Overview
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.
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
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