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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.
Chronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity among older adults. Effective pMDI inhalation technique is critical for symptom control, yet improper use is common among elderly patients, especially those with cognitive decline or low health literacy. To address this, we developed an innovative training tool, "Golden Rhino" (patent number M647974, Taiwan), which utilizes a weight-calculated valve to simulate proper inhalation flow (20-60 L/min) and incorporates music cues to assist in breath timing (inhale, hold, exhale).
This randomized controlled trial investigates whether adding this tool to routine nursing education improves pMDI technique accuracy, alleviates dyspnea (via mMRC and CAT), and enhances quality of life (via EQ-5D-5L) in elderly COPD patients. Eligible participants aged 65 years and above will be enrolled from a medical center. Intervention group patients will use the device under nursing instruction for one week. The control group will receive standard verbal instructions only. Assessments occur at baseline, one week, and one month post-intervention.
The device is a non-commercial, research-use-only prototype with no financial gain or commercialization involved. This study has disclosed all relevant intellectual property in the IRB process and participant consent forms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Innovative Inhaler Training Device | Experimental | Participants receive standard pMDI inhaler education plus training using the innovative inhalation training device (e.g., 金犀利裝置) for three sessions over two weeks. |
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| Standard Nursing Education | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Innovative Inhaler Training Device (金犀利) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks |
| 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. | Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks |
| 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 | Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Hui-Tzu RN, MSN | Contact | +886 2 2875 7142 | htlin2@vghtpe.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taipei City | 11217 | Taiwan |
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This study adopts a parallel-group, two-arm randomized controlled trial design. Eligible elderly patients with COPD are randomly assigned to the control group (standard nursing guidance) or the experimental group (standard guidance plus an innovative inhaler training tool, "GoldSharp"). Outcomes are compared between groups at three time points.
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| Standard pMDI Inhaler Education | Behavioral | 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. |
|
| 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. | Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks |
| 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. | Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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