asthma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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: A potential subject who meets any of the following criteria will be excluded from participation in this study: (1) < 18 years; (2) exacerbation in the last 3 months (defined as use of antibiotics and/or prednisone short-course and/or admission to a ED or hospital).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
|---|---|
| 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) | — |
Contacts
UMCG