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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in dyspnea severity [Срок оценки: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks]
• Correct use of pMDI inhaler [Срок оценки: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks]
• Health-related quality of life (HRQoL) [Срок оценки: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks]

Вторичные конечные точки (3)

• Change in peak expiratory flow (PEF) [Срок оценки: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks]
• Change in forced expiratory volume in one second (FEV₁) [Срок оценки: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks]
• Change in COPD Assessment Test (CAT) score [Срок оценки: Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Тайвань · 1 центр

• Taipei Veterans General Hospital — Taipei

Идентификаторы

NCT: NCT07305649 · 2025-06-003B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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