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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
Northampton General Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma Chronic

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 31, 2014
    Last Updated
    November 4, 2014
    Sponsor
    Northampton General Hospital NHS Trust
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    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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