TY - JOUR
T1 - Long-term effectiveness of a digital inhaler on medication adherence and clinical outcomes in adult asthma patients in primary care
T2 - the cluster randomised controlled ACCEPTANCE trial
AU - van de Hei, Susanne J
AU - van den Berg, Liselot N
AU - Poot, Charlotte C
AU - Gerritsma, Yoran H
AU - Meijer, Eline
AU - Flokstra-de Blok, Bertine M J
AU - Postma, Maarten J
AU - van Boven, Job F M
AU - Chavannes, Niels H
AU - Kocks, Janwillem W H
N1 - Copyright © 2025. Published by Elsevier Inc.
PY - 2025/3/19
Y1 - 2025/3/19
N2 - 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: Open-label cluster randomised controlled trial of twelve months in Dutch primary care. Adults with suboptimal controlled asthma and non-adherence 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 usage was passively monitored. Primary outcome was 1-year medication adherence. Secondary outcomesincluded asthma control, quality of life, usability and cost-effectiveness.RESULTS: Between June 27, 2019 and September 30, 2022, 136 clusters containing 164 participants were randomised (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 group, respectively. Medication adherence was higher in the intervention group at week 2 (OR:2.19, 95%CI:1.63-2.95). The difference in medication adherence between groups declined over time (p<0.0001); no significant difference was found at study end (OR:1.23, 95%CI:0.91-1.66). Overall, ACQ-5 scores were significantly better (p=0.0056) 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-AQLQ scores) differed not significantly between groups (p=0.0530), however, the intervention group was almost three times more likely to reach the MCID 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 ACQ-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 twelve months.
AB - 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: Open-label cluster randomised controlled trial of twelve months in Dutch primary care. Adults with suboptimal controlled asthma and non-adherence 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 usage was passively monitored. Primary outcome was 1-year medication adherence. Secondary outcomesincluded asthma control, quality of life, usability and cost-effectiveness.RESULTS: Between June 27, 2019 and September 30, 2022, 136 clusters containing 164 participants were randomised (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 group, respectively. Medication adherence was higher in the intervention group at week 2 (OR:2.19, 95%CI:1.63-2.95). The difference in medication adherence between groups declined over time (p<0.0001); no significant difference was found at study end (OR:1.23, 95%CI:0.91-1.66). Overall, ACQ-5 scores were significantly better (p=0.0056) 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-AQLQ scores) differed not significantly between groups (p=0.0530), however, the intervention group was almost three times more likely to reach the MCID 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 ACQ-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 twelve months.
KW - Asthma
KW - Smart inhalers
KW - digital technologies
KW - MEDICATION ADHERENCE
KW - PRIMARY CARE
KW - TRIAL
U2 - 10.1016/j.jaip.2025.03.013
DO - 10.1016/j.jaip.2025.03.013
M3 - Article
C2 - 40118212
SN - 2213-2198
JO - The journal of allergy and clinical immunology. In practice
JF - The journal of allergy and clinical immunology. In practice
ER -