NCT02283008

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

November 5, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

October 31, 2014

Last Update Submit

November 4, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Standard care

NO INTERVENTION

This arm will receive standard care which involves informal education on how to use metered dose inhalers

Structured education

ACTIVE COMPARATOR

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.

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

Interventions

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

Structured education

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respiratory Nurse Specialist

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 5, 2014

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Last Updated

November 5, 2014

Record last verified: 2014-10