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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma; Asthma in Children
• Intervention / Treatment: Other: Standard care education; Other: Tailored education

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST44JJ
      • Robert James Bowler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospitals of North Midlands NHS Trust
• Investigators: Principal Investigator: Will Carroll, PI

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): July 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 3022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No