This study aims to evaluate the effectiveness of an innovative inhaler training device, "Golden Rhino" (pMDI Practice Tool), in improving inhalation technique accuracy, dyspnea severity, and quality of life among elderly patients with chronic obstructive pulmonary disease (COPD). The device integrates a weighted valve and musical cues to guide patients in synchronizing their breath with proper pMDI inhalation technique. Participants will be randomly assigned to either standard nursing guidance or nursing guidance plus device-based training. Outcome measures include pMDI usage accuracy, dyspnea severity, and EQ-5D quality of life scores at baseline and follow-up.
Age ≥ 65 years old
Clinically diagnosed with Chronic Obstructive Pulmonary Disease (COPD) according to GOLD criteria
Currently using pressurized Metered Dose Inhaler (pMDI) medications
Ability to communicate and understand instructions in Mandarin or Taiwanese
Diagnosis of severe cognitive impairment (e.g., dementia) that may interfere with participation
Acute COPD exacerbation requiring hospitalization within the past 30 days
Concurrent enrollment in another interventional clinical trial
Severe visual or hearing impairment that may limit the ability to follow inhaler training instructions
Parallel
Innovative Inhaler Training Device (金犀利)
BehavioralThis intervention involves the use of an innovative inhaler training device designed to assist elderly COPD patients in mastering the correct pMDI inhalation technique. The device provides visual and auditory feedback during training and is used in conjunction with individualized nursing instruction. The goal is to improve medication administration accuracy, reduce dyspnea, and enhance quality of life.
Standard pMDI Inhaler Education
BehavioralParticipants receive standard pMDI inhaler education only, based on established clinical nursing guidelines. No additional device or interactive training is provided. The education includes written and verbal instructions on proper pMDI use.
Change in dyspnea severity
Dyspnea severity will be measured using the modified Medical Research Council (mMRC) dyspnea scale. The mMRC is a 5-point scale ranging from 0 (no dyspnea) to 4 (dyspnea on minimal exertion). Participants will self-report their score at baseline, post-intervention, and 4-week follow-up. Reduction of at least 1 point is considered clinically significant.
Correct use of pMDI inhaler
Correct inhaler technique will be assessed using a 10-item standardized checklist. Each item is scored as correct (1) or incorrect (0). Total scores range from 0 to 10. Participants will be observed by trained nursing staff during inhaler use at three time points: baseline, post-intervention (2 weeks), and follow-up (4 weeks). A score ≥9 is considered correct use.
Health-related quality of life (HRQoL)
Health-related quality of life will be assessed using the EQ-5D-5L instrument, including both the index score (calculated using the China value set from Luo et al., 2017, DOI: 10.1007/s10198-017-0870-1 ) and the EQ-VAS score. The EQ-5D index score ranges from \<0 (worse than death) to 1 (perfect health). The EQ-VAS is a visual analog scale from 0 to 100 representing self-rated health
Change in peak expiratory flow (PEF)
Peak expiratory flow will be measured using the MIR Smart One digital spirometer. Participants will perform three trials, and the highest value will be recorded in liters per minute (L/min). PEF reflects airway obstruction and inhalation-exhalation efficacy. Measurements will be taken at baseline, post-intervention (2 weeks), and follow-up (4 weeks).
Change in forced expiratory volume in one second (FEV₁)
FEV₁ will also be assessed using the MIR Smart One device. Three measurements will be taken, and the highest value recorded in liters (L). FEV₁ is a standard measure of lung function in COPD and will be compared across time points to assess improvement.
Change in COPD Assessment Test (CAT) score
The CAT is an 8-item self-administered questionnaire assessing the impact of COPD on health status. Each item is scored from 0 to 5, with a total score range of 0-40. Higher scores indicate worse health status. A reduction of 2 or more points is considered clinically meaningful.
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