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

Primary Purpose

Adolescent Behavior, Asthma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Breathe4T
Sponsored by
University of Southampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adolescent Behavior

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts 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

Sites / Locations

  • University Hospital Southampton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Access to digital intervention

Usual care group

Outcomes

Primary Outcome Measures

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
Asthma Control
ACT (asthma control test) - presented as a total score with a lower score indicating poor control
Episodes of prescriptions of 3 or more days of prednisolone (or similar)
Self-reported in a healthcare utilisation questionnaire

Secondary Outcome Measures

Attendance at emergency department for an exacerbation of asthma
Self-reported in a healthcare utilisation questionnaire
Hospital admission for an exacerbation of asthma
Self-reported in a healthcare utilisation questionnaire
Paediatric quality of life
PAQLQ (paediatric asthma quality life questionnaire) - presented as a total score.

Full Information

First Posted
June 23, 2021
Last Updated
November 1, 2022
Sponsor
University of Southampton
Collaborators
University of Bath, Aston University, University Hospital Southampton NHS Foundation Trust, Asthma UK
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1. Study Identification

Unique Protocol Identification Number
NCT05006703
Brief Title
Breathing Retraining for Asthma Trial of Home Exercises for Teenagers
Acronym
Breathe4T
Official Title
Breathing Retraining for Asthma Trial of Home Exercises for Teenagers (Breathe4T); Re-purposing, Refining and Feasibility - Stage 3
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton
Collaborators
University of Bath, Aston University, University Hospital Southampton NHS Foundation Trust, Asthma UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Behavior, Asthma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Access to digital intervention
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care group
Intervention Type
Behavioral
Intervention Name(s)
Breathe4T
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma-specific quality of life
Description
PedsQL (paediatric quality of life inventory) - asthma module - presented as a total score with a higher score indicating lower problems
Time Frame
6 months
Title
Asthma Control
Description
ACT (asthma control test) - presented as a total score with a lower score indicating poor control
Time Frame
6 months
Title
Episodes of prescriptions of 3 or more days of prednisolone (or similar)
Description
Self-reported in a healthcare utilisation questionnaire
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Attendance at emergency department for an exacerbation of asthma
Description
Self-reported in a healthcare utilisation questionnaire
Time Frame
6 months
Title
Hospital admission for an exacerbation of asthma
Description
Self-reported in a healthcare utilisation questionnaire
Time Frame
6 months
Title
Paediatric quality of life
Description
PAQLQ (paediatric asthma quality life questionnaire) - presented as a total score.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham Roberts
Organizational Affiliation
University of Southampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Southampton
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.southampton.ac.uk/breathe4t
Description
Related Info
URL
https://www.ed.ac.uk/usher/aukcar/knowledge-hub/projects/breathe4t
Description
Related Info

Learn more about this trial

Breathing Retraining for Asthma Trial of Home Exercises for Teenagers

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