Clinical trial NCT05006703: Breathing Retraining for Asthma Trial of Home Exercises for Teenagers
Official title: Breathing Retraining for Asthma Trial of Home Exercises for Teenagers (Breathe4T); Re-purposing, Refining and Feasibility - Stage 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Asthma
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: University of Bath
name: Aston University
name: University Hospital Southampton NHS Foundation Trust
name: Asthma UK
First posted: 2021-08-16
Enrollment: 64
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Asthma-specific Quality of Life
timeFrame: 6 months
measure: Asthma Control
timeFrame: 6 months
measure: Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar)
timeFrame: 6 months
Secondary outcomes:
measure: Attendance at Emergency Department for an Exacerbation of Asthma
timeFrame: 6 months
measure: Hospital Admission for an Exacerbation of Asthma
timeFrame: 6 months
measure: Paediatric Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hampshire
Study officials:
affiliation: University of Southampton
name: Graham Roberts
role: PRINCIPAL_INVESTIGATOR
References: