A Study to Identify Errors in Inhaler Technique in Adults

  • STATUS
    Recruiting
  • participants needed
    650
  • sponsor
    Portsmouth Hospitals NHS Trust
Updated on 19 February 2024

Summary

This study will observe the inhaler technique of people using 13 different inhaler types; record any technique errors being made against checklists developed for each inhaler device based on their manufacturer's guidelines, and reeducate any observed inhaler technique errors as required.

Description

Anyone aged 16 or over who has a lung condition for which they use an inhaler will be invited to join the study. We will recruit a minimum of 650 study participants, with at least 50 participants using each of the 13 inhaler device types selected. These inhaler device types include: Accuhaler, Autohaler, Breezhaler, Easi-breathe, Easyhaler, Ellipta, Genuair, Handihaler, Nexthaler, pMDI, pMDI plus spacer, Respimat and Turbohaler. Participants will be recruited from respiratory outpatient clinics, hospital wards and from staff at Queen Alexandra Hospital (QAH); from integrated outreach lung clinics, GP database searches, clinics run in primary care settings, respiratory support groups in the Hampshire region, and from students at the University of Portsmouth (UoP).

Participants in this study will have their inhaler technique observed and corrected by a specialist clinician, such as a nurse, pharmacist, physiotherapist or doctor using a single-use placebo device. A placebo device is exactly the same as the inhaler that the participant uses, but there is no active medication in the device. If any errors are made using the placebo inhaler, these will be recorded using device-specific checklists based on manufacturers' guidelines.

Correcting inhaler technique is vitally important in the management of respiratory conditions . Observing patients using their inhaler, identifying any errors in their technique, teaching the correct inhaler technique and then observing the patient repeating the procedure correctly should occur at the time of device prescription; however this often does not happen and patients are left unsure how to use their inhaler and errors are commonplace. After inhaler technique has been corrected in this study, a written information sheet with guidance on how to use the inhaler will be provided to each participant to help reinforce the correct technique.

Alongside recording any errors that participants using the inhalers have made, we will also record additional information such as the type of inhaler they are observed using and how long they have been using that inhaler; their age, gender and how many other inhalers they are using in total; which lung condition they have and how badly it affects them and if they have any other medical conditions. We will also record information using a questionnaire called the SPURTM profiling tool, which assesses patients' beliefs and understanding around their medication; this will be done using an iPad/tablet and all data that is inputted will be anonymous and kept securely, as with all other information.

The information collected on this study will help HCP better understand which inhaler technique errors are made most frequently associated with each different inhaler device. We will also use the information gathered in this study, along with additional information gathered from inhaler experts, to develop a method of scoring inhaler technique errors, which will be tested in a future study. Such a scoring system does not currently exist in the UK and will be a valuable tool in clinical practice to accurately measure how good people are at using their inhalers.

Details
Condition Respiratory Tract Diseases, Respiratory disorder
Age 16-100 years
Clinical Study IdentifierNCT04262271
SponsorPortsmouth Hospitals NHS Trust
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 16 years
Have been prescribed (by a doctor or healthcare professional) 1 of 13 inhaler device types for an airways condition
Accuhaler, Autohaler, Breezhaler, Easi-breathe, Easyhaler, Ellipta, Genuair, Handihaler, Nexthaler, pMDI, pMDI plus spacer (e.g. Aerochamber or Volumatic), Respimat and Turbohaler
Able to provide written informed consent

Exclusion Criteria

Currently on treatment with systemic steroids and/or antibiotics for an exacerbation of the participants' airways condition
In the opinion of the investigator that the participant will be unable to perform the study procedures
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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