COPD (Chronic Obstructive Pulmonary Disease)NCT07527455
Inhaler Training to Enhance Nurses' Competency in Patient Inhaler Education
A study testing Theory-based inhaler training and Usual training in people with COPD (Chronic Obstructive Pulmonary Disease), run by Hong Kong Metropolitan University.
Trial summary
Nurses play a pivotal role in assessing, educating, and regularly reviewing patients' inhaler techniques. However, inadequate knowledge and skills among nurses can hinder their ability to accurately assess patients' inhaler technique or provide effective guidance to those receiving inhaler therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Theory-based inhaler training and Usual training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 9 Apr 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Registered nurses
- Holding valid practicing certificate issued by the Nursing Council of Hong Kong
Who cannot join
- Unable to speak \& read Chinese
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Theory-based Inhaler Training to Enhance Nurses' Competency in Patient Inhaler Education: a Randomized Controlled Trial
Nurses play a pivotal role in assessing, educating, and regularly reviewing patients' inhaler techniques. However, inadequate knowledge and skills among nurses can hinder their ability to accurately assess patients' inhaler technique or provide effective guidance to those receiving inhaler therapy. This project aims to develop an effective educational tool/program on inhaler education for healthcare workers and nurses.
This is an assessor-blinded, two-armed randomized controlled trial with a 4-month follow-up. The study will be conducted at a training institute of the Hong Kong Hospital Authority, the Institute of Advanced Nursing Studies. The intervention consists of a theory-based, face-to-face inhaler training workshop grounded in Social Learning Theory. The workshop integrates cognitive aids, hands-on demonstrations, and competency assessments using a standardized checklist. To support ongoing learning, participants will receive follow-up instructional videos and periodic reminders to reinforce and maintain their skills in patient inhaler education.
Questionnaires will be used to collect participants' demographic information and knowledge and skills regarding inhaler use at baseline, immediate post-training session and 4-month follow-up. Qualitative feedback from trainees will be collected.
Read the detailed description
COPD is the fourth leading cause of death and imposes a significant burden on healthcare systems worldwide. Inhalation therapy is the cornerstone of management for patients with COPD. However, the high rate of inhaler use errors among these patients underscores the critical need for regular monitoring and correction of inhalation techniques.
Consistent assessment and correction of inhaler use errors by nurses can significantly reduce patients' incorrect steps of inhaler use. However, inadequate knowledge and skills among nurses may hinder their ability to accurately assess patients' inhaler techniques or provide effective guidance for those undergoing inhaler therapy. By integrating cognitive aid tools with theory-based training, this study aims to develop an effective educational program on inhaler use for healthcare workers and nurses.
This study aims to examine the effectiveness of theory-based inhaler training in enhancing nurses' competency and confidence in theory-based patient inhaler education, compared with usual training. It is an assessor-blinded, two-armed randomized controlled trial with a 4-month follow-up, conducted at the Institute of Advanced Nursing Studies, Hong Kong Hospital Authority.
The intervention progresses through the four stages that begins with the attention stage, where clear demonstrations of correct inhaler techniques ensure that nurses fully understand the procedure. This is followed by the retention stage, supported by cognitive aids such as algorithms and videos to help participants remember the steps effectively. In the reproduction stage, nurses engage in return demonstrations, practicing inhaler techniques while receiving immediate feedback to reinforce their skills. Finally, the motivation stage is sustained through regular e-learning reminders and ongoing practical reinforcement, encouraging long-term mastery and consistent application of proper inhaler use.
The control group receives a face-to-face usual training. Self-administered questionnaires are used for all participants in both groups at baseline, immediately post-training, and at the 4-month follow-up. Competency in using inhalers and providing patient education will be assessed by trained assessors who are specialized respiratory nurses. Confidence in providing patient education will be assessed by questionnaire and qualitative feedback from from trainee. Statistical analyses are performed using the Statistical Package for the Social Sciences (SPSS), version 29.
- Being tested
- Theory-based inhaler training, Usual training
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Inhaler, Randomized controlled trial, Training, Nurse
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory-based inhaler trainingBehavioural
The workshop include a face-to face-training session with algorithm of device-specific inhaler maneuvers, standardized inhaler use competency assessment checklist, demonstration, and individual return. To support ongoing learning, participants receive follow-up instructional videos and reminders to strengthen and maintain their skills in patient inhaler education.
Usual trainingBehavioural
Control group receives usual training workshop, which is a face-to-face training for using different brands of inhalers.
| Study group | Role | What they receive |
|---|---|---|
| Usual Training Control group | Active comparator | Control group receives usual training workshop Receives: Behavioral: Usual training |
| Theory-based Inhaler Training Intervention group | Experimental | Intervention group receives theory-based inhaler training workshop. Receives: Behavioral: Theory-based inhaler training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trainees' correct steps inhaler use
Proportion of correct steps in inhaler use, evaluated by trained assessors with checklist. Higher percentage of correct steps achieved means better skills.
Measured: Baseline and immediate after face-to-face training session.
Secondary outcomes (4)
Trainees' correct steps inhaler use
Proportion of correct steps in inhaler use, evaluated by trained assessors with checklist. Higher percentage of correct steps achieved means better skills.
Measured: Baseline and 4-month
Trainees' knowledge on inhalation maneuvers
Proportion of correct answer for 3-item outcome-based questionnaire. Higher percentage of correct answer achieved means better knowledge.
Measured: Baseline, immediate after face-to-face training session and 4 months
Trainees' confidence in patient education on inhaler use
Confidence scale on clinical nurse practice with 5 items. Higher score means greater confidence.
