ALPACA : the Effect of Online Monitoring and Communication on the Quality and Quantity of Pediatric Asthma Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- healthcare utilization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 11 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
healthcare utilization
Time Frame: during study period after 6 months
Difference in utilization of healthcare
Secondary Outcomes
- To correlate unobtrusive monitoring parameters and explore the feasibility and acceptance(during study period (3 and 6 months))
- To assess the perception of dyspnea in children(during study period (3 and 6 months))
- To analyze the preluding period before an asthma exacerbation(during study period (3 and 6 months))
- To investigate the effect of supervised nebulizer therapy(during study period (3 and 6 months))
- To identify the patient characteristics of children with successful eHealth care outcomes(during study period (3 and 6 months))
- assesment of effect of ehealth on asthma outcomes(during study period (3 and 6 months))
- assess the effect of personalized real-time monitoring and education of inhalation(during study period (3 and 6 months))