Breathing Retraining for Asthma Trial of Home Exercises for Teenagers

NCT05006703 | Completed Results

• 2 other identifiers: CHI1071PB-PG-0817-20038
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Behavior; Asthma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Attendance at Emergency Department for an Exacerbation of Asthma

  6 months

• Hospital Admission for an Exacerbation of Asthma

  6 months

• Paediatric Quality of Life

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Access to digital intervention

Behavioral: Breathe for Teens (Breathe4T)

Control group

NO INTERVENTION

Usual care group

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Links

• Study webpage

MeSH Terms

Conditions

Adolescent Behavior; Asthma

Condition Hierarchy (Ancestors)

Behavior; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Professor Graham Roberts
• Organization: University Hospital Southampton

g.c.roberts@soton.ac.uk

02381 204335

Study Officials

• Graham Roberts

  University of Southampton

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: August 16, 2021
• Study Start: June 22, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)