<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/NCT04480242</url>
  </required_header>
  <id_info>
    <org_study_id>ARCA2017</org_study_id>
    <secondary_id>PI15/00449</secondary_id>
    <nct_id>NCT04480242</nct_id>
  </id_info>
  <brief_title>Asthma Research in Children and Adolescents</brief_title>
  <acronym>ARCA</acronym>
  <official_title>Assessment of Children and Adolescents With Asthma: An Observational Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parc de Salut Mar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Parc de Salut Mar</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 purpose of this study is to assess the evolution of disease control, health-related&#xD;
      quality of life, and the risk of severe asthma exacerbations in children and adolescents with&#xD;
      persistent asthma in Spain at short, mid and long-term follow-up. Patient-reported&#xD;
      information in this project is collected by computer assisted telephone interviews (CATI) and&#xD;
      a mobile application (ARCA App).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
        1. To evaluate the asthma control in children and adolescents with persistent asthma, and&#xD;
           its relationship with patient characteristics, treatment and health-related variables&#xD;
           (treatment adherence, inhalation technique, inhaler device, asthma triggers, and smoking&#xD;
           exposure, among others).&#xD;
&#xD;
        2. To assess the health-related quality of life of children and adolescents with persistent&#xD;
           asthma, and its relationship with patient characteristics, treatment and health-related&#xD;
           variables (asthma control, treatment adherence and inhalation technique, inhaler device,&#xD;
           asthma triggers, and smoking exposure, among others).&#xD;
&#xD;
        3. To assess the risk of severe asthma exacerbations in children and adolescents with&#xD;
           persistent asthma and its relationship with patient characteristics, treatment, and&#xD;
           health-related variables (asthma control, treatment adherence and inhalation technique,&#xD;
           inhaler device, health-related quality of life, asthma triggers, and smoking exposure,&#xD;
           among others).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        1. To evaluate the effect of monitoring inhalation techniques on patients' performance&#xD;
           according to recommended actions when using inhalers, and outcomes such as asthma&#xD;
           control, health-related quality of life, and asthma exacerbations.&#xD;
&#xD;
        2. To assess the treatment adherence in children and adolescents with persistent asthma,&#xD;
           and its relationship with other treatment-related factors (inhaler technique, inhaler&#xD;
           device, adherence attitudes, and beliefs about illness, inhaler and exacerbations, among&#xD;
           others).&#xD;
&#xD;
        3. To evaluate health inequalities in children and adolescents with asthma in Spain.&#xD;
&#xD;
      ARCA is a prospective multicenter observational study in children and adolescents with a&#xD;
      clinical diagnosis of persistent asthma. This clinical diagnosis of asthma is defined as the&#xD;
      presence of wheezing three times in the last year that improves with the use of&#xD;
      bronchodilators. Participants are consecutively recruited in outpatient pediatric pulmonology&#xD;
      hospital consultations and primary care physicians.&#xD;
&#xD;
      Patient-reported information is obtained by computer-assisted telephone interviews (CATI) and&#xD;
      a mobile application (ARCA App). Telephone interviews are performed by trained interviewers&#xD;
      to children 8-16 years old and parents/caregivers of children 6-7 years of age, immediately&#xD;
      after recruitment and every 6 months. It includes the evaluation of asthma control,&#xD;
      prescribed asthma treatment, adherence, and severe asthma exacerbations. Information about&#xD;
      inhalation techniques, socioeconomic status, smoking exposure, triggers, use of peak flow,&#xD;
      symptom diary, perceived asthma care, adherence attitudes, and beliefs about illness, inhaler&#xD;
      and exacerbations is also collected.&#xD;
&#xD;
      The 'ARCA app' combines 3 age versions: parents/guardians (proxy response) for children 6-7&#xD;
      years old, children aged 8-11 years (self-response), and adolescents aged 12-16 years&#xD;
      (self-response). The application consists in an interactive chat, simulating a conversation&#xD;
      by Short Message Service (SMS) or Instant Messaging Application (WhatsApp) with someone in&#xD;
      real time. It includes the monthly administration of 2 questions (global rating of change and&#xD;
      severe asthma exacerbations). At the beginning, after downloading the app, and every two&#xD;
      months different standardized questionnaires are administered by turns: the EuroQol (EQ-5D),&#xD;
