Breathing Retraining for Asthma Trial of Home Exercises for Teenagers (Breathe4T)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Adolescent Behavior
• Intervention / Treatment: Behavioral: Breathe for Teens (Breathe4T)

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).

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Access to digital intervention	Behavioral: Breathe for Teens (Breathe4T); 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.
No Intervention: Control group; Usual care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 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.	6 months
Asthma Control	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.	6 months
Episodes of Prescriptions of 3 or More Days of Prednisolone (or Similar)	Self-reported in a healthcare utilisation questionnaire.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Southampton
• Collaborators: University Hospital Southampton NHS Foundation Trust; University of Bath; Aston University; Asthma UK
• Investigators: Principal Investigator: Graham Roberts, University of Southampton

Publications and helpful links

Helpful Links

• Study webpage

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CHI1071; PB-PG-0817-20038 (Other Grant/Funding Number: NIHR RfPB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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