Clinical trial NCT05517096: AmbuLatory Pediatric Asthma CAre
Official title: ALPACA : the Effect of Online Monitoring and Communication on the Quality and Quantity of Pediatric Asthma Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Asthma in Children
Keywords: E-health
Lead sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
Sponsor class: INDUSTRY
Collaborators: name: Medisch Spectrum Twente
First posted: 2022-08-26
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: healthcare utilization
timeFrame: during study period after 6 months
Secondary outcomes:
measure: assesment of effect of ehealth on asthma outcomes
timeFrame: during study period (3 and 6 months)
measure: assess the effect of personalized real-time monitoring and education of inhalation
timeFrame: during study period (3 and 6 months)
measure: To investigate the effect of supervised nebulizer therapy
timeFrame: during study period (3 and 6 months)
measure: To correlate unobtrusive monitoring parameters and explore the feasibility and acceptance
timeFrame: during study period (3 and 6 months)
measure: To assess the perception of dyspnea in children
timeFrame: during study period (3 and 6 months)
measure: To analyze the preluding period before an asthma exacerbation
timeFrame: during study period (3 and 6 months)
measure: To identify the patient characteristics of children with successful eHealth care outcomes
timeFrame: during study period (3 and 6 months)
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: MST
Study officials:
affiliation: Medisch Spectrum Twente
name: B.J. Thio, Pediatrician
role: PRINCIPAL_INVESTIGATOR
References: