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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24135
Enrollment
40
Registered
2021-06-30
Start date
2021-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma

Interventions

the intervention group will receive personalized, tailored education by a GP/nurse supported by data of a smart spacer.

Sponsors

UMCG
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactBoudewijn Dierick

UMCG

b.j.h.dierick@umcg.nl0515231770

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)