Clinical trial NCT04480242: Asthma Research in Children and Adolescents
Official title: Assessment of Children and Adolescents With Asthma: An Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Persistent Asthma
Asthma in Children
Asthma Exacerbation
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 525
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spanish children and adolescents with persistent asthma seen in the outpatient pediatric pulmonology clinics and primary care pediatricians.

Brief summary: 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).

Detailed description: 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%.

Eligibility criteria: Inclusion Criteria:

* Children or adolescents aged 6-14.
* 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:

* Concomitant respiratory diseases:
* Chronic obstructive pulmonary disease
* Cystic fibrosis
* Pulmonary fibrosis
* Bronchiectasis
* Active tuberculosis,
* Immunodeficiency associated with alpha 1 antitrypsin deficiency
* Ciliary diseases

Primary outcomes:
measure: Change from baseline in symptoms control, measured with the Asthma Control Questionnaire (ACQ)
timeFrame: 2, 5, 7 and 10 years after inclusion
measure: Change from baseline in Health-Related Quality of Life, measured with the EuroQol
timeFrame: 2, 5, 7 and 10 years after downloading the ARCA app
measure: Number of severe asthmatic exacerbations
timeFrame: 5 and 10 years after inclusion
Secondary outcomes:
measure: Change from baseline in adherence to the treatment, measured with the Medication Intake Survey adherence scale-Asthma (MIS-A)
timeFrame: 2, 5, 7 and 10 years after inclusion
measure: Change from baseline in quality of the inhaler technique, measured with the Inhalation Technique Scale
timeFrame: 2, 5, 7 and 10 years after downloading the ARCA app
measure: Change from baseline in the Pediatric Asthma Impact Scale (PAIS)
timeFrame: 2, 5, 7 and 10 years after downloading the ARCA app
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Centro de Salud de Jerez Sur
state: Andalucía
city: Sevilla
country: Spain
facility: Centro de Salud La Candelaria
state: Andalucía
city: Zaragoza
country: Spain
facility: Centro de Salud Torre Ramona
state: Aragón
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
state: Aragón
city: Torrelavega
country: Spain
facility: Centro de Salud Dobra
state: Cantabria
city: Barcelona
country: Spain
facility: Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Barcelona
country: Spain
facility: Centro de Atención Primaria de la Vila Olímpica
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Parc Taulí
state: Cataluña
city: Madrid
country: Spain
facility: Centro de Salud Segovia
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Centro de Salud Canillejas
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Centro de Salud Dos de Mayo Móstoles
state: Comunidad De Madrid
city: Valencia
country: Spain
facility: Centro de Salud República de Argentina
state: Comunidad Valenciana
city: Alava
country: Spain
facility: Hospital Universitario Araba
state: País Vasco
Study officials:
affiliation: Parc de Salut Mar
name: Montse Ferrer Fores, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: