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.
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
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.
- Conditions
- Respiratory Disease
- Medical subject headings
- Respiration Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted10 Feb 2020
- Study start7 Aug 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Identify the Prevalence of Device Specific Errors in Inhaler Technique in Adults With Airways Disease
- ClinicalTrials.gov ID
- NCT04262271
- Acronym / sponsor ID
- SCORES / PHT/2019/13
- Conditions
- Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 734 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Any person over the age of 16 who uses and inhaler device for an airways condition.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Device Specific inhaler technique errors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Derived from this study: PubMed 34448728De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.