      the Pediatric Asthma Impact Scale (PAIS), inhalation techniques scale, and environment&#xD;
      support. These latter scales are administered randomly to two groups of equal size, defined&#xD;
      within the subsample recruited by each pediatrician.&#xD;
&#xD;
      All the information that each participant answers through the app can be viewed by the&#xD;
      pediatrician through a specific platform. The results of the different questionnaires are&#xD;
      shown in charts reflecting the patient's answers over time, using the traffic lights code:&#xD;
      green for good outcomes, amber for intermediate, and red for poor. Clinical data is&#xD;
      registered at recruitment and annually during the follow-up.&#xD;
&#xD;
      Sample size: To detect differences between two groups in the Asthma Control Questionnaire&#xD;
      score of 0.3 SD, 175 patients per group would be required to have a statistical power of 80%,&#xD;
      at a significance level of 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Change from baseline in symptoms control, measured with the Asthma Control Questionnaire (ACQ)</measure>
    <time_frame>2, 5, 7 and 10 years after inclusion</time_frame>
    <description>Symptoms control is measured with the Asthma Control Questionnaire (ACQ-symptoms) only, which assesses the frequency of 5 asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, and wheeze) during the previous week on a 7-point Likert scale from 0 (no impairment) to 6 (maximum impairment). The overall score, calculated as the mean of item responses, ranges from 0 to 6. A score &gt;1.5 is considered not well-controlled asthma, and scores &lt;0.75 well-controlled asthma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Health-Related Quality of Life, measured with the EuroQol</measure>
    <time_frame>2, 5, 7 and 10 years after downloading the ARCA app</time_frame>
    <description>The EQ-5D consists of 5 dimensions (&quot;mobility&quot;, &quot;looking after myself&quot;, &quot;doing usual activities&quot;, &quot;having pain/discomfort&quot; and &quot;feeling worried/sad/unhappy). It includes also a visual analogue scale (EQ-VAS) on the general health status from 0 (worst health status) to 100 (best health status possible). The EQ-5D index ranges from 1 (best health state) to negative values (health states valued as worse than death), where 0 is equal to death, allowing the calculation of Quality-Adjusted Life-Years (QALYs).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of severe asthmatic exacerbations</measure>
    <time_frame>5 and 10 years after inclusion</time_frame>
    <description>As a screening to detect asthma exacerbation, the experience of asthma worsening question is administered through the ARCA app: &quot;In the last month, have you had to take any pill, syrup, oral solution or go to the doctor or hospital, due to asthma worsening?&quot; (Yes/No). If the answer is &quot;yes&quot;, a phone call confirms or discards a severe asthma exacerbation through the following questions: &quot;Did you visit or phone your general practitioner, out-of-hours, or walk-in center because your asthma got worse?&quot;, &quot;Did you call an ambulance or go to the hospital because of your asthma?&quot;, &quot;Did you take steroids tablets (such as Prednisolone or Deltacortril) for at least 2 days because of your asthma?&quot; If the participant answers &quot;yes&quot; to at least one of the 3 questions, an asthma exacerbation is confirmed. These questions were constructed applying the definition of the American Thoracic Society and the European Respiratory Society.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in adherence to the treatment, measured with the Medication Intake Survey adherence scale-Asthma (MIS-A)</measure>
    <time_frame>2, 5, 7 and 10 years after inclusion</time_frame>
    <description>Adherence is assessed separately for each controller inhaler, based on self-reported prescription start date, daily dosage recommendations and 3 questions on controller use over increasing time periods (day before, previous week, and previous month). Percentages of medication used versus prescribed are calculated first for each question, and subsequently as composite scores (0-100). The total score is categorized into complete (100%), intermediate, and low (50%) adherence. Medication abuse (temporary occasional) is also evaluated for each treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in quality of the inhaler technique, measured with the Inhalation Technique Scale</measure>
    <time_frame>2, 5, 7 and 10 years after downloading the ARCA app</time_frame>
    <description>The Inhalation Technique Scale includes five questions on how often participants perform recommended actions when using inhalers, on a 5-point Likert scale from 0 (never) to 4 (always). The overall score, calculated as the mean of items responses, ranges from 0 to 4 points. Higher values indicate better inhaler technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Pediatric Asthma Impact Scale (PAIS)</measure>
