AzTrials
AzTrials

Respiratory DiseaseSCORESNCT04262271

A Study to Identify Errors in Inhaler Technique in Adults

An observational study of Respiratory Disease, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Respiratory Disease
How many people
734 participants
Where
1 siteUnited Kingdom
Study dates
7 Aug 2019to 30 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Child, Adult, Older adult

Study population: Any person over the age of 16 who uses and inhaler device for an airways condition.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Portsmouth Hospitals NHS Trust

    Portsmouth, PO6 3LY

Other trials in United Kingdom

About this study

Official title: A Study to Identify the Prevalence of Device Specific Errors in Inhaler Technique in Adults With Airways Disease

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.

Read the detailed description

Anyone aged 16 or over who has a lung condition for which they use an inhaler will be invited to join the study. The investigators 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, the investigators 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. The investigators 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. The investigators 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.

Medical subject headings
Respiration Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the prevalence of device-specific inhaler technique errors (ITE), in 13 different devices using manufacturers' guidelines.

    Device Specific inhaler technique errors

    Measured: one study visit- day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start7 Aug 2019
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
734 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04262271
Sponsor's protocol ID
PHT/2019/13
Acronym
SCORES
Status last verified
Apr 2023
First submitted
7 Feb 2020
Last updated
10 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • De Vos R, Brown T, Longstaff J, Lomax M, Mackenzie H, Hicks A, Rupani H, Gates J, Fox L, Wiffen L, Chauhan AJ. A Study to Investigate the Prevalence of Device-Specific Errors in Inhaler Technique in Adults With Airway Disease (The SCORES Study): Protocol for a Single Visit Prevalence Study. JMIR Res Protoc. 2021 Aug 27;10(8):e26350. doi: 10.2196/26350.

    PubMed 34448728

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Disease, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the prevalence of device-specific inhaler technique errors (ITE), in 13 different devices using manufacturers' guidelines. (time frame: one study visit- day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04262271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.

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