- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02283008
Inhaler Technique Training
Evaluating the Efficacy of 2 Different Educational Strategies for Improving and Maintaining Inhaler Technique
The evidence for poor inhaler technique is both well established and observed worldwide. What is unclear from the evidence is why individuals demonstrate poor technique, despite the majority admitting to having previously had instruction on inhaler technique. The primary research question is 'Will there be a difference between post education inhaler technique scores when comparing structured education against informal education?'
To try and establish why individuals use inhalers incorrectly a semi structured interview is proposed
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inclusion criteria will be anybody whose regular treatment requires inhaled medication. They will be included regardless of age, disease, inhaler device used or cognition.
Exclusion Criteria:
- The only exclusion criteria will be if a willing participant is not on an inhaler of any type.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard care
This arm will receive standard care which involves informal education on how to use metered dose inhalers
|
|
Active Comparator: Structured education
This arm will receive structured education on the use of inhalers.
At 6 weeks post education inhaler technique will be re-assessed.
Participants who fail to achieve a set level of competence may be chosen for semi structured interview.
|
Assessment of inhaler technique on day one.
Education package and training on inhaler use at week 2. Final assessment to establish maintenance of inhaler competence at week 8
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inhaler technique scores will be compared at 6 weeks post inhaler technique education. The proportion achieving proficiency will be compared between those recieving usual care and those recieving structured care.
Time Frame: 6 weeks per cohort
|
6 weeks per cohort
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS Project ID: 153018
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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