    <time_frame>2, 5, 7 and 10 years after downloading the ARCA app</time_frame>
    <description>The Patient-Reported Outcomes Measurement Information System (PROMIS) developed the short version of the Pediatric Asthma Impact Scale (PAIS), composed of 8 items assessing the past seven days in a 5-point response scale with the options: never, almost never, sometimes, often, and almost always. The total raw score (adding the values of the response to each question) is translated into a T-score with a mean of 50 and a standard deviation (SD) of 10. A score lower than 50 is one SD lower than the mean of the reference population.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">525</enrollment>
  <condition>Persistent Asthma</condition>
  <condition>Asthma in Children</condition>
  <condition>Asthma Exacerbation</condition>
  <arm_group>
    <arm_group_label>Asthma Research in Children and Adolescents - Spanish Cohort</arm_group_label>
    <description>Groups defined according to treatments prescribed during regular clinical practice and to the exposure to inhalation techniques monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inhaled Corticosteroids (ICs)</intervention_name>
    <description>Any corticosteroid (beclomethasone, budesonide, ciclesonide, fluticasone propionate, fluticasone furoate, mometasone, and triamcinolone) prescribed by the pediatrician as an inhaled controller medication, for daily management of asthma. The daily dose of ICs prescribed will be translated into beclomethasone equivalent.</description>
    <arm_group_label>Asthma Research in Children and Adolescents - Spanish Cohort</arm_group_label>
    <other_name>Treatments prescribed during regular clinical practice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA)</intervention_name>
    <description>Beclomethasone/formoterol, budesonide/formoterol, fluticasone furoate/vilanterol, fluticasone propionate/formoterol, fluticasone propionate/salmeterol, and mometasone/formoterol. Any of these combinations prescribed by the pediatrician as an inhaled controller medication, for daily management of asthma.</description>
    <arm_group_label>Asthma Research in Children and Adolescents - Spanish Cohort</arm_group_label>
    <other_name>Treatments prescribed during regular clinical practice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other treatments</intervention_name>
    <description>Low-dose oral corticosteroids, long-acting muscarinic antagonist (tiotropium), low-dose macrolides (azithromycin), leukotrienes receptor antagonists (i.e. montelukast), or biologic agents (i.e. omalizumab).</description>
    <arm_group_label>Asthma Research in Children and Adolescents - Spanish Cohort</arm_group_label>
    <other_name>Treatments prescribed during regular clinical practice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inhaler device</intervention_name>
    <description>Pressurized metered-dose inhalers (pMDIs), Breath-actuated pMDIs, Dry powder inhalers (DPIs), Nebulizers, Soft Mist Inhalers.</description>
    <arm_group_label>Asthma Research in Children and Adolescents - Spanish Cohort</arm_group_label>
    <other_name>Treatments prescribed during regular clinical practice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Regularly monitoring of the Inhalation technique through mobile app</intervention_name>
    <description>App users are randomized within each pediatrician into two groups of equal size defined within the subsample recruited, so that 50% of the participants are allocated to answer the inhalation techniques, and the other 50% are allocated to answer the environment support scales. Once the app is downloaded, at month 2 and every 6 months thereafter the intervention group answers the inhalation techniques scale (group 1) and the control group answers the environment support scale (group 2).</description>
    <arm_group_label>Asthma Research in Children and Adolescents - Spanish Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Spanish children and adolescents with persistent asthma seen in the outpatient pediatric&#xD;
        pulmonology clinics and primary care pediatricians.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children or adolescents aged 6-14.&#xD;
&#xD;
          -  Clinical diagnosis of asthma.&#xD;
&#xD;
          -  Undergoing treatment with inhaled corticosteroids (alone or combined with long-acting&#xD;
             beta-agonists) for more than 6 months in the previous year.&#xD;
&#xD;
          -  With access to a smart phone (their own, or their parents').&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant respiratory diseases:&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
&#xD;
          -  Pulmonary fibrosis&#xD;
&#xD;
          -  Bronchiectasis&#xD;
&#xD;
          -  Active tuberculosis,&#xD;
&#xD;
          -  Immunodeficiency associated with alpha 1 antitrypsin deficiency&#xD;
&#xD;
