AmbuLatory Pediatric Asthma CAre

Philips

Status

Withdrawn

Conditions

Asthma in Children

Treatments

Other: E-Health

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05517096

ICBE-S-000177

Details and patient eligibility

About

Full 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.

Sex

All

Ages

4 to 11 years old

Volunteers

Accepts Healthy Volunteers

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