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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02283008
Other study ID # IRAS Project ID: 153018
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 31, 2014
Last updated November 4, 2014
Start date December 2014

Study information

Verified date October 2014
Source Northampton General Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 90 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Behavioral:
Assessment of inhaler technique pre and 6 weeks post training
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Northampton General Hospital NHS Trust

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 weeks per cohort No
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