          -  Ciliary diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Montse Ferrer Fores, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parc de Salut Mar</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Montse Ferrer Fores, MD, PhD</last_name>
    <phone>0034933160740</phone>
    <email>mferrer@imim.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centro de Salud de Jerez Sur</name>
      <address>
        <city>Cadiz</city>
        <state>Andalucía</state>
        <zip>11408</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>María Teresa Guerra, MD</last_name>
      <phone>0034639225527</phone>
      <email>guerraperez.mariateresa@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Salud La Candelaria</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucía</state>
        <zip>41006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manuel Praena Crespo, MD</last_name>
      <phone>0034600165496</phone>
      <email>mpraenac@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Torre Ramona</name>
      <address>
        <city>Zaragoza</city>
        <state>Aragón</state>
        <zip>500013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabel Moneo Hernández, MD</last_name>
      <phone>0034976595365</phone>
      <email>isabelmoneoh@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <state>Aragón</state>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José Antonio Castillo Laita, MD</last_name>
      <phone>0034653386213</phone>
      <email>joseacastillolaita@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Dobra</name>
      <address>
        <city>Torrelavega</city>
        <state>Cantabria</state>
        <zip>39300</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alberto Bercedo Sanz, MD</last_name>
      <phone>0034677542466</phone>
      <email>drbercedo@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>María Araceli Caballero, MD</last_name>
      <phone>0034678877673</phone>
      <email>macaballerorabasco@parcdesalutmar.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Atención Primaria de la Vila Olímpica</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08005</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gimena Hernandez Pombo, MD</last_name>
      <phone>0034660214475</phone>
      <email>gimenahernandez@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Inés de Mir Messa, MD</last_name>
      <phone>0034619601782</phone>
      <email>idemir@vhebron.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Parc Taulí</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Valdesoiro, MD</last_name>
      <phone>0034932607722</phone>
      <email>lvaldesoiro@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Segovia</name>
      <address>
        <city>Madrid</city>
        <state>Comunidad De Madrid</state>
        <zip>28005</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>María del Mar Duelo Marcos, MD</last_name>
      <phone>0034676630636</phone>
      <email>mmduelo@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Canillejas</name>
      <address>
        <city>Madrid</city>
        <state>Comunidad De Madrid</state>
        <zip>28022</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olga Cortés Rico, MD</last_name>
      <phone>0034913249595</phone>
      <email>cortesrolga@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Dos de Mayo Móstoles</name>
      <address>
        <city>Madrid</city>
        <state>Comunidad De Madrid</state>
        <zip>28934</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pilar Ortiz Ros, MD</last_name>
      <phone>0034606675877</phone>
      <email>p.ortizros@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro de Salud República de Argentina</name>
      <address>
        <city>Valencia</city>
        <state>Comunidad Valenciana</state>
        <zip>46021</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Carlos Juliá Benito, MD</last_name>
      <phone>00346656792859</phone>
      <email>juancarlosjulia@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Araba</name>
      <address>
        <city>Alava</city>
        <state>País Vasco</state>
        <zip>01009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eva Tato, MD</last_name>
      <phone>0034945007000</phone>
      <email>evatatoeguren@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://arca.imim.es</url>
    <description>Recruitment platform</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04480242
org study id: ARCA2017
secondary id: PI15/00449
nct id: NCT04480242
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the evolution of disease control, health-related
      quality of life, and the risk of severe asthma exacerbations in children and adolescents with
      persistent asthma in Spain at short, mid and long-term follow-up. Patient-reported
      information in this project is collected by computer assisted telephone interviews (CATI) and
      a mobile application (ARCA App).
Primary Objectives:

