The Effectiveness of an Innovative Inhalation Training Device in Improving Medication Accuracy, Dyspnea, and Quality of Life in Elderly Patients With Chronic Obstructive Pulmonary Disease
Innovative Inhaler Training Device (金犀利)Standard pMDI Inhaler Education
Innovative Inhaler Training Device (金犀利): This 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: Participants 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
* Willing to participate and provide informed consent
Exclusion Criteria:
* 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
* Other diagnosed pulmonary diseases (e.g., lung cancer, pulmonary fibrosis) that may affect the assessment of COPD outcomes
Primary outcome measure(s)
Change in dyspnea severity — Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks 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 — Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks 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) — Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks 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
Trial sites (1)
Facility
City
Region
Status
Taipei Veterans General Hospital
Taipei
Taipei City
More Taipei Veterans General Hospital, Taiwan trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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