AmbuLatory Pediatric Asthma CAre

Study Overview
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Brief Summary
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The ALPACA study has a prospective randomized control interventional design, including a follow-up period to evaluate follow-up effects. The study is divided into two phases of 3 months using eHealth and observational monitoring.

Detailed Description
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The ALPACA study has a prospective randomized control interventional design, including a follow-up period to evaluate follow-up effects. The study is divided into two phases of 3 months; In the first phase subjects are randomized to either eHealth care (use of a communication portal including the weekly entry of SpO2, spirometry results and ACT) and explorative observational home-monitoring or only explorative observational home-monitoring during regular care. The second phase is to evaluate the effects of eHealth care compared to the control group after a follow-up period of 3 months, and the time to healthcare events during follow-up in both groups (survival analysis). The study makes use of an intention-to-treat analysis.

Official Title
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ALPACA : The Effect of Online Monitoring and Communication on the Quality and Quantity of Pediatric Asthma Care

Conditions
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Asthma in Children

Intervention / Treatment
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* Other: E-Health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with moderate-to-severe asthma. Children in the age group from 4 up to and included 11 years old. Exclusion Criteria: Children living in a house without WIFI. Prior participation in eHealth care trial. Children/Parents with an inability to understand or speak Dutch. Children with divorced parents or other reasons that causes them to be less than 80% on the same living address. Children of whom family members have already participated in this trial. Children for whom it is not possible to perform at least one of the two discontinuous dyspnea assessment (lung function/pulse oximetry). Children using an inhaler that is not compatible with the FindAir smart inhaler cap, which cannot be replaced by a compatible alternative. Children with chronic diseases other than asthma (i.e. inflammatory bowel disease, behavioral disorders, mental retardation). Currently displaying COVID-19-related symptoms, namely a fever, cough and/or difficulty breathing (during inclusion). Having been positively tested as infected with COVID-19 in the past 14 days

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In the first phase subjects are block randomized (section 7.2) to either eHealth care and explorative observational home-monitoring or only explorative observational home-monitoring during regular care. The second phase is a follow-up period of 3 months to evaluate the effects of eHealth care compared to the control group and how long these effects can last.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-Health and monitoring<br>eHealth care and explorative observational home-monitoring | Other: E-Health<br>* In the intervention phase asthma care is provided on an at-needed-basis via online communication and is always available during working hours.<br>|
| No Intervention: regular care and monitoring<br>only explorative observational home-monitoring during regular care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healthcare utilization | Difference in utilization of healthcare | during study period after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assesment of effect of ehealth on asthma outcomes | asthma outcome measures | during study period (3 and 6 months) | 
| assess the effect of personalized real-time monitoring and education of inhalation | monitoring and education of inhalation | during study period (3 and 6 months) | 
| To investigate the effect of supervised nebulizer therapy | supervised nebulizer therapy | during study period (3 and 6 months) | 
| To correlate unobtrusive monitoring parameters and explore the feasibility and acceptance | unobtrusive monitoring parameters | during study period (3 and 6 months) | 
| To assess the perception of dyspnea in children | perception of dyspnea | during study period (3 and 6 months) | 
| To analyze the preluding period before an asthma exacerbation | preluding period | during study period (3 and 6 months) | 
| To identify the patient characteristics of children with successful eHealth care outcomes | patient characteristics | during study period (3 and 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E-health