Measured: Baseline, immediate after face-to-face training session and 4 months
Trainees' practice in patient education on inhaler use
Three outcome-based questions (with 5-point scale) on self-reported practice in patient education. Higher score means more practice.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start9 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- United Christian Hospital
- Responsible party
- Principal investigator, Dr Agnes LAI Yuen Kwan, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527455
- Sponsor's protocol ID
- CIRB-2025-116-3
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Did not mention during IRB application.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Theory-based Inhaler Training to Enhance Nurses' Competency in Patient Inhaler Education: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07527455
- Acronym / sponsor ID
- CIRB-2025-116-3
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Inhaler, Randomized controlled trial, Training, Nurse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Collaborators
- United Christian Hospital
- Study start
- 9 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nurses play a pivotal role in assessing, educating, and regularly reviewing patients' inhaler techniques. However, inadequate knowledge and skills among nurses can hinder their ability to accurately assess patients' inhaler technique or provide effective guidance to those receiving inhaler therapy. This project aims to develop an effective educational tool/program on inhaler education for healthcare workers and nurses.
This is an assessor-blinded, two-armed randomized controlled trial with a 4-month follow-up. The study will be conducted at a training institute of the Hong Kong Hospital Authority, the Institute of Advanced Nursing Studies. The intervention consists of a theory-based, face-to-face inhaler training workshop grounded in Social Learning Theory. The workshop integrates cognitive aids, hands-on demonstrations, and competency assessments using a standardized checklist. To support ongoing learning, participants will receive follow-up instructional videos and periodic reminders to reinforce and maintain their skills in patient inhaler education.
Questionnaires will be used to collect participants' demographic information and knowledge and skills regarding inhaler use at baseline, immediate post-training session and 4-month follow-up. Qualitative feedback from trainees will be collected.
Detailed description
COPD is the fourth leading cause of death and imposes a significant burden on healthcare systems worldwide. Inhalation therapy is the cornerstone of management for patients with COPD. However, the high rate of inhaler use errors among these patients underscores the critical need for regular monitoring and correction of inhalation techniques.
Consistent assessment and correction of inhaler use errors by nurses can significantly reduce patients' incorrect steps of inhaler use. However, inadequate knowledge and skills among nurses may hinder their ability to accurately assess patients' inhaler techniques or provide effective guidance for those undergoing inhaler therapy. By integrating cognitive aid tools with theory-based training, this study aims to develop an effective educational program on inhaler use for healthcare workers and nurses.
This study aims to examine the effectiveness of theory-based inhaler training in enhancing nurses' competency and confidence in theory-based patient inhaler education, compared with usual training. It is an assessor-blinded, two-armed randomized controlled trial with a 4-month follow-up, conducted at the Institute of Advanced Nursing Studies, Hong Kong Hospital Authority.
The intervention progresses through the four stages that begins with the attention stage, where clear demonstrations of correct inhaler techniques ensure that nurses fully understand the procedure. This is followed by the retention stage, supported by cognitive aids such as algorithms and videos to help participants remember the steps effectively. In the reproduction stage, nurses engage in return demonstrations, practicing inhaler techniques while receiving immediate feedback to reinforce their skills. Finally, the motivation stage is sustained through regular e-learning reminders and ongoing practical reinforcement, encouraging long-term mastery and consistent application of proper inhaler use.
The control group receives a face-to-face usual training. Self-administered questionnaires are used for all participants in both groups at baseline, immediately post-training, and at the 4-month follow-up. Competency in using inhalers and providing patient education will be assessed by trained assessors who are specialized respiratory nurses. Confidence in providing patient education will be assessed by questionnaire and qualitative feedback from from trainee. Statistical analyses are performed using the Statistical Package for the Social Sciences (SPSS), version 29.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Training Control group | Active comparator | Behavioral: Usual trainingControl group receives usual training workshop |
| Theory-based Inhaler Training Intervention group | Experimental | Behavioral: Theory-based inhaler trainingIntervention group receives theory-based inhaler training workshop. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Registered nurses
- Holding valid practicing certificate issued by the Nursing Council of Hong Kong
Key exclusion criteria (1 listed)
- Unable to speak \& read Chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theory-based inhaler trainingThe workshop include a face-to face-training session with algorithm of device-specific inhaler maneuvers, standardized inhaler use competency assessment checklist, demonstration, and individual return. To support ongoing learning, participants receive follow-up instructional videos and reminders to strengthen and maintain their skills in patient inhaler education. | Behavioural | Theory-based Inhaler Training Intervention group |
| Usual trainingControl group receives usual training workshop, which is a face-to-face training for using different brands of inhalers. | Behavioural | Usual Training Control group |
Primary outcome
Trainees' correct steps inhaler use
Time frame: Baseline and immediate after face-to-face training session.
Proportion of correct steps in inhaler use, evaluated by trained assessors with checklist. Higher percentage of correct steps achieved means better skills.
4 secondary outcomes
Trainees' correct steps inhaler use
Time frame: Baseline and 4-month
Trainees' knowledge on inhalation maneuvers
Time frame: Baseline, immediate after face-to-face training session and 4 months
Trainees' confidence in patient education on inhaler use
Time frame: Baseline, immediate after face-to-face training session and 4 months
Trainees' practice in patient education on inhaler use
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. Did not mention during IRB application.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Theory-based inhaler training and Usual training in people with COPD (Chronic Obstructive Pulmonary Disease), run by Hong Kong Metropolitan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuen Kwan Agnes Lai, PhD ((852)3970-2917, ayklai@hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trainees' correct steps inhaler use (time frame: Baseline and immediate after face-to-face training session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.