Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04480242
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2020-07-13
Brief Title:
Asthma Research in Children and Adolescents
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Assessment of Children and Adolescents With Asthma An Observational Prospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCA
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 parentscaregivers 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 parentsguardians 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 patients 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 03 SD 175 patients per group would be required to have a statistical power of 80 at a significance level of 5
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 parentscaregivers 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 parentsguardians 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 patients 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 03 SD 175 patients per group would be required to have a statistical power of 80 at a significance level of 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PI1500449 | OTHER_GRANT | Instituto Salud Carlos III Fondo Europeo Desarrollo Regional | None |