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Completed

NCT Number: NCT05006703

Breathing Retraining for Asthma Trial of Home Exercises for Teenagers

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathe for Teens (Breathe4T)

Behavioral

A digital, self-management intervention for adolescents to control their asthma using breathing retraining. The mobile-friendly website provides information about asthma, how it affects the lungs, and 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 and log their practice 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 frequently asked questions (FAQs) and a progress chart.

Primary outcomes

  1. Asthma-specific Quality of Life

    Time frame: 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.

  2. Asthma Control

    Time frame: 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.

  3. Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar)

    Time frame: 6 months

    Self-reported in a healthcare utilisation questionnaire.

Secondary outcomes

  1. Attendance at Emergency Department for an Exacerbation of Asthma

    Time frame: 6 months

    Self-reported in a healthcare utilisation questionnaire

  2. Hospital Admission for an Exacerbation of Asthma

    Time frame: 6 months

    Self-reported in a healthcare utilisation questionnaire

  3. Paediatric Quality of Life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Collaborators

  • Asthma UK
  • Aston University
  • University Hospital Southampton NHS Foundation Trust
  • University of Bath

Registry information

Official study title

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

Acronym: Breathe4T

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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