xml: <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/NCT05999032</url>
    </required_header>
    <id_info>
      <org_study_id>R01HL159701</org_study_id>
      <nct_id>NCT05999032</nct_id>
    </id_info>
    <brief_title>The Puerto Rico Asthma Integrated Response Program (&quot;PR-AIR&quot;)</brief_title>
    <acronym>PR-AIR</acronym>
    <official_title>The Puerto Rico Asthma Integrated Response Program (&quot;PR-AIR&quot;)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rhode Island Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Puerto Rico</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rhode Island Hospital</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 purpose of this study is to adapt and deliver an evidence-based multi-level intervention&#xD;
        to reduce asthma disparities, and that promote and improve population health in the&#xD;
        high-burden communities of San Juan, Puerto Rico.&#xD;
  &#xD;
        The Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated&#xD;
        to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This&#xD;
        study unfolds in two phases: In Phase 1, the researchers will collaborate with community&#xD;
        stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2&#xD;
        consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods&#xD;
        of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption,&#xD;
        Implementation, and Maintenance) framework and a mixed methods approach.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        During the formative evaluation (Phase 1), the researchers will engage community stakeholders&#xD;
        (primary caregivers of children with asthma, school personnel, asthma healthcare providers)&#xD;
        to help identify, adapt and finalize strategies for PR-AIR implementation. The Consolidated&#xD;
        Framework for Implementation Research (CFIR) will be used to identify barriers and&#xD;
        facilitators of low-intensity and high-intensity implementation approaches, the Adaptome to&#xD;
        guide intervention adaptation to the context of PR, and the CFIR-ERIC matching tool to&#xD;
        identify strategies to support but low- and high-intensity implementation packages. Fifteen&#xD;
        stakeholders will complete in-depth interviews early in Phase 1, and 16 will participate in&#xD;
        two focus groups at the end of Phase 1 prior to the transition to Phase 2, in preparation for&#xD;
        trial implementation. A collaborative of community stakeholders will be convened (the PR-AIR&#xD;
        CC) to provide input throughout both phases of the trial.&#xD;
  &#xD;
        In Phase 2 (Years 2-4) 480 urban children will be enrolled, ages 2-12 (expected retention for&#xD;
        full protocol, n = 400) with asthma across 12 areas in San Juan with high asthma burden.&#xD;
        Randomization is at the level of targeted geographic area, and data will be collected from&#xD;
        groups in each of these areas over time. Individual-level (asthma control, QOL) and&#xD;
        community-specific (ED use/hospitalizations, school absence) effectiveness outcomes will be&#xD;
        evaluated. All families will participate in both a control (in our case, baseline period for&#xD;
        the community indicators) and intervention (active trial). Each target area will begin with a&#xD;
        low-intensity (virtual) implementation phase, and transition to a high-intensity&#xD;
        implementation phase mid-year. Families enrolled in the first 5 months of the school year&#xD;
        will receive the low-intensity intervention package, and those enrolled in the last 5 months&#xD;
        of the school year will receive the high-intensity intervention package. Input will be&#xD;
        collected throughout each year from community stakeholders about the trial, through in-depth&#xD;
        interviews and surveys. Reach, Adoption, Implementation, and Maintenance will be measured&#xD;
        using a mixed-methods approach at the end of each trial year (years 2 - 4). Repeated&#xD;
        assessments will measure individual-level effectiveness outcomes (asthma control, QOL) at&#xD;
        time points linked to the start of intervention participation; at enrollment, end of&#xD;
        treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every&#xD;
        3 months for 1 year.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Child Asthma Control (Individual Level, ages 2-4 years)</measure>
      <time_frame>Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.</time_frame>
      <description>Effectiveness of the intervention on child-level asthma control is measured using the Test for Respiratory and Asthma Control in Kids (TRACK). The TRACK is a 5-item measure assessing asthma symptoms and control in young children by caregiver report. Items assessing frequency of various asthma-related events (e.g., breathing problems, quick-relief medication use, etc.) are rated on a Likert-type scale from Not at all (scored 20) to Extremely (scored 0). Scores &lt; 80 suggest child's asthma is not well controlled.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Child Asthma Control (Individual Level, ages 5-11 years)</measure>
      <time_frame>Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.</time_frame>
