OUTER SPACE-2: a randomised study on inhaler treatment adherence using a smart spacer in adults with asthma

Completed

Conditions: asthma
10006436

Registration Number: NL-OMON49894

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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

(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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective:<br /><br>To assess the overall feasibility of undertaking a definitive randomized<br /><br>controlled trial on the effects of tailored inhaler education by the GP/nurse<br /><br>supported by a smart spacer, in primary care treated adults with asthma.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives:<br /><br>1) determine patient recruitment speed, participation rate (proportion of<br /><br>eligible patients), drop-out rate and inform sample size calculation for a<br /><br>definitive trial.<br /><br>2) assess patient and healthcare provider satisfaction with the workflow<br /><br>(System Usability Scale [SUS]).<br /><br>3) explore the distribution of medication adherence patterns (persistence and<br /><br>inhaler technique) and clinical outcomes (lung function, FeNO, Asthma Control<br /><br>Questionnaire [ACQ], Test for Adherence to Inhalers [TAI], and Work<br /><br>Productivity and Activity Impairment questionnaire [WPAI], SABA use, oral<br /><br>steroid bursts)</p><br>