- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442617
Bridging the Gap Between Prescription and Practice: Impact of Nurse-Led Inhaler Education
Bridging the Gap Between Prescription and Practice: Impact of Nurse-Led Inhaler Education on Patient Technique, Knowledge, Adherence, and Beliefs - A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Asthma and chronic obstructive pulmonary disease (COPD) are among the most prevalent chronic respiratory conditions worldwide, affecting hundreds of millions of individuals and contributing substantially to morbidity, mortality, and healthcare burden. Inhaled therapy remains the cornerstone of management for both diseases, providing targeted delivery of bronchodilators and corticosteroids while minimizing systemic side effects.
Despite correct prescription of inhaler devices, a large proportion of patients demonstrate incorrect technique in inhaler use, leading to suboptimal drug delivery, poor symptom control, increased exacerbations, and frequent emergency department visits. Multiple factors contribute to this gap between prescription and real-world practice, including poor patient understanding of device mechanics, inappropriate inhalation patterns, and misconceptions about the nature and safety of inhaled corticosteroids.
Although clinicians routinely advise patients verbally on inhaler use, the lack of structured, hands-on education results in significant variation in technique and consistently poor retention of skills over time. Nurses, who often maintain the most direct and sustained contact with patients, represent an underutilized resource in addressing this gap. Previous studies indicate that nurse-led inhaler education can significantly enhance practical technique, reinforce adherence, and correct misconceptions about medication use. However, there is limited evidence on the long-term retention of inhaler skills and the impact of structured nurse training on both nurse competency and patient outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Al Mansurah, Egypt, 35516
- Mohamed AbdElmoniem
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged ≥18 years diagnosed with Asthma or COPD according to GINA / GOLD guidelines
- Current use of inhaler therapy (MDI, DPI, or Nebulizer) for ≥3 months.
- Able to understand instructions and perform inhaler technique assessments.
- Willing to provide informed consent and participate in all study assessments.
Exclusion Criteria:
- Acute exacerbation requiring hospitalization at the time of enrollment.
- Cognitive impairment or neurological disorders preventing understanding or proper inhaler use.
- Severe comorbidities (e.g., advanced heart failure, end-stage renal disease) that limit participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: nurse-led inhaler education
Known Patients with asthma or COPD, using inhalers and education was Conducted by trained nurses using standardized checklist (Global Initiative for Asthma "GINA"/Global Initiative for Chronic Obstructive Lung Disease "GOLD")
|
Patient Education: Conducted by trained nurses using standardized checklist (GINA/GOLD)
|
|
No Intervention: Control group on inhaler
Known Patients with asthma or COPD, using inhalers weren't trained
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
impact of nurse-led education on inhaler technique
Time Frame: 1 month
|
Participants will be evaluated to assess the impact of nurse-led education on technique Score: 152 This score evaluates the patient's ability to correctly use their inhaler.
It covers nine key 153 components: ensuring the prescribed device type is used (MDI, DPI, or nebulizer), shaking 154 the MDI before use, complete exhalation before inhalation, proper lip seal around the 155 mouthpiece or spacer, correct inhalation speed according to device type, holding breath after 156 inhalation, rinsing the mouth after corticosteroid sprays, correct use of spacer devices, and 157 overall error correction.
The maximum possible score is 9 points.
Scores are interpreted as 158 follows: ≥8 indicates excellent technique, 5-7 represents moderate performance, and ≤4 159 indicates poor technique.
The checklist was adapted from guideline-recommended inhaler 160 technique steps according to GINA and GOLD reports
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed AbdElmoniem, Lecturer of chest medicine faculty of medicine Mansoura university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.26.02.3594
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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