Performance and Adherence in Children Using Spacers (OUTER-SPACERS)

University Hospitals of North Midlands NHS Trust

Status: Enrolling

Conditions: Asthma; Asthma in Children

Treatments: Other: Tailored education; Other: Standard care education

Study type: Interventional

Funder types: Other

Identifiers

NCT05366309

3022

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard Care (Control) Group

Active Comparator group

Description:

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

Treatment:

Other: Standard care education

Tailored Education Group

Experimental group

Description:

Participants randomised to this group will receive tailored education, which is additional to standard care.

Treatment:

Other: Tailored education