      <description>Effectiveness of the intervention on child-level asthma control is measured using the Childhood Asthma Control Test (cACT). Children answer 4 questions on a 0-3 scale, and caregivers answer 3 questions on a 0-5 scale related to the frequency child's asthma symptoms in the previous 4 weeks. Lower scores indicate worse symptoms. Scores of 19 or less suggest asthma is not well controlled.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Child Asthma Control (Individual Level; ages 12 and up)</measure>
      <time_frame>Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.</time_frame>
      <description>Effectiveness of the intervention on child-level asthma control is measured using the Asthma Control Test. Youth ages 12 and up complete 5-items related to their asthma on Likert-type scales ranging from 1-5, with lower scores indicating more severe symptoms. A cutoff score &lt;19 indicates suboptimal asthma control; scores &lt;=15 suggest poorly controlled asthma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health Care Utilization-ED visits (Community Level)</measure>
      <time_frame>12 months pre- and post-intervention year</time_frame>
      <description>Health care utilization will be assessed by community-level rates of Emergency Department visits of children within the targeted geographic area. Obtaining utilization rates in this way will help the researchers to assess effectiveness of the intervention on the community level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health Care Utilization-Hospitalizations (Community Level)</measure>
      <time_frame>12 months pre- and post-intervention year</time_frame>
      <description>Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of hospitalizations in children within the targeted geographic area.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health Care Utilization-Urgent Care Visits (Community Level)</measure>
      <time_frame>12 months pre- and post-intervention year</time_frame>
      <description>Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of urgent care visits in children within the targeted geographic area.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Asthma-related Quality of Life (QoL) (Individual Level)</measure>
      <time_frame>Asthma-related QOL will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every three months for 1 year.</time_frame>
      <description>Effectiveness on child-level quality of life (QOL) will be measured by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). The instrument consists of 23 items related to limitation across three domains (activity limitation, symptoms and emotional function). Each item is rated 1-7 on a Likert scale, with lower numerical responses indicating greater impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>School Absences (Community Level)</measure>
      <time_frame>12 months pre- and post-intervention year</time_frame>
      <description>Community-level school absences will be assessed by attendance data (i.e., number of school absences) from the schools in the targeted area that correspond to each &quot;step&quot; in the wedge of the study design.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">480</enrollment>
    <condition>Pediatric Asthma</condition>
    <arm_group>
      <arm_group_label>Low-Intensity (Virtual) Intervention Implementation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>During low intensity implementation, families of children with poorly controlled asthma will be referred to the remote version of HARP (HARP-V) and will receive CASE remotely (CASE-V). Children with not well controlled asthma will receive only CASE-V remotely.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High Intensity (in-Person) Intervention Implementation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>During high intensity implementation, all interventions are administered in person.&#xD;
  Specifically, families of children with poorly controlled asthma will receive in-person versions of HARP and CASE. Children with not well controlled asthma will receive an in-person version of CASE only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CASE in person version (High Intensity Package)</intervention_name>
      <description>Controlling Asthma in Schools Effectively (CASE) is a multi-level school-based asthma management program delivered by a Community Health Worker (CHW) that includes 1) staff training involving education on asthma management in school, 2) child-based asthma management education with an emphasis on control of symptoms in the school setting provided in a group setting during the school day, 3) caregiver education after school involving supporting children's asthma control in the school setting, 4), and provision of an Asthma Action Plan (AAP) to the school for child enrollees.</description>
      <arm_group_label>Low-Intensity (Virtual) Intervention Implementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CASE-V remote version (Low Intensity Package)</intervention_name>
      <description>CASE-V, the low intensity version of CASE, includes similar child and caregiver-based asthma management education that is provided in a remote format with adaptation to integrate technological feature of Zoom. All CASE-V components (for staff, children, and parents) have been adapted to promote engagement (e.g., use of chat and polling function).</description>
      <arm_group_label>Low-Intensity (Virtual) Intervention Implementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CASE and HARP in person (High Intensity package)</intervention_name>
