Data Sheet 2_Study protocol for impact of visual inhaler technique instructions on short-term outcomes in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease.docx

BackgroundAcute exacerbations (AEs) are key events in the progression of chronic obstructive pulmonary disease (COPD), accelerating the decline in lung function and increasing mortality considerably. Inhaler therapy is essential for COPD management; however, incorrect use of inhalation techniques can reduce drug efficacy and increase AE frequency. To optimize the effectiveness of inhaler use, we aim to conduct a randomized controlled trial, in which short-term visual instructions for inhalation use are provided to hospitalized patients with AE of COPD (AECOPD) to reduce AE frequency and severity within 12 weeks.
MethodsThis will be a single-center, randomized controlled trial including hospitalized patients with AECOPD who meet the inclusion criteria at the China–Japan Friendship Hospital. The patients will be randomly assigned to a visual inhaler technique instruction (VIT; experimental) or traditional inhaler technique education (TIE; control) group. During hospitalization, the TIE group will receive two standardized TIE sessions conducted by a respiratory nurse. In contrast, the VIT group will receive two VIT sessions under a physical therapist's supervision. The primary outcome will be AE frequency within 12 weeks after discharge. Secondary outcomes include all-cause mortality and each AE's severity (EXACT-Pro score) over 12 post-discharge weeks. Secondary outcomes will also include lung function, physical fitness (6-min walk test score, grip strength, and maximum voluntary contraction of knee extension), respiratory muscle strength (maximal inspiratory and expiratory pressures), dyspnea severity (modified Medical Research Council scale score), inhaler medication adherence, and quality of life (COPD Assessment Test score) at week 12 after discharge.
DiscussionWe aim to address the issues related to inhaler technique education that are often overlooked in clinical practice. Our findings may provide evidence for clinical practice and enable further optimization of inhaler technique education management strategies for patients with AECOPD.