Asthma Asthma
Conditions
Interventions
Blended care with the addition of home spirometry. 
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
2 Years to 15 Years
Inclusion criteria
Inclusion criteria: Informed consent of parents, and of children 12 years and older; Doctor’s diagnosed asthma, preferably supported with documented significant bronchodilator response to adequate dosage of salbutamol and/or a positive bronchial provocation test;at least 6 months treated by paediatrician or paediatric pulmonologist; 6-16 yrs of age; Severe/difficult to treat asthma, defined as two or more items of: Treatment step 3 (according to the Dutch Guideline) or higher, or use of biologicals; At least 1 hospital ICU admission in the last 24 months; At least 1 hospital admission or 2 courses of prednisone in the last 12 months; At least 2 unscheduled visits to the ER and/or General Physician in the last 12 months. Chronic poor asthma control, defined as 2 or more exacerbations requiring Oral corticosteroids, 3 times an ACT< 20, or prescription of 6 or more cannisters of short acting B2- agonists per year;(willing to) Use Luchtbrug as part of routine asthma care.
Exclusion criteria
Exclusion criteria: Other chronic conditions interfering with this study/asthma:Prematurity < 36 weeks;Cardiopulmonary, neuromuscular or metabolic condition;Other pulmonary diseases.No access to internet or smartphone; Unable to understand spoken or written Dutch; Inability to conduct (home) spirometry reliably/reproducibly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study has co-primary objectives that are evaluated hierarchically. The primary clinical objective is to demonstrate non-inferiority of asthma control, measured by the Asthma Control Test (ACT) or childhood-ACT (c-ACT), in children receiving blended care with the addition of home spirometry compared with children receiving blended care alone. Conditional on demonstrating non-inferiority of asthma control, the second objective is to assess the difference in direct healthcare costs between these two care strategies. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are indirect healthcare costs, number of hospital visits and/or admissions, courses of prednisone, unscheduled medical consultations, adherence to treatment, self-management skills, quality of life and patient satisfaction. | — |
Countries
Netherlands
Contacts
Public ContactM.C.L. Kleuskens
Radboud Universitair Medisch Centrum
Outcome results
None listed