      <description>Children with &quot;poorly controlled&quot; asthma will receive both the CASE and HARP programs. HARP is a home-visiting program that includes individualized asthma management education and strategies and supplies for environmental remediation. All 3 visits can be conducted by a CHW. The first includes a &quot;walk-through&quot; to identify triggers. Asthma education and self-management strategies are provided using a structured protocol and low-literacy flip-book (English or Spanish). Referrals and advocacy are offered to address asthma management barriers (e.g., communication with landlord/housing re: code violation). The 2nd and 3rd visits include delivery of supplies (e.g., HEPA vacuum, pest gels, mattress covers), instruction for use, review of AAP, and follow-up on environmental control recommendations provided during the 1st visit.</description>
      <arm_group_label>High Intensity (in-Person) Intervention Implementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CASE-V and HARP-V remote version (Low Intensity package)</intervention_name>
      <description>HARP-V replicates the content delivered in HARP in a remote format. The first session includes a virtual &quot;walk-through&quot; in which the educator uses a structured script and checklist to guide the caregiver through the home and show specific components of the environment (e.g., carpeting, area under the kitchen sink, exhaust fan in bathroom) to identify asthma triggers. Asthma education and self-management strategies are provided using a structured protocol and slide overview based on the HARP flip-book. Supplies for environmental remediation are delivered prior to the 2nd visit. The 2nd and 3rd visit include instruction for use of supplies, review of AAP, and follow-up on recommendations and referrals.</description>
      <arm_group_label>High Intensity (in-Person) Intervention Implementation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Children between the ages of 2 and 12 years old&#xD;
  &#xD;
            2. Children must reside in one of the identified catchment areas&#xD;
  &#xD;
            3. Children must meet the screening criteria as having not well controlled or poorly&#xD;
               controlled asthma&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. Children with complex medical conditions&#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>Daphne Koinis Mitchell, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rhode Island Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Elizabeth L McQuaid, PhD, ABPP</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rhode Island Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ligia Chavez, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Puerto Rico</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Glorisa Canino, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Puerto Rico</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Rhode Island Hospital</name>
        <address>
          <city>Providence</city>
          <state>Rhode Island</state>
          <zip>02903</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Medial Sciences Campus, University of Puerto Rico</name>
        <address>
          <city>San Juan</city>
          <zip>00937</zip>
          <country>Puerto Rico</country>
        </address>
      </facility>
      <contact>
        <last_name>Ligia Chavez, PhD</last_name>
        <phone>787-758-2525</phone>
        <phone_ext>1941</phone_ext>
        <email>ligia.chavez@upr.edu</email>
      </contact>
      <contact_backup>
        <last_name>Keilyn Vale, MS</last_name>
        <phone>787-758-2525</phone>
        <phone_ext>1994</phone_ext>
        <email>keilyn.vale@upr.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Puerto Rico</country>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.</citation>
      <PMID>30984733</PMID>
    </reference>
    <reference>
      <citation>CFIR Research Team. Strategy Design [Web]. Consolidated Framework for Implementation Research; 2019 [Available from: https://cfirguide.org/choosing-strategies/ accessed 22 November 2019.</citation>
    </reference>
    <reference>
      <citation>Chambers DA, Norton WE. The Adaptome: Advancing the Science of Intervention Adaptation. Am J Prev Med. 2016 Oct;51(4 Suppl 2):S124-31. doi: 10.1016/j.amepre.2016.05.011. Epub 2016 Jun 28.</citation>
      <PMID>27371105</PMID>
    </reference>
    <reference>
      <citation>Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4.</citation>
      <PMID>31036028</PMID>
    </reference>
    <reference>
      <citation>Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.</citation>
      <PMID>19348922</PMID>
    </reference>
    <reference>
      <citation>Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.</citation>
      <PMID>17353040</PMID>
    </reference>
    <reference>
      <citation>Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.</citation>
      <PMID>14713908</PMID>
    </reference>
    <reference>
      <citation>Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in the parents of children with asthma. Qual Life Res. 1996 Feb;5(1):27-34. doi: 10.1007/BF00435966.</citation>
      <PMID>8901364</PMID>
    </reference>
    <verification_date>January 2023</verification_date>
    <study_first_submitted>May 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pediatric asthma</keyword>
    <keyword>Community intervention program</keyword>
    <keyword>Hybrid Type III</keyword>
    <keyword>Effectiveness and implementation</keyword>
    <keyword>Home-based intervention</keyword>
    <keyword>School-based intervention</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>Yes</sharing_ipd>
