Electronic monitoring with a digital smart spacer to support personalized inhaler use education in patients with asthma: The randomized controlled OUTERSPACE trial

Boudewijn J H Dierick; Maria Achterbosch; Amber A Eikholt; Sandra Been-Buck; Titia Klemmeier; Susanne J van de Hei; Paul Hagedoorn; Huib A M Kerstjens; Janwillem W H Kocks; Job F M van Boven

doi:10.1016/j.rmed.2023.107376

Electronic monitoring with a digital smart spacer to support personalized inhaler use education in patients with asthma: The randomized controlled OUTERSPACE trial

Respir Med. 2023 Nov:218:107376. doi: 10.1016/j.rmed.2023.107376. Epub 2023 Aug 6.

Affiliations

¹ University of Groningen, University Medical Center Groningen, Department of Clinical Pharmacy & Pharmacology, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of General Practice & Elderly Care Medicine, Groningen, the Netherlands.
² University of Groningen, University Medical Center Groningen, Department of Clinical Pharmacy & Pharmacology, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the Netherlands.
³ University of Groningen, University Medical Center Groningen, Department of Clinical Pharmacy & Pharmacology, Groningen, the Netherlands.
⁴ Department of Pulmonary Diseases, Martini Hospital, Groningen, the Netherlands.
⁵ University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Health Sciences, Groningen, the Netherlands; General Practitioners Research Institute, Groningen, the Netherlands.
⁶ University of Groningen, Groningen Research Institute of Pharmacy, Department of Pharmaceutical Technology and Biopharmacy, Groningen, the Netherlands; Medication Adherence Expertise Center of the Northern Netherlands (MAECON), Groningen, the Netherlands.
⁷ University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Pulmonology and Tuberculosis, Groningen, the Netherlands.
⁸ University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the Netherlands; Medication Adherence Expertise Center of the Northern Netherlands (MAECON), Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Pulmonology and Tuberculosis, Groningen, the Netherlands; General Practitioners Research Institute, Groningen, the Netherlands; Observational and Pragmatic Research Institute, Singapore.
⁹ University of Groningen, University Medical Center Groningen, Department of Clinical Pharmacy & Pharmacology, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, the Netherlands; Medication Adherence Expertise Center of the Northern Netherlands (MAECON), Groningen, the Netherlands. Electronic address: j.f.m.van.boven@umcg.nl.

PMID: 37549796
DOI: 10.1016/j.rmed.2023.107376

Abstract

Background: Poor adherence to inhaled medication has been associated with poor outcomes. Smart spacers can monitor inhaler use and technique, yet their feasibility in adults with asthma and their potential benefits are unknown.

Objective: Assessing the feasibility of undertaking a definitive randomized controlled trial (RCT) of smart spacer-based inhaler education and explore potential clinical benefits in adults with asthma.

Methods: Two-month randomized controlled feasibility OUtcomes following Tailored Education and Retraining: Studying Performance and AdherenCE (OUTERSPACE) trial comparing personalized smart spacer-based inhaler education versus usual care. Patients were recruited in four Dutch primary care centres. Outcomes were feasibility (inclusion speed, patient acceptance), medication adherence, inhaler technique, clinical effects (lung function, ACQ, FeNO) and usability (System Usability Scale [SUS]).

Results: 42 patients were randomized and all completed the study. The feasibility of performing a larger trial focusing on asthma patient education using a smart spacer was demonstrated with all patients included in four months and a participation rate of 86%. In the intervention group, inhalation errors per day decreased by 26.2% while in the usual care group inhalation errors increased by 14.6% (p = 0.021). Adherence decreased slightly in the intervention group as opposed to improvement in the control group (difference 12%, p = 0.028). No changes in lung function, ACQ or FeNO were observed. Usability was deemed high (SUS patients 71, nurses 89).

Conclusion: This RCT showed that smart spacer-driven education in patients with asthma is feasible and in this short-term study reduced inhaler errors. Longer-term and larger studies are required to assess clinical effects.

Keywords: Asthma; Digital health; Ehealth; Medication adherence; Persistence; Valved holding chamber.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Administration, Inhalation
Adult
Asthma* / drug therapy
Electronics
Humans
Medication Adherence
Metered Dose Inhalers
Nebulizers and Vaporizers