<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/NCT02256397</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-14-0380</org_study_id>
    <secondary_id>UL1TR000371</secondary_id>
    <secondary_id>KL2TR000370</secondary_id>
    <nct_id>NCT02256397</nct_id>
  </id_info>
  <brief_title>Home Centered Comprehensive Care (HCCC) for Children With Asthma</brief_title>
  <acronym>HCCC</acronym>
  <official_title>Home-Centered Comprehensive Care (HCCC) for Children With Severe Asthma: A Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Medicare and Medicaid Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess whether comprehensive care enhanced with new&#xD;
      technology to optimize asthma care in the home (using both a special sensor to track inhaler&#xD;
      use and a hand-held PIKO-1 device to assess patients' forced expiratory volume in the 1st&#xD;
      second [FEV1]) is effective in reducing total days when medical treatment is given outside&#xD;
      the home (in clinic, emergency department, or hospital) among children with severe asthma&#xD;
      receiving comprehensive care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND INFORMATION&#xD;
&#xD;
      Asthma is the most common pediatric chronic disease. Despite the understanding of its&#xD;
      pathophysiology and the availability of effective therapies, adverse effects on health,&#xD;
      school attendance, academic achievement, and family life remain high, particularly among&#xD;
      children with severe asthma in minority or low income families.&#xD;
&#xD;
      Innovative new approaches are needed. One innovation that have shown to be cost-effective in&#xD;
      high-risk chronically ill children, including children with severe asthma, is care in an&#xD;
      enhanced medical home, our High-Risk Comprehensive Care (HRCC) which was designed to optimize&#xD;
      care in medical settings. The innovation to be pilot-tested in the proposed research is&#xD;
      Home-Centered Comprehensive Care (HCCC) designed to also optimize care in the home and&#xD;
      thereby reduce clinic visits and school absences and further decrease Emergency Department&#xD;
      visits and hospital days. The proposed HCCC trial builds on the infrastructure, cell phone&#xD;
      access to the child's primary caregivers at any hour, and improved outcomes established in&#xD;
      our previous HRCC trial (clinicaltrials.gov Identifier: NCT02128776.&#xD;
&#xD;
      DESIGN&#xD;
&#xD;
      Pilot trial of 80 children (2-18 years of age) with uncontrolled severe asthma randomized to&#xD;
      either:&#xD;
&#xD;
        -  High-Risk Comprehensive Care (HRCC) that includes 24/7 cell phone access to skilled&#xD;
           caregivers, same day care for acute illness Monday through Friday, subspecialty care&#xD;
           available in the same facility, and identification each weekday of all children having&#xD;
           ED visits and hospitalizations to assure prompt follow-up and coordination of care; or&#xD;
&#xD;
        -  Home-Centered Comprehensive Care (HCCC) that will also include: 1) monitoring and&#xD;
           augmenting treatment adherence using a special sensor to track inhaler use and identify&#xD;
           inadequate or excessive medication; 2) using a simple hand-held PIKO-1 device to assess&#xD;
           and transmit to caregivers the 1-second forced expiratory volume, allowing caregivers to&#xD;
           better assist the parents and to make better treatment decisions and gauge response at&#xD;
           any hour.&#xD;
&#xD;
      HYPOTHESES&#xD;
&#xD;
      HCCC will be associated with:&#xD;
&#xD;
        1. A &gt;40% reduction in treatment days outside the home (in a clinic, ED visits or hospital)&#xD;
           per child-year from enrollment to the end of the trial (primary hypothesis);&#xD;
&#xD;
        2. A decrease in school absences with respiratory problems to &lt;5 d per school year;&#xD;
&#xD;
        3. An increase in FEV1&gt;12% in routine pulmonary function tests in our clinic at 12 mo.&#xD;
           after enrollment;&#xD;
&#xD;
        4. Increased maternal satisfaction on the Consumer Assessment of Healthcare Providers and&#xD;
           Systems Survey;&#xD;
&#xD;
        5. Reduced or low net health system costs relative to that reported for common treatment&#xD;
           methods for asthma (expressed as health system cost per clinic visit, ED visit,&#xD;
           hospitalization, or school absence prevented);&#xD;
&#xD;
        6. Reduced Medicaid costs (due to lower reimbursements for clinic, ED, and hospital care);&#xD;
&#xD;
        7. An increase in medical school costs relative to reimbursements that will be lower than&#xD;
           the savings to Medicaid (due to its reduction in reimbursements). Such a difference will&#xD;
           be important in efforts to promote adequate reimbursements for such care to the medical&#xD;
           school&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
      1.To randomize 80 eligible children to either standard HRCC or to HCCC in addition to HRCC in&#xD;
      a pilot trial and evaluate whether the augmentation of the HCCC program will:&#xD;
&#xD;
        1. reduce total days when medical treatment is given outside the home (in a clinic, ED, or&#xD;
           hospital);&#xD;
&#xD;
        2. reduce days of school missed with respiratory illnesses (including respiratory&#xD;
           infections with symptoms aggravated by asthma);&#xD;
&#xD;
        3. improve routine pulmonary function tests one year after enrollment;&#xD;
&#xD;
        4. augment maternal satisfaction of care above even the high current levels for CC;&#xD;
&#xD;
        5. reduce costs from a health system perspective and government (Medicaid) perspective&#xD;
&#xD;
        6. increase costs relative to reimbursements from the provider (medical school) perspective&#xD;
&#xD;
      STUDY DESIGN:&#xD;
&#xD;
      Pilot trial of 80 severe asthmatics attending the HRCC that includes 24/7 cell phone access&#xD;
      to skilled primary caregivers or to HRCC with the addition of HCCC that will also include: 1)&#xD;
      monitoring and augmenting treatment adherence using a special sensor to track inhaler use and&#xD;
      identify inadequate or excessive medication; 2) using a simple hand-held PIKO-1 device to&#xD;
      assess and transmit to caregivers the 1-second forced expiratory volume, allowing caregivers&#xD;
      to better assist the parents and to make better treatment decisions and gauge response at any&#xD;
      hour.&#xD;
&#xD;
      The pilot trial will have duration of 2 years. We will measure efficacy based on increase&#xD;
      FEV1 in routine pulmonary function test, reduced total days spent in clinics, Emergency&#xD;
      departments and hospital, and well as reduced total days of school missed due to pulmonary&#xD;
      illness. Safety will be assessed by looking at any unexpected adverse events.&#xD;
&#xD;
      With parental consent, we can also augment our care through use of Linked In to visualize the&#xD;
      child and assess his/her condition. We recently surveyed our asthma patients given CC and to&#xD;
      our surprise found that 75% (30/42) have access to &quot;Linked in&quot; on their home computer or&#xD;
      smart phone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medical treatment outside of home</measure>
    <time_frame>2 years</time_frame>
    <description>Total number of days when medical treatment was given outside the home (in a clinic, ED, or hospital).&#xD;
Measured by parent report every 3 months for both groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Days of missed school</measure>
    <time_frame>2 years</time_frame>
    <description>Total number of days of school missed with respiratory illnesses (including respiratory infections with symptoms aggravated by asthma).&#xD;
Measured by parental report on questionnaires given every 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Function Tests. (PFTs)</measure>
    <time_frame>2 years</time_frame>
    <description>Improve routine pulmonary function tests one year after enrollment by measuring PFTs during every clinic visit (for both groups), and by hand-held PFT device (PiKo-only for intervention group)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Satisfaction</measure>
    <time_frame>2 years</time_frame>
    <description>Parental satisfaction among groups using CAHPS survey annually.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total costs of clinic and hospital care</measure>
    <time_frame>2 years</time_frame>
    <description>Total cost of clinic and hospital cost measured using billing information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Services Cost to Reimbursement</measure>
    <time_frame>2 years</time_frame>
    <description>Physician Services cost to reimbursement measured using UT claims data.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Standard comprehensive care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard comprehensive care at High Risk Children's Clinic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced comprehensive care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>standard comprehensive care at the High Risk Children's Clinic enhaced with new technologies:&#xD;
If between 2 and 5 years old--&gt; will receive Home-centered comprehensive care with the propeller&#xD;
5 and above--&gt; will receive home-centered comprehensive care with propeller and PIKO</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard comprehensive care</intervention_name>
    <description>Standard comprehensive care at High Risk Children's Clinic</description>
    <arm_group_label>Enhanced comprehensive care</arm_group_label>
    <arm_group_label>Standard comprehensive care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>enhanced comprehensive care</intervention_name>
    <description>standard comprehensive care at the High Risk Children's Clinic enhaced with new technologies:&#xD;
If between 2 and 5 years old--&gt; will receive Home-centered comprehensive care with the propeller&#xD;
5 and above--&gt; will receive home-centered comprehensive care with propeller and PIKO</description>
    <arm_group_label>Enhanced comprehensive care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with severe asthma (poorly controlled by NIH guidelines ) who meet the&#xD;
             inclusion criteria for HRCC (&gt;3 ED visits, &gt;2 hospitalizations, or &gt;1 pediatric ICU&#xD;
             admission in past as well as a &gt;50% estimated risk of hospitalization in next yr).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other major lung disease (e.g. cystic fibrosis or bronchopulmonary dysplasia) or&#xD;
             neuromuscular impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo A Mosquera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Medical School in Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>High Risk Children's Clinic</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>May 3, 2017</last_update_submitted>
  <last_update_submitted_qc>May 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Ricardo A. Mosquera</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Asthma</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/NCT02256397
org study id: HSC-MS-14-0380
secondary id: UL1TR000371
secondary id: KL2TR000370
nct id: NCT02256397
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to assess whether comprehensive care enhanced with new
      technology to optimize asthma care in the home (using both a special sensor to track inhaler
      use and a hand-held PIKO-1 device to assess patients' forced expiratory volume in the 1st
      second [FEV1]) is effective in reducing total days when medical treatment is given outside
      the home (in clinic, emergency department, or hospital) among children with severe asthma
      receiving comprehensive care.
BACKGROUND INFORMATION

