- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07527455
Inhaler Training to Enhance Nurses' Competency in Patient Inhaler Education
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yuen Kwan Agnes Lai, PhD
- Phone Number: (852)3970-2917
- Email: ayklai@hkmu.edu.hk
Study Contact Backup
- Name: Shu Wah Ng
- Phone Number: (852)6033 9051
- Email: ngsw1@ha.org.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Registered nurses
- Holding valid practicing certificate issued by the Nursing Council of Hong Kong
Exclusion Criteria:
• Unable to speak & read Chinese
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual Training Control group
Control group receives usual training workshop
|
Control group receives usual training workshop, which is a face-to-face training for using different brands of inhalers.
|
|
Experimental: Theory-based Inhaler Training Intervention group
Intervention group receives theory-based inhaler training workshop.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and immediate after face-to-face training session.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trainees' correct steps inhaler use
Time Frame: Baseline and 4-month
|
Proportion of correct steps in inhaler use, evaluated by trained assessors with checklist.
Higher percentage of correct steps achieved means better skills.
|
Baseline and 4-month
|
|
Trainees' knowledge on inhalation maneuvers
Time Frame: Baseline, immediate after face-to-face training session and 4 months
|
Proportion of correct answer for 3-item outcome-based questionnaire.
Higher percentage of correct answer achieved means better knowledge.
|
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
|
Confidence scale on clinical nurse practice with 5 items.
Higher score means greater confidence.
|
Baseline, immediate after face-to-face training session and 4 months
|
|
Trainees' practice in patient education on inhaler use
Time Frame: 4 months
|
Three outcome-based questions (with 5-point scale) on self-reported practice in patient education.
Higher score means more practice.
|
4 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIRB-2025-116-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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