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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

NCT ID: NCT07305649

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-19

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Innovative Inhaler Training Device

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.

Group Type EXPERIMENTAL

Innovative Inhaler Training Device (金犀利)

Intervention Type 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

Intervention Type 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.

Standard Nursing 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.

Group Type ACTIVE_COMPARATOR

Standard pMDI Inhaler Education

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Veterans General Hospital

Taipei, Taipei City, Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Lin Hui-Tzu RN, MSN

Role: CONTACT

Phone: +886 2 2875 7142

Email: [email protected]

Facility Contacts

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Lin Hui-Tzu RN, MSN

Role: primary

Other Identifiers

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2025-06-003B

Identifier Type: -

Identifier Source: org_study_id