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

U

University of Southampton

Status

Completed

Conditions

Asthma
Adolescent Behavior

Treatments

Behavioral: Breathe for Teens (Breathe4T)

Study type

Interventional

Funder types

Other

Identifiers

NCT05006703
CHI1071
PB-PG-0817-20038 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment

64 patients

Sex

All

Ages

12 to 17 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Intervention group
Experimental group
Description:
Access to digital intervention
Treatment:
Behavioral: Breathe for Teens (Breathe4T)
Control group
No Intervention group
Description:
Usual care group

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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