Performance and Adherence in Children Using Spacers

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma, Asthma in Children

Intervention / Treatment
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* Other: Tailored education
* Other: Standard care education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care (Control) Group<br>Participants randomised to this group will receive usual care in terms of their education. | Other: Standard care education<br>* Participants randomised to this group will receive usual care in terms of their education.<br>|
| Experimental: Tailored Education Group<br>Participants randomised to this group will receive tailored education, which is additional to standard care. | Other: Tailored education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall adherence to inhaled treatment (the product of persistence (number of doses taken as prescribed) and technique) | Overall adherence | From recruitment up until 12-16 weeks follow-up time point | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of children and young people with asthma who are eligible for participation within the study from secondary care via screening logs | Proportion eligible | From recruitment up until 12-16 weeks follow-up time point | 
| Recruitment and attrition rates over the study via screening and enrolment logs | Recruitment and attrition | From recruitment up until 12-16 weeks follow-up time point | 
| The success rate of obtaining data from the Smart spacer device | Success rate | From recruitment up until 12-16 weeks follow-up time point | 
| Feedback from System Usability Score (SUS) | SUS | At 12-16 weeks follow-up time point | 
| Feedback from Net Promoter Score (NPS) | NPS | At 12-16 weeks follow-up time point | 
| Rate of device failure from any cause (including loss of device, inability to retrieve data from SD card) | Device failure | From recruitment to 12-16 weeks follow-up time point | 
| Asthma control test (ACT) or Childhood Asthma Control Test (c-ACT) | ACT | From recruitment to 12-16 weeks follow-up time point | 
| Asthma Control Questionnaire | ACQ | From recruitment to 12-16 weeks follow-up time point | 
| GINA control score | GINA | From recruitment to 12-16 weeks follow-up time point | 
| Salbutamol (rescue) use | Salbutamol use | From recruitment to 12-16 weeks follow-up time point | 
| Need for oral steroid burst | Oral steroid burst use | From recruitment to 12-16 weeks follow-up time point | 
| m-PAQLQ score | m-PAQLQ | From recruitment to 12-16 weeks follow-up time point | 
| FEV1 z score | FEV1 z | From recruitment to 12-16 weeks follow-up time point | 
| FeNO (ppb) | FeNO (ppb) | From recruitment to 12-16 weeks follow-up time point | 
| UKIG score | UKIG | From recruitment to 12-16 weeks follow-up time point |