<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/NCT04401332</url>
  </required_header>
  <id_info>
    <org_study_id>2019-0038</org_study_id>
    <secondary_id>2018P002394</secondary_id>
    <nct_id>NCT04401332</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial of AppS to Home Monitor Your Asthma</brief_title>
  <acronym>ASTHMA</acronym>
  <official_title>Integrating Patient-Reported Outcomes Into Routine Primary Care: Monitoring Asthma Between Visits</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAND</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RAND</source>
  <oversight_info>
    <has_dmc>No</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 objective of this study is to design, implement, and evaluate the impact of an adapted&#xD;
      health information technology(IT)-enabled practice model for asthma symptom monitoring using&#xD;
      patient-reported outcomes (PROs) in a primary care setting. Adults over 18 years of age with&#xD;
      asthma will be recruited at primary care clinics and randomized to either 1) asthma symptom&#xD;
      monitoring via the mobile health (mHealth) app; or 2) usual care. The investigators will&#xD;
      collect data on patient-reported asthma quality of life and asthma-related healthcare&#xD;
      utilization. We will also study barriers and facilitators to implementation of the mHealth&#xD;
      app and health IT-enabled practice model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aims of this study are:&#xD;
&#xD;
        1. Adapt our existing health IT-enabled practice model for asthma symptom monitoring using&#xD;
           PROs to a primary care population. The health IT-enabled practice model is comprised of&#xD;
           the following: an mHealth app that can be installed on patients' smartphones that&#xD;
           integrates into clinical workflow; and an asthma PRO dashboard in the electronic health&#xD;
           record (EHR) for clinicians.&#xD;
&#xD;
        2. Implement the adapted health IT-enabled practice model in 7 primary care community&#xD;
           clinics, identify a cohort of eligible asthma patients to participate, and train&#xD;
           clinicians and clinical staff.&#xD;
&#xD;
        3. Rigorously evaluate the impact of this new health IT-enabled practice model using a&#xD;
           randomized controlled trial study in which we enroll 500 asthma patients (250&#xD;
           intervention, 250 usual care) by primary care clinician. We will measure&#xD;
           patient-reported asthma quality of life and asthma-related healthcare utilization&#xD;
           (defined as urgent care and emergency room visits and hospitalizations) as our primary&#xD;
           and secondary outcomes, respectively. We will use mixed methods to identify barriers and&#xD;
           facilitators to implementation and factors that affect sustainable spread and scale as&#xD;
           per the Non-adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS)&#xD;
           framework.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">April 30, 2023</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma-related patient-reported quality of life</measure>
    <time_frame>6 months from enrollment</time_frame>
    <description>Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Asthma-related patient-reported quality of life</measure>
    <time_frame>12 months from enrollment</time_frame>
    <description>Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma-related healthcare utilization</measure>
    <time_frame>12 months from enrollment</time_frame>
    <description>Asthma-related healthcare utilization, defined as number of urgent care and emergency room visits, and number of hospitalizations.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">445</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mobile health app</intervention_name>
    <description>asthma symptom monitoring via a clinically integrated mobile health (mHealth) app installed on patients' smartphones</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English- or Spanish-speaking&#xD;
&#xD;
          -  18 years of age&#xD;
&#xD;
          -  Regularly uses (most days) a compatible smartphone (iOS or Android)&#xD;
&#xD;
          -  Able to provide consent&#xD;
&#xD;
          -  Seen for primary care within the last 12 months at one of the 7 outpatient primary&#xD;
             care clinics that are part of the Brigham &amp; Women's Hospital (BWH)/ Brigham &amp; Women's&#xD;
             Faulkner Hospital (BWFH) practice-based research network.&#xD;
&#xD;
          -  At least one visit coded for asthma within 12 months prior to screening, including&#xD;
             inpatient, emergency department, urgent care/walk-in, and specialist visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Deemed inappropriate for study, per judgment of the BWH/ BWFH primary care provider&#xD;
&#xD;
          -  Unable to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert S Rudin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RAND</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anuj K Dalal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mass General Brigham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 25, 2023</last_update_submitted>
  <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>patient-reported outcomes (PROs)</keyword>
  <keyword>mobile health (mHealth) apps</keyword>
  <keyword>asthma</keyword>
  <keyword>electronic health record (EHR)</keyword>
  <keyword>health information technology</keyword>
  <keyword>implementation research</keyword>
  <keyword>mobile phone</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/NCT04401332
org study id: 2019-0038
secondary id: 2018P002394
nct id: NCT04401332
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to design, implement, and evaluate the impact of an adapted
      health information technology(IT)-enabled practice model for asthma symptom monitoring using
      patient-reported outcomes (PROs) in a primary care setting. Adults over 18 years of age with
      asthma will be recruited at primary care clinics and randomized to either 1) asthma symptom
      monitoring via the mobile health (mHealth) app; or 2) usual care. The investigators will
      collect data on patient-reported asthma quality of life and asthma-related healthcare
      utilization. We will also study barriers and facilitators to implementation of the mHealth
      app and health IT-enabled practice model.
The specific aims of this study are:

        1. Adapt our existing health IT-enabled practice model for asthma symptom monitoring using
           PROs to a primary care population. The health IT-enabled practice model is comprised of
           the following: an mHealth app that can be installed on patients' smartphones that
           integrates into clinical workflow; and an asthma PRO dashboard in the electronic health
           record (EHR) for clinicians.

        2. Implement the adapted health IT-enabled practice model in 7 primary care community
           clinics, identify a cohort of eligible asthma patients to participate, and train
           clinicians and clinical staff.

        3. Rigorously evaluate the impact of this new health IT-enabled practice model using a
           randomized controlled trial study in which we enroll 500 asthma patients (250
           intervention, 250 usual care) by primary care clinician. We will measure
           patient-reported asthma quality of life and asthma-related healthcare utilization
           (defined as urgent care and emergency room visits and hospitalizations) as our primary
           and secondary outcomes, respectively. We will use mixed methods to identify barriers and
           facilitators to implementation and factors that affect sustainable spread and scale as
           per the Non-adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS)
           framework.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Asthma-related patient-reported quality of life
time frame: 6 months from enrollment
description: Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)
measure: Asthma-related patient-reported quality of life
time frame: 12 months from enrollment
description: Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)
measure: Asthma-related healthcare utilization
time frame: 12 months from enrollment
description: Asthma-related healthcare utilization, defined as number of urgent care and emergency room visits, and number of hospitalizations.
arm group label: Intervention
arm group type: Experimental
arm group label: Usual Care
arm group type: No Intervention
intervention type: Other
intervention name: mobile health app
description: asthma symptom monitoring via a clinically integrated mobile health (mHealth) app installed on patients' smartphones
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert S Rudin, PhD
role: Principal Investigator
affiliation: RAND
last name: Anuj K Dalal, MD
role: Principal Investigator
affiliation: Mass General Brigham
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma