Breathing Retraining for Asthma Trial of Home Exercises for Teenagers

Not Applicable

Completed

Conditions: Adolescent Behavior
Asthma

Interventions: Behavioral: Breathe4T

Registration Number: NCT05006703

Lead Sponsor: University of Southampton

Brief Summary: This trial will address the impaired quality of life of young people with asthma, despite appropriate medicines. Research shows that young people report needing to calm themselves down during an asthma attack to control their breathing. Although physiotherapist- delivered breathing retraining programmes now have a clear evidence base in adults with asthma, improving quality of life, there is a lack of evidence assessing its use in younger patients. The investigators have redesigned an adult training package to make it appropriate for young people and will now assess how effective such an intervention would be in this population. This study will include young people (12-17 years) with physician diagnosed asthma. The repurposing, optimisation and acceptability of the intervention in the adolescent age group has been undertaken in Stages 1 and 2 of the Breathe 4 Teens (BREATHE4T) project. A self-guided, breathing retraining digital intervention has been developed, delivered via a mobile friendly, online platform.

The current study is a randomised, controlled feasibility trial and will provide the necessary information for a substantive cost-effectiveness trial. Participants with access to the intervention will be compared to a usual care group. Asthma and quality of life of both groups will also be assessed at baseline, 2-month and 6-month time points. At the end of the 6 months, the control group will also be given access to the website.

The online nature of this study allows recruitment from across the United Kingdom. Recruitment methods would include primary care, hospital clinics, social media and posters. AsthmaUK will also provide publicity to assist recruitment.

Detailed Description: The trial will aim to assess the acceptability, uptake and success in collecting follow up data and variance in asthma-related outcome measures. A parallel group design will be used with participants being randomised to intervention or normal management. The intervention will be a self-guided, breathing retraining digital intervention, delivered via a mobile-friendly, online platform. The intervention will continue to be used for 6 months after which both groups will be reassessed. The usual management control group will then have access to the intervention (delayed access).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 64

Inclusion Criteria

Young people aged 12-17 years
Physician diagnosed asthma
Impaired quality of life (<85)
Under the care of a general practitioner, community or hospital practitioner for their asthma

Exclusion Criteria

Co-existent respiratory conditions such as bronchiectasis
Already using breathing techniques
Already enrolled in another interventional study
Lack of informed consent
Learning difficulties
Previously involved with Stages 1 and 2 of the study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Breathe4T	Access to digital intervention

Primary Outcome Measures

Name	Time	Method
Asthma-specific Quality of Life	6 months	PedsQL (paediatric quality of life inventory) - asthma module - presented as a total score with a higher score indicating lower problems, and therefore better quality of life. Min 0 - Max 100. Scale scores are computed as the sum of the items over the number of items answered.
Asthma Control	6 months	Asthma control test (ACT) - presented as a total score with a lower score indicating poor control. Overall score above 19 would indicate well-controlled asthma. Min value 0 - Max 25.
Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar)	6 months	Self-reported in a healthcare utilisation questionnaire.

Secondary Outcome Measures

Name	Time	Method
Attendance at Emergency Department for an Exacerbation of Asthma	6 months	Self-reported in a healthcare utilisation questionnaire
Hospital Admission for an Exacerbation of Asthma	6 months	Self-reported in a healthcare utilisation questionnaire
Paediatric Quality of Life	6 months	Paediatric asthma quality life questionnaire (PAQLQ) - presented as a total score. Higher scores represent a better quality of life. Min value 1 - max 7.