        1. To evaluate the asthma control in children and adolescents with persistent asthma, and
           its relationship with patient characteristics, treatment and health-related variables
           (treatment adherence, inhalation technique, inhaler device, asthma triggers, and smoking
           exposure, among others).

        2. To assess the health-related quality of life of children and adolescents with persistent
           asthma, and its relationship with patient characteristics, treatment and health-related
           variables (asthma control, treatment adherence and inhalation technique, inhaler device,
           asthma triggers, and smoking exposure, among others).

        3. To assess the risk of severe asthma exacerbations in children and adolescents with
           persistent asthma and its relationship with patient characteristics, treatment, and
           health-related variables (asthma control, treatment adherence and inhalation technique,
           inhaler device, health-related quality of life, asthma triggers, and smoking exposure,
           among others).

      Secondary Objectives:

        1. To evaluate the effect of monitoring inhalation techniques on patients' performance
           according to recommended actions when using inhalers, and outcomes such as asthma
           control, health-related quality of life, and asthma exacerbations.

        2. To assess the treatment adherence in children and adolescents with persistent asthma,
           and its relationship with other treatment-related factors (inhaler technique, inhaler
           device, adherence attitudes, and beliefs about illness, inhaler and exacerbations, among
           others).

        3. To evaluate health inequalities in children and adolescents with asthma in Spain.

      ARCA is a prospective multicenter observational study in children and adolescents with a
      clinical diagnosis of persistent asthma. This clinical diagnosis of asthma is defined as the
      presence of wheezing three times in the last year that improves with the use of
      bronchodilators. Participants are consecutively recruited in outpatient pediatric pulmonology
      hospital consultations and primary care physicians.

      Patient-reported information is obtained by computer-assisted telephone interviews (CATI) and
      a mobile application (ARCA App). Telephone interviews are performed by trained interviewers
      to children 8-16 years old and parents/caregivers of children 6-7 years of age, immediately
      after recruitment and every 6 months. It includes the evaluation of asthma control,
      prescribed asthma treatment, adherence, and severe asthma exacerbations. Information about
      inhalation techniques, socioeconomic status, smoking exposure, triggers, use of peak flow,
      symptom diary, perceived asthma care, adherence attitudes, and beliefs about illness, inhaler
      and exacerbations is also collected.

      The 'ARCA app' combines 3 age versions: parents/guardians (proxy response) for children 6-7
      years old, children aged 8-11 years (self-response), and adolescents aged 12-16 years
      (self-response). The application consists in an interactive chat, simulating a conversation
      by Short Message Service (SMS) or Instant Messaging Application (WhatsApp) with someone in
      real time. It includes the monthly administration of 2 questions (global rating of change and
      severe asthma exacerbations). At the beginning, after downloading the app, and every two
      months different standardized questionnaires are administered by turns: the EuroQol (EQ-5D),
      the Pediatric Asthma Impact Scale (PAIS), inhalation techniques scale, and environment
      support. These latter scales are administered randomly to two groups of equal size, defined
      within the subsample recruited by each pediatrician.

      All the information that each participant answers through the app can be viewed by the
      pediatrician through a specific platform. The results of the different questionnaires are
      shown in charts reflecting the patient's answers over time, using the traffic lights code:
      green for good outcomes, amber for intermediate, and red for poor. Clinical data is
      registered at recruitment and annually during the follow-up.

