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 (pMDII)

Taipei Veterans General Hospital

Status: Not yet enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Standard pMDI Inhaler Education; Behavioral: Innovative Inhaler Training Device (金犀利)

Study type: Interventional

Funder types: Other

Identifiers

NCT07305649

2025-06-003B

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Innovative Inhaler Training Device

Experimental group

Description:

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.

Treatment:

Behavioral: Innovative Inhaler Training Device (金犀利)

Behavioral: Standard pMDI Inhaler Education

Standard Nursing Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard pMDI Inhaler Education