Robert James Bowler
Stoke-on-Trent, Staffordshire, ST44JJ, United Kingdom
NCT Number: NCT05366309
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.
This study is active but is not currently recruiting participants.
6 year–18 year
All sexes
Interventional
Not applicable
Stoke-on-Trent, Staffordshire, ST44JJ, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants randomised to this group will receive usual care in terms of their education.
Time frame: From recruitment up until 12-16 weeks follow-up time point
Overall adherence
Time frame: From recruitment up until 12-16 weeks follow-up time point
Proportion eligible
Time frame: From recruitment up until 12-16 weeks follow-up time point
Recruitment and attrition
Time frame: From recruitment up until 12-16 weeks follow-up time point
Success rate
Time frame: At 12-16 weeks follow-up time point
SUS
Time frame: At 12-16 weeks follow-up time point
NPS
Time frame: From recruitment to 12-16 weeks follow-up time point
Device failure
Time frame: From recruitment to 12-16 weeks follow-up time point
ACT
Time frame: From recruitment to 12-16 weeks follow-up time point
ACQ
Time frame: From recruitment to 12-16 weeks follow-up time point
GINA
Time frame: From recruitment to 12-16 weeks follow-up time point
Salbutamol use
Time frame: From recruitment to 12-16 weeks follow-up time point
Oral steroid burst use
Time frame: From recruitment to 12-16 weeks follow-up time point
m-PAQLQ
Time frame: From recruitment to 12-16 weeks follow-up time point
FEV1 z
Time frame: From recruitment to 12-16 weeks follow-up time point
FeNO (ppb)
Time frame: From recruitment to 12-16 weeks follow-up time point
UKIG
University Hospitals of North Midlands NHS Trust
Other
OUtcome Following Tailored Education and Retraining: Studying Performance and Adherence in ChildrEn and Young People With Asthma: a Randomised Feasibility Study
Acronym: OUTER-SPACERS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06321471
Asthma, Asthma in Children
Los Angeles, California, United States
View Trial DetailsNCT06201494
Asthma, Asthma in Children
Prague, Czechia
View Trial DetailsNCT06159127
Asthma, Asthma in Children
Cincinnati, Ohio, United States
View Trial DetailsNCT07011394
Asthma, Asthma in Children
Montreal, Quebec, Canada
View Trial Details