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临床试验/NCT05006703
NCT05006703已完成不适用

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

University of Southampton2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Asthma-specific Quality of Life

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Asthma-specific Quality of Life

时间窗: 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.

Asthma Control

时间窗: 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.

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

时间窗: 6 months

Self-reported in a healthcare utilisation questionnaire.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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