Long-Term Effectiveness of a Digital Inhaler on Medication Adherence and Clinical Outcomes in Adult Asthma Patients in Primary Care: The Cluster Randomized Controlled ACCEPTANCE Trial
Susanne J. van de Hei MD, PhD , Liselot N. van den Berg MSc , Charlotte C. Poot PhD , Yoran H. Gerritsma PhD , Eline Meijer PhD , Bertine M.J. Flokstra-de Blok PhD , Maarten J. Postma PhD , Job F.M. van Boven PharmD, PhD , Niels H. Chavannes MD, PhD , Janwillem W.H. Kocks MD, PhD
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引用次数: 0
Abstract
Background
Digital inhalers can support medication adherence and asthma control in the short-term. Yet, long-term benefits are unknown.
Objective
To investigate the clinical effects, usability, and cost-effectiveness of a digital inhaler.
Methods
This was an open-label cluster randomized controlled trial of 12 months in Dutch primary care. Adults with suboptimal controlled asthma and nonadherence were eligible. General practices were randomly allocated to either intervention or control, stratified by practice size. Intervention and control patients received an electronic monitoring device attached to their budesonide/formoterol SYMBICORT Turbuhaler maintenance inhaler. Intervention patients used a smartphone application for data insights and reminders. Control patients’ inhaler use was passively monitored. Primary outcome was 1-year medication adherence. Secondary outcomes included asthma control, quality of life, usability, and cost-effectiveness.
Results
Between June 27, 2019 and September 30, 2022, 136 clusters containing 164 participants were randomized (82 participants across 68 clusters in both groups). Estimated marginal means (EMM) for medication adherence were 71.4% (95% CI, 67.1-75.4) and 59.9% (95% CI, 55.0-64.7) in the intervention and control groups, respectively. Medication adherence was higher in the intervention group at week 2 (odds ratio [OR] = 2.19; 95% CI, 1.63-2.95). The difference in medication adherence between groups declined over time (P < .0001); no significant difference was found at study end (OR = 1.23; 95% CI, 0.91-1.66). Overall, Asthma Control Questionnaire-5 scores were significantly better (P = .0056) in the intervention group (EMM, 1.31; 95% CI, 1.18-1.44) compared with control (EMM, 1.56; 95% CI, 1.44-1.68). Quality of life (Mini Asthma Quality of Life Questionnaire scores) did not differ significantly between groups (P = .0530). However, the intervention group was almost three times more likely to reach the minimal clinically important difference for asthma-related quality of life (OR = 2.73; 95% CI, 1.02-7.54). Mean system usability score was 80.1 (SD, 13.8). Cost per 0.5-point Asthma Control Questionnaire-5 decrease was €278.
Conclusion
Use of this digital inhaler led to significant improvements in medication adherence in the short term and to sustained improved asthma control over 12 months.
期刊介绍：
JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases.
This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders.
The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.
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