      Asthma is the most common pediatric chronic disease. Despite the understanding of its
      pathophysiology and the availability of effective therapies, adverse effects on health,
      school attendance, academic achievement, and family life remain high, particularly among
      children with severe asthma in minority or low income families.

      Innovative new approaches are needed. One innovation that have shown to be cost-effective in
      high-risk chronically ill children, including children with severe asthma, is care in an
      enhanced medical home, our High-Risk Comprehensive Care (HRCC) which was designed to optimize
      care in medical settings. The innovation to be pilot-tested in the proposed research is
      Home-Centered Comprehensive Care (HCCC) designed to also optimize care in the home and
      thereby reduce clinic visits and school absences and further decrease Emergency Department
      visits and hospital days. The proposed HCCC trial builds on the infrastructure, cell phone
      access to the child's primary caregivers at any hour, and improved outcomes established in
      our previous HRCC trial (clinicaltrials.gov Identifier: NCT02128776.

      DESIGN

      Pilot trial of 80 children (2-18 years of age) with uncontrolled severe asthma randomized to
      either:

        -  High-Risk Comprehensive Care (HRCC) that includes 24/7 cell phone access to skilled
           caregivers, same day care for acute illness Monday through Friday, subspecialty care
           available in the same facility, and identification each weekday of all children having
           ED visits and hospitalizations to assure prompt follow-up and coordination of care; or

        -  Home-Centered Comprehensive Care (HCCC) that will also include: 1) monitoring and
           augmenting treatment adherence using a special sensor to track inhaler use and identify
           inadequate or excessive medication; 2) using a simple hand-held PIKO-1 device to assess
           and transmit to caregivers the 1-second forced expiratory volume, allowing caregivers to
           better assist the parents and to make better treatment decisions and gauge response at
           any hour.

      HYPOTHESES

      HCCC will be associated with:

        1. A >40% reduction in treatment days outside the home (in a clinic, ED visits or hospital)
           per child-year from enrollment to the end of the trial (primary hypothesis);

        2. A decrease in school absences with respiratory problems to <5 d per school year;

        3. An increase in FEV1>12% in routine pulmonary function tests in our clinic at 12 mo.
           after enrollment;

        4. Increased maternal satisfaction on the Consumer Assessment of Healthcare Providers and
           Systems Survey;

        5. Reduced or low net health system costs relative to that reported for common treatment
           methods for asthma (expressed as health system cost per clinic visit, ED visit,
           hospitalization, or school absence prevented);