      <ipd_description>Following the NIH data sharing policy (2015), within one year of completion of the studies and dissemination of primary study results, public-use analysis datasets will be made available to the public, along with the final version of the study protocol, data dictionaries, and brief instructions. De-identification for the analysis datasets will follow published guidelines for &quot;limited access data sets&quot; funded by NHLBI (Geller et al., 2004).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will become available within roughly one year of completion of the studies and dissemination of primary study results and will be available for 10 years following the completion of the study.</ipd_time_frame>
      <ipd_access_criteria>Once they become available, researchers requesting the data would follow the PR-AIR data request procedures. We will make the data available to potential users only under a NIH-approved data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant in any way; (2) a commitment to securing the data using appropriate information security that is compliant with the most recent federal guidelines that are outlined by our information security protocol; and (3)a commitment to destroying or returning the data after analyses are completed.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999032
  org study id: R01HL159701
  nct id: NCT05999032
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to adapt and deliver an evidence-based multi-level intervention
        to reduce asthma disparities, and that promote and improve population health in the
        high-burden communities of San Juan, Puerto Rico.
  
        The Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated
        to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This
        study unfolds in two phases: In Phase 1, the researchers will collaborate with community
        stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2
        consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods
        of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption,
        Implementation, and Maintenance) framework and a mixed methods approach.
  During the formative evaluation (Phase 1), the researchers will engage community stakeholders
        (primary caregivers of children with asthma, school personnel, asthma healthcare providers)
        to help identify, adapt and finalize strategies for PR-AIR implementation. The Consolidated
        Framework for Implementation Research (CFIR) will be used to identify barriers and
        facilitators of low-intensity and high-intensity implementation approaches, the Adaptome to
        guide intervention adaptation to the context of PR, and the CFIR-ERIC matching tool to
        identify strategies to support but low- and high-intensity implementation packages. Fifteen
        stakeholders will complete in-depth interviews early in Phase 1, and 16 will participate in
        two focus groups at the end of Phase 1 prior to the transition to Phase 2, in preparation for
        trial implementation. A collaborative of community stakeholders will be convened (the PR-AIR
        CC) to provide input throughout both phases of the trial.
  
        In Phase 2 (Years 2-4) 480 urban children will be enrolled, ages 2-12 (expected retention for
        full protocol, n = 400) with asthma across 12 areas in San Juan with high asthma burden.
        Randomization is at the level of targeted geographic area, and data will be collected from
        groups in each of these areas over time. Individual-level (asthma control, QOL) and
        community-specific (ED use/hospitalizations, school absence) effectiveness outcomes will be
        evaluated. All families will participate in both a control (in our case, baseline period for
        the community indicators) and intervention (active trial). Each target area will begin with a
        low-intensity (virtual) implementation phase, and transition to a high-intensity
        implementation phase mid-year. Families enrolled in the first 5 months of the school year
        will receive the low-intensity intervention package, and those enrolled in the last 5 months
        of the school year will receive the high-intensity intervention package. Input will be
        collected throughout each year from community stakeholders about the trial, through in-depth
        interviews and surveys. Reach, Adoption, Implementation, and Maintenance will be measured
        using a mixed-methods approach at the end of each trial year (years 2 - 4). Repeated
        assessments will measure individual-level effectiveness outcomes (asthma control, QOL) at
        time points linked to the start of intervention participation; at enrollment, end of
        treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every
        3 months for 1 year.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Child Asthma Control (Individual Level, ages 2-4 years)
  time frame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
  description: Effectiveness of the intervention on child-level asthma control is measured using the Test for Respiratory and Asthma Control in Kids (TRACK). The TRACK is a 5-item measure assessing asthma symptoms and control in young children by caregiver report. Items assessing frequency of various asthma-related events (e.g., breathing problems, quick-relief medication use, etc.) are rated on a Likert-type scale from Not at all (scored 20) to Extremely (scored 0). Scores < 80 suggest child's asthma is not well controlled.