      Sample size: To detect differences between two groups in the Asthma Control Questionnaire
      score of 0.3 SD, 175 patients per group would be required to have a statistical power of 80%,
      at a significance level of 5%.
observational model: Cohort
time perspective: Prospective
measure: Change from baseline in symptoms control, measured with the Asthma Control Questionnaire (ACQ)
time frame: 2, 5, 7 and 10 years after inclusion
description: Symptoms control is measured with the Asthma Control Questionnaire (ACQ-symptoms) only, which assesses the frequency of 5 asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, and wheeze) during the previous week on a 7-point Likert scale from 0 (no impairment) to 6 (maximum impairment). The overall score, calculated as the mean of item responses, ranges from 0 to 6. A score >1.5 is considered not well-controlled asthma, and scores <0.75 well-controlled asthma.
measure: Change from baseline in Health-Related Quality of Life, measured with the EuroQol
time frame: 2, 5, 7 and 10 years after downloading the ARCA app
description: The EQ-5D consists of 5 dimensions ("mobility", "looking after myself", "doing usual activities", "having pain/discomfort" and "feeling worried/sad/unhappy). It includes also a visual analogue scale (EQ-VAS) on the general health status from 0 (worst health status) to 100 (best health status possible). The EQ-5D index ranges from 1 (best health state) to negative values (health states valued as worse than death), where 0 is equal to death, allowing the calculation of Quality-Adjusted Life-Years (QALYs).
measure: Number of severe asthmatic exacerbations
time frame: 5 and 10 years after inclusion
description: As a screening to detect asthma exacerbation, the experience of asthma worsening question is administered through the ARCA app: "In the last month, have you had to take any pill, syrup, oral solution or go to the doctor or hospital, due to asthma worsening?" (Yes/No). If the answer is "yes", a phone call confirms or discards a severe asthma exacerbation through the following questions: "Did you visit or phone your general practitioner, out-of-hours, or walk-in center because your asthma got worse?", "Did you call an ambulance or go to the hospital because of your asthma?", "Did you take steroids tablets (such as Prednisolone or Deltacortril) for at least 2 days because of your asthma?" If the participant answers "yes" to at least one of the 3 questions, an asthma exacerbation is confirmed. These questions were constructed applying the definition of the American Thoracic Society and the European Respiratory Society.
measure: Change from baseline in adherence to the treatment, measured with the Medication Intake Survey adherence scale-Asthma (MIS-A)
time frame: 2, 5, 7 and 10 years after inclusion
description: Adherence is assessed separately for each controller inhaler, based on self-reported prescription start date, daily dosage recommendations and 3 questions on controller use over increasing time periods (day before, previous week, and previous month). Percentages of medication used versus prescribed are calculated first for each question, and subsequently as composite scores (0-100). The total score is categorized into complete (100%), intermediate, and low (50%) adherence. Medication abuse (temporary occasional) is also evaluated for each treatment.
measure: Change from baseline in quality of the inhaler technique, measured with the Inhalation Technique Scale
time frame: 2, 5, 7 and 10 years after downloading the ARCA app
description: The Inhalation Technique Scale includes five questions on how often participants perform recommended actions when using inhalers, on a 5-point Likert scale from 0 (never) to 4 (always). The overall score, calculated as the mean of items responses, ranges from 0 to 4 points. Higher values indicate better inhaler technique.
measure: Change from baseline in the Pediatric Asthma Impact Scale (PAIS)
time frame: 2, 5, 7 and 10 years after downloading the ARCA app
description: The Patient-Reported Outcomes Measurement Information System (PROMIS) developed the short version of the Pediatric Asthma Impact Scale (PAIS), composed of 8 items assessing the past seven days in a 5-point response scale with the options: never, almost never, sometimes, often, and almost always. The total raw score (adding the values of the response to each question) is translated into a T-score with a mean of 50 and a standard deviation (SD) of 10. A score lower than 50 is one SD lower than the mean of the reference population.
arm group label: Asthma Research in Children and Adolescents - Spanish Cohort
description: Groups defined according to treatments prescribed during regular clinical practice and to the exposure to inhalation techniques monitoring
intervention type: Drug
intervention name: Inhaled Corticosteroids (ICs)
description: Any corticosteroid (beclomethasone, budesonide, ciclesonide, fluticasone propionate, fluticasone furoate, mometasone, and triamcinolone) prescribed by the pediatrician as an inhaled controller medication, for daily management of asthma. The daily dose of ICs prescribed will be translated into beclomethasone equivalent.
arm group label: Asthma Research in Children and Adolescents - Spanish Cohort
other name: Treatments prescribed during regular clinical practice
intervention type: Drug
intervention name: Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA)
description: Beclomethasone/formoterol, budesonide/formoterol, fluticasone furoate/vilanterol, fluticasone propionate/formoterol, fluticasone propionate/salmeterol, and mometasone/formoterol. Any of these combinations prescribed by the pediatrician as an inhaled controller medication, for daily management of asthma.
arm group label: Asthma Research in Children and Adolescents - Spanish Cohort
other name: Treatments prescribed during regular clinical practice
intervention type: Drug
intervention name: Other treatments
description: Low-dose oral corticosteroids, long-acting muscarinic antagonist (tiotropium), low-dose macrolides (azithromycin), leukotrienes receptor antagonists (i.e. montelukast), or biologic agents (i.e. omalizumab).
arm group label: Asthma Research in Children and Adolescents - Spanish Cohort
other name: Treatments prescribed during regular clinical practice
intervention type: Drug
intervention name: Inhaler device
description: Pressurized metered-dose inhalers (pMDIs), Breath-actuated pMDIs, Dry powder inhalers (DPIs), Nebulizers, Soft Mist Inhalers.
arm group label: Asthma Research in Children and Adolescents - Spanish Cohort
other name: Treatments prescribed during regular clinical practice
intervention type: Behavioral
intervention name: Regularly monitoring of the Inhalation technique through mobile app
description: App users are randomized within each pediatrician into two groups of equal size defined within the subsample recruited, so that 50% of the participants are allocated to answer the inhalation techniques, and the other 50% are allocated to answer the environment support scales. Once the app is downloaded, at month 2 and every 6 months thereafter the intervention group answers the inhalation techniques scale (group 1) and the control group answers the environment support scale (group 2).
arm group label: Asthma Research in Children and Adolescents - Spanish Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: No
last name: Montse Ferrer Fores, MD,PhD
role: Principal Investigator
affiliation: Parc de Salut Mar
last name: Montse Ferrer Fores, MD, PhD
phone: 0034933160740
email: mferrer@imim.es
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country: Spain
url: http://arca.imim.es
description: Recruitment platform
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: Undecided