        6. Reduced Medicaid costs (due to lower reimbursements for clinic, ED, and hospital care);

        7. An increase in medical school costs relative to reimbursements that will be lower than
           the savings to Medicaid (due to its reduction in reimbursements). Such a difference will
           be important in efforts to promote adequate reimbursements for such care to the medical
           school

      OBJECTIVES:

      1.To randomize 80 eligible children to either standard HRCC or to HCCC in addition to HRCC in
      a pilot trial and evaluate whether the augmentation of the HCCC program will:

        1. reduce total days when medical treatment is given outside the home (in a clinic, ED, or
           hospital);

        2. reduce days of school missed with respiratory illnesses (including respiratory
           infections with symptoms aggravated by asthma);

        3. improve routine pulmonary function tests one year after enrollment;

        4. augment maternal satisfaction of care above even the high current levels for CC;

        5. reduce costs from a health system perspective and government (Medicaid) perspective

        6. increase costs relative to reimbursements from the provider (medical school) perspective

      STUDY DESIGN:

      Pilot trial of 80 severe asthmatics attending the HRCC that includes 24/7 cell phone access
      to skilled primary caregivers or to HRCC with the addition of HCCC that will also include: 1)
      monitoring and augmenting treatment adherence using a special sensor to track inhaler use and
      identify inadequate or excessive medication; 2) using a simple hand-held PIKO-1 device to
      assess and transmit to caregivers the 1-second forced expiratory volume, allowing caregivers
      to better assist the parents and to make better treatment decisions and gauge response at any
      hour.

      The pilot trial will have duration of 2 years. We will measure efficacy based on increase
      FEV1 in routine pulmonary function test, reduced total days spent in clinics, Emergency
      departments and hospital, and well as reduced total days of school missed due to pulmonary
      illness. Safety will be assessed by looking at any unexpected adverse events.

      With parental consent, we can also augment our care through use of Linked In to visualize the
      child and assess his/her condition. We recently surveyed our asthma patients given CC and to
      our surprise found that 75% (30/42) have access to "Linked in" on their home computer or
      smart phone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Medical treatment outside of home
time frame: 2 years
description: Total number of days when medical treatment was given outside the home (in a clinic, ED, or hospital).
Measured by parent report every 3 months for both groups.
measure: Days of missed school
time frame: 2 years
description: Total number of days of school missed with respiratory illnesses (including respiratory infections with symptoms aggravated by asthma).
Measured by parental report on questionnaires given every 3 months
measure: Pulmonary Function Tests. (PFTs)
time frame: 2 years
description: Improve routine pulmonary function tests one year after enrollment by measuring PFTs during every clinic visit (for both groups), and by hand-held PFT device (PiKo-only for intervention group)
measure: Parental Satisfaction
time frame: 2 years
description: Parental satisfaction among groups using CAHPS survey annually.
measure: Total costs of clinic and hospital care
time frame: 2 years
description: Total cost of clinic and hospital cost measured using billing information.
measure: Physician Services Cost to Reimbursement
time frame: 2 years
description: Physician Services cost to reimbursement measured using UT claims data.
arm group label: Standard comprehensive care
arm group type: Active Comparator
description: Standard comprehensive care at High Risk Children's Clinic
arm group label: Enhanced comprehensive care
arm group type: Experimental
description: standard comprehensive care at the High Risk Children's Clinic enhaced with new technologies:
If between 2 and 5 years old--> will receive Home-centered comprehensive care with the propeller
5 and above--> will receive home-centered comprehensive care with propeller and PIKO
intervention type: Other
intervention name: Standard comprehensive care
description: Standard comprehensive care at High Risk Children's Clinic
arm group label: Enhanced comprehensive care
arm group label: Standard comprehensive care
intervention type: Other
intervention name: enhanced comprehensive care
description: standard comprehensive care at the High Risk Children's Clinic enhaced with new technologies:
If between 2 and 5 years old--> will receive Home-centered comprehensive care with the propeller
5 and above--> will receive home-centered comprehensive care with propeller and PIKO
arm group label: Enhanced comprehensive care
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
last name: Ricardo A Mosquera, MD
role: Principal Investigator
affiliation: University of Texas Medical School in Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Ricardo A. Mosquera
investigator title: Assistant Professor of Pediatrics
mesh term: Asthma