maintenance of treatment effects in
      a fully-powered randomized controlled trial with 160 early adolescents with poorly controlled
      persistent asthma, ages 12-15 years, and a caregiver
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Block randomization will ensure a 1:1 ratio
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Asthma Control using asthma control questionnaire
time frame: Change in baseline, post-intervention,3 months, and 6 months, and 12 month follow-up
description: Measured via the Asthma Control Test questionnaire which has 5 items that assesses frequency of daytime and nocturnal asthma symptoms, activity limitations, and perceptions of disease control.Adolescents will complete all 5 items independently of caregivers. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma."
arm group label: AIM2ACT
arm group type: Experimental
description: AIM2ACT is the experimental arm for the trial. AIM2ACT is a dyadic mHealth intervention designed to sustain caregiver involvement and monitoring as well as guide dyads through collaborative asthma management.
arm group label: mHealth Attention Control Condition
arm group type: Active Comparator
description: The mHealth attention control condition is the active comparator arm in the trial that accounts for staff attention and novelty of technology based asthma management intervention.
intervention type: Behavioral
intervention name: AIM2ACT
description: AIM2ACT is a mobile health tool that is designed to facilitate collaborative asthma management between early adolescents and their caregivers. AIM2ACT contains the following components: 1) ecological momentary assessment to identify personalized strengths and weaknesses in asthma self-management behaviors; 2) collaborative identification and tracking of goals that help early adolescents to become increasingly independent in managing their asthma; and 3) a suite of engaging skills training videos to help dyads understand how to use AIM2ACT and work together to set asthma self-management goals, develop and achieve the goals articulated in a behavioral contract, and engage in problem-solving communication.
arm group label: AIM2ACT
intervention type: Behavioral
intervention name: mHealth Attention Control Condition
description: Dyads in the mHealth attention control condition will not receive personalized asthma management feedback, will not be guided through collaborative identification and tracking of asthma self-management goals, and will not have access to skills training videos. Instead, dyads will receive static educational information on their smartphones about behavioral management techniques they can use to target improving asthma self-management.
arm group label: mHealth Attention Control Condition
criteria: 
gender: All
minimum age: 12 Years
maximum age: 70 Years
healthy volunteers: No
last name: David A Fedele, Ph.D.
role: Principal Investigator
affiliation: University of Florida
last name: David A Fedele, Ph.D.
phone: 352-294-5765
email: dfedele@phhp.ufl.edu
last name: Mona Sayedul Huq, PhD
phone: 352-294-8557
email: monahuq@ufl.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No