Asthma in Children
Conditions
Keywords
E-health
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.
Interventions
OTHERE-Health
In the intervention phase asthma care is provided on an at-needed-basis via online communication and is always available during working hours.
Sponsors
Medisch Spectrum Twente
Philips Electronics Nederland B.V. acting through Philips CTO organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| healthcare utilization | during study period after 6 months | Difference in utilization of healthcare |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assess the effect of personalized real-time monitoring and education of inhalation | during study period (3 and 6 months) | monitoring and education of inhalation |
| To investigate the effect of supervised nebulizer therapy | during study period (3 and 6 months) | supervised nebulizer therapy |
| To correlate unobtrusive monitoring parameters and explore the feasibility and acceptance | during study period (3 and 6 months) | unobtrusive monitoring parameters |
| assesment of effect of ehealth on asthma outcomes | during study period (3 and 6 months) | asthma outcome measures |
| To analyze the preluding period before an asthma exacerbation | during study period (3 and 6 months) | preluding period |
| To identify the patient characteristics of children with successful eHealth care outcomes | during study period (3 and 6 months) | patient characteristics |
| To assess the perception of dyspnea in children | during study period (3 and 6 months) | perception of dyspnea |
Countries
Netherlands
Outcome results
None listed