125 ACCEPTANCE protocol 5 Run-in Intervention 1 2 3 4 5 6 T-1 T0 T3 T6 T9 T12 Non-patient assessments Log data X Inhaler actuations (EMD) Data collected over time interval T-1–T12 Reliever inhalation actuations (EMD)‡ Data collected over time interval T0–T12 Medication use§ X Healthcare professional assessments TAQ†¶ X X SUS†¶ X X *At T0, T6, T12 structured interview, at T3 and T9 paper questionnaires (same questions). Healthcare use data covering the study period will be retrieved from the patient’s general practice electronic health record system at study end. †Questionnaires only administered to the intervention group. ‡Only patients that use an EMD compatible reliever inhaler. §Medication use data during the study and the year prior to the study will be retrieved from the patient’s main pharmacist dispense system. ¶Only for HCPs that participate in the study (option A, option B1 and B2). ACQ, Asthma Control Questionnaire; BMQ-Specific, Beliefs about Medicine Questionnaire–Specific; eHLQ, eHealth Literacy Questionnaire; EMD, electronic monitoring device; IPQ, Illness Perception Questionnaire; KASE-AQ, Knowledge Attitude Self Efficacy-Asthma Questionnaire; Mini- AQLQ, Mini Asthma-Related Quality of Life Questionnaire; SUS, System Usability Scale; TAQ, Technology Acceptance Questionnaire; WPAI, Work Productivity and Activity Impairment. Study outcomes Primary outcome The primary outcome of this study is medication adherence over 12 months, as measured objectively by electronic monitoring of inhaler actuations. The treatment effect will be expressed as the mean absolute difference in medication adherence between the smart inhaler programme group and the control group. Medication adherence is defined as the percentage of daily inhalations taken as prescribed (number of recorded inhalations per day/number of maintenance inhalations prescribed per dayx100), corrected for dose dumping. Dose dumping is defined as ≥6 actuations within a 5 minute period. Daily adherence will be capped at 100% (i.e., to avoid falsely increased values).
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