RecruitingNot ApplicableNCT05366309

Performance and Adherence in Children Using Spacers

OUtcome Following Tailored Education and Retraining: Studying Performance and Adherence in ChildrEn and Young People With Asthma: a Randomised Feasibility Study


Sponsor

University Hospitals of North Midlands NHS Trust

Enrollment

100 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Asthma is a common disease which causes swelling in the airways, making it difficult to breathe. Asthma is common in children, affecting 1 in 11 children in the UK. Asthma is treated with inhalers which reduce the swelling. If inhalers are taken correctly they can help keep symptoms under control, allowing asthma sufferers to go about their day with less chance of having an asthma attack. Many patients have been found to not take their inhalers correctly and either under use (which leads to poor control of symptoms) or over use (which leads to potential side effects). Although asthma in most patients can be controlled with inhalers, not using inhalers correctly is one of the most common causes of poor control. This is common in children and young people (CYP) with all severities of asthma, resulting in high burden on the families and healthcare systems. The biggest challenge facing doctors and nurses helping CYP with asthma is finding a way to ensure that they take the medication. Whilst there are many studies looking into inhaler use, there are no large studies about how inhalers are used between clinic visits in CYP with asthma. The Smart Spacer is monitoring device which allows doctors to monitor when and how effectively inhalers are being used. This study wants to find out how well this device works, how well and how often CYP are using their inhalers, and if tailored education improves asthma control. To do this, participants in the study will be randomly selected to have "tailored education" or "standard care education". The investigators are inviting 100 children and young people (CYP) aged 6-18 years who have asthma to join this study.


Eligibility

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how children with asthma use their inhaler spacers (the tube-like devices that help deliver asthma medication) and whether they use them correctly and regularly. Researchers want to measure lung function and how well children follow their treatment plans. **You may be eligible if...** - You are between 6 and 18 years old - You have been diagnosed with asthma and are seen at a specialist clinic - You take twice-daily preventer inhaler medication through a spacer device - You are able to do breathing tests (lung function and exhaled nitric oxide tests) **You may NOT be eligible if...** - You have another significant lung disease such as cystic fibrosis - You are currently enrolled in another clinical trial - You are not an English speaker and no translation support is available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTailored education

Tailored Education: A delegated investigator will review the SD memory card data and share the results with the participant and/or parent/guardian. The investigator will explain whether there are partial or critical errors to inhalation technique that have been recorded. The participant will be informed about their overall adherence; including how and when they used their asthma medications. If errors in medication use are identified, specific coaching will be provided to help eliminate errors.

OTHERStandard care education

Participants randomised to this group will receive usual care in terms of their education.


Locations(1)

Robert James Bowler

Stoke-on-Trent, Staffordshire, United Kingdom

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NCT05366309


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