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NCT Number: NCT07305649

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in dyspnea severity

    Time frame: 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.

  2. Correct use of pMDI inhaler

    Time frame: 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.

  3. Health-related quality of life (HRQoL)

    Time frame: 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

Secondary outcomes

  1. Change in peak expiratory flow (PEF)

    Time frame: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks

    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).

  2. Change in forced expiratory volume in one second (FEV₁)

    Time frame: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks

    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.

  3. Change in COPD Assessment Test (CAT) score

    Time frame: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Hui-Tzu RN, MSN

CONTACT

[email protected]

+886 2 2875 7142

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Acronym: pMDII

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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