Inhaler Technique Training
Primary Purpose
Asthma Chronic, Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Assessment of inhaler technique pre and 6 weeks post training
Sponsored by
About this trial
This is an interventional supportive care trial for Asthma Chronic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard care
Structured education
Arm Description
This arm will receive standard care which involves informal education on how to use metered dose inhalers
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02283008
First Posted
October 31, 2014
Last Updated
November 4, 2014
Sponsor
Northampton General Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02283008
Brief Title
Inhaler Technique Training
Official Title
Evaluating the Efficacy of 2 Different Educational Strategies for Improving and Maintaining Inhaler Technique
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northampton General Hospital NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Chronic, Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
This arm will receive standard care which involves informal education on how to use metered dose inhalers
Arm Title
Structured education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Assessment of inhaler technique pre and 6 weeks post training
Intervention Description
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
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Inhaler Technique Training
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