  measure: Change in Child Asthma Control (Individual Level, ages 5-11 years)
  time frame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
  description: Effectiveness of the intervention on child-level asthma control is measured using the Childhood Asthma Control Test (cACT). Children answer 4 questions on a 0-3 scale, and caregivers answer 3 questions on a 0-5 scale related to the frequency child's asthma symptoms in the previous 4 weeks. Lower scores indicate worse symptoms. Scores of 19 or less suggest asthma is not well controlled.
  measure: Change in Child Asthma Control (Individual Level; ages 12 and up)
  time frame: Asthma Control will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every 3 months for 1 year.
  description: Effectiveness of the intervention on child-level asthma control is measured using the Asthma Control Test. Youth ages 12 and up complete 5-items related to their asthma on Likert-type scales ranging from 1-5, with lower scores indicating more severe symptoms. A cutoff score <19 indicates suboptimal asthma control; scores <=15 suggest poorly controlled asthma.
  measure: Health Care Utilization-ED visits (Community Level)
  time frame: 12 months pre- and post-intervention year
  description: Health care utilization will be assessed by community-level rates of Emergency Department visits of children within the targeted geographic area. Obtaining utilization rates in this way will help the researchers to assess effectiveness of the intervention on the community level.
  measure: Health Care Utilization-Hospitalizations (Community Level)
  time frame: 12 months pre- and post-intervention year
  description: Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of hospitalizations in children within the targeted geographic area.
  measure: Health Care Utilization-Urgent Care Visits (Community Level)
  time frame: 12 months pre- and post-intervention year
  description: Effectiveness of the intervention on the community level. Health care utilization will be assessed by community-level rates of urgent care visits in children within the targeted geographic area.
  measure: Asthma-related Quality of Life (QoL) (Individual Level)
  time frame: Asthma-related QOL will be measured at baseline, End of Treatment (EOT; 1 - 2 months after baseline, depending on intervention assignment), and every three months for 1 year.
  description: Effectiveness on child-level quality of life (QOL) will be measured by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). The instrument consists of 23 items related to limitation across three domains (activity limitation, symptoms and emotional function). Each item is rated 1-7 on a Likert scale, with lower numerical responses indicating greater impairment.
  measure: School Absences (Community Level)
  time frame: 12 months pre- and post-intervention year
  description: Community-level school absences will be assessed by attendance data (i.e., number of school absences) from the schools in the targeted area that correspond to each "step" in the wedge of the study design.
  arm group label: Low-Intensity (Virtual) Intervention Implementation
  arm group type: Active Comparator
  description: During low intensity implementation, families of children with poorly controlled asthma will be referred to the remote version of HARP (HARP-V) and will receive CASE remotely (CASE-V). Children with not well controlled asthma will receive only CASE-V remotely.
  arm group label: High Intensity (in-Person) Intervention Implementation
  arm group type: Active Comparator
  description: During high intensity implementation, all interventions are administered in person.
  Specifically, families of children with poorly controlled asthma will receive in-person versions of HARP and CASE. Children with not well controlled asthma will receive an in-person version of CASE only.
  intervention type: Behavioral
  intervention name: CASE in person version (High Intensity Package)
  description: Controlling Asthma in Schools Effectively (CASE) is a multi-level school-based asthma management program delivered by a Community Health Worker (CHW) that includes 1) staff training involving education on asthma management in school, 2) child-based asthma management education with an emphasis on control of symptoms in the school setting provided in a group setting during the school day, 3) caregiver education after school involving supporting children's asthma control in the school setting, 4), and provision of an Asthma Action Plan (AAP) to the school for child enrollees.
  arm group label: Low-Intensity (Virtual) Intervention Implementation
  intervention type: Behavioral
  intervention name: CASE-V remote version (Low Intensity Package)
  description: CASE-V, the low intensity version of CASE, includes similar child and caregiver-based asthma management education that is provided in a remote format with adaptation to integrate technological feature of Zoom. All CASE-V components (for staff, children, and parents) have been adapted to promote engagement (e.g., use of chat and polling function).
