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

NCT07305649 | Not Yet Recruiting

• 1 other identifier: 2025-06-003B
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Inhaler training; pMDI; Elderly patients; Dyspnea; Quality of life; EQ-5D; CAT; mMRC; Inhaler technique

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Change in peak expiratory flow (PEF)

  Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks

• Change in forced expiratory volume in one second (FEV₁)

  Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks

• Change in COPD Assessment Test (CAT) score

  Pre-intervention, immediately post-intervention, 4 weeks, 12 weeks

Study Arms (2)

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.

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

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.

Behavioral: Standard pMDI Inhaler Education

Interventions

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.

Innovative Inhaler Training Device; Standard Nursing Education

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.

Innovative Inhaler Training Device

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taipei City, 11217, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lin Hui-Tzu RN, MSN

CONTACT

+886 2 2875 7142; htlin2@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 26, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

TW (1)