asthma
Conditions
Interventions
The investigational treatment is tailored inhaler use education, supported by
data generated by a smart spacer. In addition to usual care, patients in the
intervention group receive detailed informa
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) adults >= 18 years; (2) physician diagnosed asthma treated in primary care; (3) using any inhaled corticosteroid (ICS) (+/-long-acting beta agonist [LABA] +/- short-acting beta agonist [SABA]) administered by a pressurized Metered Dose Inhaler (pMDI) and a spacer; (4) willing to sign informed consent.
Exclusion criteria
Exclusion criteria: (1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: To assess the overall feasibility of undertaking a definitive randomized controlled trial on the effects of tailored inhaler education by the GP/nurse supported by a smart spacer, in primary care treated adults with asthma. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: 1) determine patient recruitment speed, participation rate (proportion of eligible patients), drop-out rate and inform sample size calculation for a definitive trial. 2) assess patient and healthcare provider satisfaction with the workflow (System Usability Scale [SUS]). 3) explore the distribution of medication adherence patterns (persistence and inhaler technique) and clinical outcomes (lung function, FeNO, Asthma Control Questionnaire [ACQ], Test for Adherence to Inhalers [TAI], and Work Productivity and Activity Impairment questionnaire [WPAI], SABA use, oral steroid bursts) | — |
Countries
Netherlands
Outcome results
None listed