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/NCT05972668</url>
    </required_header>
    <id_info>
      <org_study_id>TH-IRB-0016-0038</org_study_id>
      <nct_id>NCT05972668</nct_id>
    </id_info>
    <brief_title>Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)</brief_title>
    <official_title>Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ministry of Science and Technology, Taiwan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Taipei Hospital, Ministry of Health and Welfare</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ministry of Science and Technology, Taiwan</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 goal of this clinical trial is to investigate whether a smartphone app based on the&#xD;
        Global Initiative for Asthma (GINA) guidelines can improve asthma control and quality of&#xD;
        life, and decrease asthma-related costs in children. The main question it to answer whether&#xD;
        this app can improve asthma control, increase the quality of life, and decrease&#xD;
        asthma-related costs.&#xD;
  &#xD;
        Participants in the intervention group downloaded the asthma smartphone app, and followed up&#xD;
        monthly via phone calls and clinic visits, while the control group received reminder calls.&#xD;
        Researchers will compare with the control group to see if the intervention receives more&#xD;
        asthma control improvement.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2017</start_date>
    <completion_date type="Actual">June 1, 2021</completion_date>
    <primary_completion_date type="Actual">June 1, 2021</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>Number of participants both in intervention and control were assessed for the asthma severity change using Global Strategy for Asthma Management and Prevention (GINA) Guideline</measure>
      <time_frame>3 and 6 months evaluation</time_frame>
      <description>The physician diagnoses asthma change at Taipei Hospital</description>
    </primary_outcome>
    <primary_outcome>
      <measure>All participants were assessed for the Asthma Control Test (ACT) change using ACT questionnaire from quality metric incorporated</measure>
      <time_frame>3 and 6 months evaluation</time_frame>
      <description>The physician evaluate ACT change at Taipei Hospital for both group</description>
    </primary_outcome>
    <primary_outcome>
      <measure>All participants were assessed for the change of Quality of life using MiniPAQLQ</measure>
      <time_frame>3 and 6 months evaluation</time_frame>
      <description>Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>All participants were assessed for the Asthma Control Test change using Paediatric Asthma Quality of Life Questionnaire (PAQLQ) questionnaire</measure>
      <time_frame>3 and 6 months evaluation</time_frame>
      <description>The physician evaluate PASS score change at Taipei Hospital for both group</description>
    </primary_outcome>
    <primary_outcome>
      <measure>All participants were assessed for the Peak Expiratory Flow (PEF) change using spirometry</measure>
      <time_frame>3 and 6 months</time_frame>
      <description>The physician evaluate PEF change at Taipei Hospital for both group</description>
    </primary_outcome>
    <primary_outcome>
      <measure>All participants were assessed for the change of asthma cost using direct and indirect costs from national website</measure>
      <time_frame>3 and 6 months</time_frame>
      <description>Researchers access the data from National Health Insurance database</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>All participants were assessed for their age in the baseline using data of birthday information</measure>
      <time_frame>Baseline</time_frame>
      <description>Nurses and or researchers is responsible in filling the data from the patient admission in the Hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All participants were assessed for the total serum IgE (kU/I) change from blood assessment</measure>
      <time_frame>3 and 6 months evaluation</time_frame>
      <description>The researcher and physician record and evaluate the data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All participants were assessed for the comorbidities with atopic dermatitis using the health data record from Hospital and National Health Insurance</measure>
      <time_frame>Baseline</time_frame>
      <description>The researcher and physician record and evaluate the data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All participants were assessed for the comorbidities with allergic rhinitis using the health data record from Hospital and National Health Insurance</measure>
      <time_frame>Baseline</time_frame>
      <description>The researcher and physician record and evaluate the data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All participants were assessed for the family history of atopic disease using the health data record from Hospital and National Health Insurance</measure>
      <time_frame>Baseline</time_frame>
      <description>The researcher and physician record and evaluate the data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All participants were assessed for the systemic steroid dosage (prednisolone, mg), using the health data record from Hospital and National Health Insurance</measure>
      <time_frame>Baseline</time_frame>
      <description>The researcher and physician record and evaluate the data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All participants were assessed for the ICS Dosage (Seretide,mcg), using the health data record from Hospital and National Health Insurance</measure>
      <time_frame>Baseline</time_frame>
      <description>The researcher and physician record and evaluate the data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All participants were assessed for the Anti-leukotriene (montelukast, tab), using the health data record from Hospital and National Health Insurance</measure>
      <time_frame>Baseline</time_frame>
      <description>The researcher and physician record and evaluate the data</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">140</enrollment>
    <condition>Asthma</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention group needs to download the smartphone apps and follow research protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Smartphone Apps</intervention_name>
      <description>The intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aged between 3 and 18 years;&#xD;
  &#xD;
            -  who had access to the smartphone app;&#xD;
  &#xD;
            -  with asthma treatment steps 2-4, requiring regular treatment with controller&#xD;
               medication (for at least 6 months over the past year) according to the GINA&#xD;
               guidelines;&#xD;
  &#xD;
            -  who had at least two clinic or emergency department visits related to asthma in the&#xD;
               previous year.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children who had comorbidities, or other major medical problems, and who did not have&#xD;
               a smartphone or whose caregivers did not have a smartphone were excluded from the&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Taipei Hospital, Ministry of Health and Welfare</name>
        <address>
          <city>Taipei City</city>
          <state>Taipei</state>
          <zip>242</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Taipei Hospital, Ministry of Health and Welfare</investigator_affiliation>
      <investigator_full_name>I-Jen, Wang</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>Smartphone selft-care system</keyword>
    <keyword>asthma control</keyword>
    <keyword>medical cost</keyword>
    <keyword>emergency room visit</keyword>
    <keyword>hospital admission</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>
      <ipd_description>We don not plan to share individual participant data (IPD)</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>February 17, 2017</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT05972668/SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05972668
  org study id: TH-IRB-0016-0038
  nct id: NCT05972668
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to investigate whether a smartphone app based on the
        Global Initiative for Asthma (GINA) guidelines can improve asthma control and quality of
        life, and decrease asthma-related costs in children. The main question it to answer whether
        this app can improve asthma control, increase the quality of life, and decrease
        asthma-related costs.