  arm group label: Low-Intensity (Virtual) Intervention Implementation
  intervention type: Behavioral
  intervention name: CASE and HARP in person (High Intensity package)
  description: Children with "poorly controlled" asthma will receive both the CASE and HARP programs. HARP is a home-visiting program that includes individualized asthma management education and strategies and supplies for environmental remediation. All 3 visits can be conducted by a CHW. The first includes a "walk-through" to identify triggers. Asthma education and self-management strategies are provided using a structured protocol and low-literacy flip-book (English or Spanish). Referrals and advocacy are offered to address asthma management barriers (e.g., communication with landlord/housing re: code violation). The 2nd and 3rd visits include delivery of supplies (e.g., HEPA vacuum, pest gels, mattress covers), instruction for use, review of AAP, and follow-up on environmental control recommendations provided during the 1st visit.
  arm group label: High Intensity (in-Person) Intervention Implementation
  intervention type: Behavioral
  intervention name: CASE-V and HARP-V remote version (Low Intensity package)
  description: HARP-V replicates the content delivered in HARP in a remote format. The first session includes a virtual "walk-through" in which the educator uses a structured script and checklist to guide the caregiver through the home and show specific components of the environment (e.g., carpeting, area under the kitchen sink, exhaust fan in bathroom) to identify asthma triggers. Asthma education and self-management strategies are provided using a structured protocol and slide overview based on the HARP flip-book. Supplies for environmental remediation are delivered prior to the 2nd visit. The 2nd and 3rd visit include instruction for use of supplies, review of AAP, and follow-up on recommendations and referrals.
  arm group label: High Intensity (in-Person) Intervention Implementation
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Daphne Koinis Mitchell, PhD
  role: Principal Investigator
  affiliation: Rhode Island Hospital
  last name: Elizabeth L McQuaid, PhD, ABPP
  role: Principal Investigator
  affiliation: Rhode Island Hospital
  last name: Ligia Chavez, PhD
  role: Principal Investigator
  affiliation: University of Puerto Rico
  last name: Glorisa Canino, PhD
  role: Principal Investigator
  affiliation: University of Puerto Rico
  facility: 
  facility: 
  contact: 
  contact backup: 
  country: Puerto Rico
  country: United States
  citation: Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
  PMID: 30984733
  citation: CFIR Research Team. Strategy Design [Web]. Consolidated Framework for Implementation Research; 2019 [Available from: https://cfirguide.org/choosing-strategies/ accessed 22 November 2019.
  citation: Chambers DA, Norton WE. The Adaptome: Advancing the Science of Intervention Adaptation. Am J Prev Med. 2016 Oct;51(4 Suppl 2):S124-31. doi: 10.1016/j.amepre.2016.05.011. Epub 2016 Jun 28.
  PMID: 27371105
  citation: Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4.
  PMID: 31036028
  citation: Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.
  PMID: 19348922
  citation: Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
  PMID: 17353040
  citation: Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
  PMID: 14713908
  citation: Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in the parents of children with asthma. Qual Life Res. 1996 Feb;5(1):27-34. doi: 10.1007/BF00435966.
  PMID: 8901364
  responsible party type: Sponsor
  mesh term: Asthma
  sharing ipd: Yes
  ipd description: Following the NIH data sharing policy (2015), within one year of completion of the studies and dissemination of primary study results, public-use analysis datasets will be made available to the public, along with the final version of the study protocol, data dictionaries, and brief instructions. De-identification for the analysis datasets will follow published guidelines for "limited access data sets" funded by NHLBI (Geller et al., 2004).
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Data will become available within roughly one year of completion of the studies and dissemination of primary study results and will be available for 10 years following the completion of the study.
  ipd access criteria: Once they become available, researchers requesting the data would follow the PR-AIR data request procedures. We will make the data available to potential users only under a NIH-approved data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant in any way; (2) a commitment to securing the data using appropriate information security that is compliant with the most recent federal guidelines that are outlined by our information security protocol; and (3)a commitment to destroying or returning the data after analyses are completed.