Breathing Retraining for Asthma Trial of Home Exercises for Teenagers

Asthma Clinical Trial

— Breathe4T  

Official title:

Breathing Retraining for Asthma Trial of Home Exercises for Teenagers (Breathe4T); Re-purposing, Refining and Feasibility - Stage 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05006703
• Other study ID #: CHI1071
• Secondary ID: PB-PG-0817-20038
• Status: Completed
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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 UK. Recruitment methods would include primary care, hospital clinics, social media and posters. Asthma UK will also provide publicity to assist recruitment.

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 information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Asthma

Intervention

Behavioral:
• Breathe4T
A digital, self-management intervention for adolescents to control their asthma using breathing retraining. The mobile-friendly website provides information about asthma and how it affects the lungs, as well as how breathing patterns can be dysfunctional. Information is presented using short (30sec-2min) video clips featuring physiotherapists, researchers and adolescent role models. Users are given tips about their practice, including choosing a suitable time and place and building up gradually. Users can plan their practice, log how their practice went and record their confidence in using the breathing techniques. There are 8 sessions including peer-led videos demonstrating breathing exercises with voiceovers and step-by-step instructions. All features and sessions can be accessed via a main dashboard where users can tailor the intervention to allow parental involvement, reminders and a preferred format for notifications (email/text). Other features include FAQs and a progress chart.

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton	Southampton	Hampshire

Sponsors (5)

Lead Sponsor	Collaborator
University of Southampton	Asthma UK, Aston University, University Hospital Southampton NHS Foundation Trust, University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma-specific quality of life	PedsQL (paediatric quality of life inventory) - asthma module - presented as a total score with a higher score indicating lower problems	6 months
Primary	Asthma Control	ACT (asthma control test) - presented as a total score with a lower score indicating poor control	6 months
Primary	Episodes of prescriptions of 3 or more days of prednisolone (or similar)	Self-reported in a healthcare utilisation questionnaire	6 months
Secondary	Attendance at emergency department for an exacerbation of asthma	Self-reported in a healthcare utilisation questionnaire	6 months
Secondary	Hospital admission for an exacerbation of asthma	Self-reported in a healthcare utilisation questionnaire	6 months
Secondary	Paediatric quality of life	PAQLQ (paediatric asthma quality life questionnaire) - presented as a total score.	6 months

External Links

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