  
        Participants in the intervention group downloaded the asthma smartphone app, and followed up
        monthly via phone calls and clinic visits, while the control group received reminder calls.
        Researchers will compare with the control group to see if the intervention receives more
        asthma control improvement.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Number of participants both in intervention and control were assessed for the asthma severity change using Global Strategy for Asthma Management and Prevention (GINA) Guideline
  time frame: 3 and 6 months evaluation
  description: The physician diagnoses asthma change at Taipei Hospital
  measure: All participants were assessed for the Asthma Control Test (ACT) change using ACT questionnaire from quality metric incorporated
  time frame: 3 and 6 months evaluation
  description: The physician evaluate ACT change at Taipei Hospital for both group
  measure: All participants were assessed for the change of Quality of life using MiniPAQLQ
  time frame: 3 and 6 months evaluation
  description: Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire
  measure: All participants were assessed for the Asthma Control Test change using Paediatric Asthma Quality of Life Questionnaire (PAQLQ) questionnaire
  time frame: 3 and 6 months evaluation
  description: The physician evaluate PASS score change at Taipei Hospital for both group
  measure: All participants were assessed for the Peak Expiratory Flow (PEF) change using spirometry
  time frame: 3 and 6 months
  description: The physician evaluate PEF change at Taipei Hospital for both group
  measure: All participants were assessed for the change of asthma cost using direct and indirect costs from national website
  time frame: 3 and 6 months
  description: Researchers access the data from National Health Insurance database
  measure: All participants were assessed for their age in the baseline using data of birthday information
  time frame: Baseline
  description: Nurses and or researchers is responsible in filling the data from the patient admission in the Hospital
  measure: All participants were assessed for the total serum IgE (kU/I) change from blood assessment
  time frame: 3 and 6 months evaluation
  description: The researcher and physician record and evaluate the data
  measure: All participants were assessed for the comorbidities with atopic dermatitis using the health data record from Hospital and National Health Insurance
  time frame: Baseline
  description: The researcher and physician record and evaluate the data
  measure: All participants were assessed for the comorbidities with allergic rhinitis using the health data record from Hospital and National Health Insurance
  time frame: Baseline
  description: The researcher and physician record and evaluate the data
  measure: All participants were assessed for the family history of atopic disease using the health data record from Hospital and National Health Insurance
  time frame: Baseline
  description: The researcher and physician record and evaluate the data
  measure: All participants were assessed for the systemic steroid dosage (prednisolone, mg), using the health data record from Hospital and National Health Insurance
  time frame: Baseline
  description: The researcher and physician record and evaluate the data
  measure: All participants were assessed for the ICS Dosage (Seretide,mcg), using the health data record from Hospital and National Health Insurance
  time frame: Baseline
  description: The researcher and physician record and evaluate the data
  measure: All participants were assessed for the Anti-leukotriene (montelukast, tab), using the health data record from Hospital and National Health Insurance
  time frame: Baseline
  description: The researcher and physician record and evaluate the data
  arm group label: Intervention Group
  arm group type: Experimental
  description: Intervention group needs to download the smartphone apps and follow research protocol
  arm group label: Control group
  arm group type: No Intervention
  intervention type: Device
  intervention name: Smartphone Apps
  description: The intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 18 Years
  healthy volunteers: No
  facility: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Taipei Hospital, Ministry of Health and Welfare
  investigator full name: I-Jen, Wang
  investigator title: Clinical Professor
  mesh term: Asthma
  sharing ipd: No
  ipd description: We don not plan to share individual participant data (IPD)
  provided document: 