Clinical trial NCT05366309: Performance and Adherence in Children Using Spacers
Official title: OUtcome Following Tailored Education and Retraining: Studying Performance and Adherence in ChildrEn and Young People With Asthma: a Randomised Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Asthma in Children
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 criteria: Inclusion Criteria:

* Aged 6-18 years;
* Attending secondary care with a diagnosis of asthma;
* Willing and able to give fully informed consent, or, participants having an acceptable individual capable of giving consent on the participant's behalf (e.g. parent or guardian of a child under 16 years of age);
* Able to perform lung function and exhaled nitric oxide measurements;
* Take twice-daily preventer medication using a valved holding chamber (spacer device) i.e. inhaled corticosteroid with or without long-acting beta antagonist;
* Willing and able to comply with the study procedures.

Exclusion Criteria:

* Significant co-existing respiratory disease (e.g. cystic fibrosis);
* Currently participating in another clinical trial of an investigational medicinal product or medical device;
* Non-English speaker where translation facilities are insufficient to guarantee informed consent.

Primary outcomes:
measure: Overall adherence to inhaled treatment (the product of persistence (number of doses taken as prescribed) and technique)
timeFrame: From recruitment up until 12-16 weeks follow-up time point
Secondary outcomes:
measure: The proportion of children and young people with asthma who are eligible for participation within the study from secondary care via screening logs
timeFrame: From recruitment up until 12-16 weeks follow-up time point
measure: Recruitment and attrition rates over the study via screening and enrolment logs
timeFrame: From recruitment up until 12-16 weeks follow-up time point
measure: The success rate of obtaining data from the Smart spacer device
timeFrame: From recruitment up until 12-16 weeks follow-up time point
measure: Feedback from System Usability Score (SUS)
timeFrame: At 12-16 weeks follow-up time point
measure: Feedback from Net Promoter Score (NPS)
timeFrame: At 12-16 weeks follow-up time point
measure: Rate of device failure from any cause (including loss of device, inability to retrieve data from SD card)
timeFrame: From recruitment to 12-16 weeks follow-up time point
measure: Asthma control test (ACT) or Childhood Asthma Control Test (c-ACT)
timeFrame: From recruitment to 12-16 weeks follow-up time point
measure: Asthma Control Questionnaire
timeFrame: From recruitment to 12-16 weeks follow-up time point
measure: GINA control score
timeFrame: From recruitment to 12-16 weeks follow-up time point
measure: Salbutamol (rescue) use
timeFrame: From recruitment to 12-16 weeks follow-up time point
measure: Need for oral steroid burst
timeFrame: From recruitment to 12-16 weeks follow-up time point
measure: m-PAQLQ score
timeFrame: From recruitment to 12-16 weeks follow-up time point
measure: FEV1 z score
timeFrame: From recruitment to 12-16 weeks follow-up time point
measure: FeNO (ppb)
timeFrame: From recruitment to 12-16 weeks follow-up time point
measure: UKIG score
timeFrame: From recruitment to 12-16 weeks follow-up time point
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: Robert James Bowler
state: Staffordshire
Study officials:
affiliation: PI
name: Will Carroll
role: PRINCIPAL_INVESTIGATOR
References: