asthma
Conditions
Interventions
Participants in the smart inhaler based self-management programme group will
use an electronic monitoring device attached to their regular maintenance
inhaler, which will be connected to an applicat
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >= 18 years; Doctor-diagnosed asthma (according to Dutch national primary care asthma guidelines (NHG)) - route A and B; Self-reported asthma diagnosis (confirmed at study end (T12) by GP) - route C; Partially controlled or uncontrolled asthma (ACQ >= 0.75); Use of Symbicort Turbuhaler maintenance therapy; Being 'non-adherent' defined as an adherence rate (number of fully adherent days / total number of days) of below 80% over the 3rd and 4th week of the run-in period.
Exclusion criteria
Exclusion criteria: Use of SMART regimen (Symbicort Maintenance And Reliever Therapy) by taking Symbicort as reliever in response to symptoms; Change in inhaled corticosteroids dose in the 4 weeks prior to run-in period; Use of systemic corticosteroids in the 4 weeks prior to run-in period; Current use of biologics, (anti-IL-5 en anti-IgE); Diagnosis of COPD or other significant respiratory diseases; Malignancy with life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcome is the difference in medication adherence between the smart inhaler based self-management programme group and the control group over twelve months as measured by electronic monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include asthma control (ACQ-5), asthma-related quality of life (mini-AQLQ), exacerbations, reliever use, usability and acceptability (patients and health care professionals), patient characteristics (self-efficacy, attitude, medication beliefs, illness perception, eHealth literacy), work productivity (WPAI) and health utilization. | — |
Countries
Netherlands
Outcome results
None listed