Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
525 participants
OBSERVATIONAL
2017-07-26
2030-12-31
Brief Summary
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Detailed Description
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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%.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Asthma Research in Children and Adolescents - Spanish Cohort
Groups defined according to treatments prescribed during regular clinical practice and to the exposure to inhalation techniques monitoring
Inhaled Corticosteroids (ICs)
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.
Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA)
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.
Other treatments
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).
Inhaler device
Pressurized metered-dose inhalers (pMDIs), Breath-actuated pMDIs, Dry powder inhalers (DPIs), Nebulizers, Soft Mist Inhalers.
Regularly monitoring of the Inhalation technique through mobile app
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).
Interventions
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Inhaled Corticosteroids (ICs)
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.
Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA)
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.
Other treatments
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).
Inhaler device
Pressurized metered-dose inhalers (pMDIs), Breath-actuated pMDIs, Dry powder inhalers (DPIs), Nebulizers, Soft Mist Inhalers.
Regularly monitoring of the Inhalation technique through mobile app
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of asthma.
* Undergoing treatment with inhaled corticosteroids (alone or combined with long-acting beta-agonists) for more than 6 months in the previous year.
* With access to a smart phone (their own, or their parents').
Exclusion Criteria
* Chronic obstructive pulmonary disease
* Cystic fibrosis
* Pulmonary fibrosis
* Bronchiectasis
* Active tuberculosis,
* Immunodeficiency associated with alpha 1 antitrypsin deficiency
* Ciliary diseases
6 Years
14 Years
ALL
No
Sponsors
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Parc de Salut Mar
OTHER
Responsible Party
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Principal Investigators
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Montse Ferrer Fores, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Parc de Salut Mar
Locations
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Centro de Salud de Jerez Sur
Cadiz, Andalusia, Spain
Centro de Salud La Candelaria
Seville, Andalusia, Spain
Centro de Salud Torre Ramona
Zaragoza, Aragon, Spain
Hospital Miguel Servet
Zaragoza, Aragon, Spain
Hospital Universitario Araba
Alava, Basque Country, Spain
Centro de Salud Dobra
Torrelavega, Cantabria, Spain
Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute
Barcelona, Catalonia, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Centro de Atención Primaria de la Vila Olímpica
Barcelona, Catalonia, Spain
Hospital Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Parc Taulí
Barcelona, Catalonia, Spain
Centro de Salud Segovia
Madrid, Madrid, Spain
Centro de Salud Canillejas
Madrid, Madrid, Spain
Centro de Salud Dos de Mayo Móstoles
Madrid, Madrid, Spain
Centro de Salud República de Argentina
Valencia, Valencia, Spain
Countries
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Related Links
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Recruitment platform
Other Identifiers
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PI15/00449
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ARCA2017
Identifier Type: -
Identifier Source: org_study_id
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