跳至主要内容
临床试验/NCT03536416
NCT03536416已完成不适用

Multifaceted Theory-based Self-management Intervention to Improve Adolescents' Asthma Control: A Cluster-randomised Controlled Trial (RCT)

Queen Mary University of London2 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2018年12月18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
330
试验地点
2
主要终点
Asthma control

研究概览

简要总结

Approximately 1.1 million children and young people in the United Kingdom (UK) are living with asthma, making it the most common chronic disease in children in the UK. Our recent observational study found that poor asthma control, poor medication adherence, and a poor understanding of asthma were key unmet needs of secondary school children. Following the findings from an earlier study, the investigators have developed a preliminary theory-based multi-faceted intervention, aimed at improving asthma self-management and control in young people.

详细描述

The investigators have developed a theory-driven self-management intervention for children and young people which addresses the barriers to successful self-management, which were identified in an earlier study. The intervention will engage asthmatic teenagers and their peers, and will be delivered in two components. The first component includes a theatre workshop for all children aged 11-13 years in London secondary schools. The aim of this component is to raise awareness of asthma in schools among peers. The second component is a series of four self-management workshops for children with asthma. The aim of this component is to teach children about asthma, using interactive role plays and games. The main topics will include asthma general knowledge and understanding; General Practitioner (GP) communication; asthma triggers and symptoms; medication and emergency response; and self-management techniques and goal setting. The children will also receive a toolkit to take home with them, which will include a copy of the workbook that they have used during the day, containing information on what they have learnt. There will also be information on where they can get more help for their asthma. The toolkit will also include information about a smartphone gaming app, which will be about asthma knowledge.

研究设计

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

盲法说明

The schools will be randomised, and will not be told which group they have been randomised to.

入排标准

年龄范围
11 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Doctor-diagnosed asthma
  • Aged 11-14 years (UK school years 7-8)
  • Attending the secondary school in which the study is implemented
  • All children in years 7 and 8 in UK secondary schools are eligible to watch the theatre performance

排除标准

  • No diagnosis of asthma
  • Not aged 11-14 years (UK school years 7-8)
  • Not attending the school at the time the intervention is delivered

结局指标

主要结局

Asthma control

时间窗: 15 months

This will be measured using the validated Asthma Control Test. Scores range from 5-25. A score of 19 or below indicates poorly controlled asthma; a score of 20 or above indicates good asthma control.

次要结局

  • Beliefs About Medicines Questionnaire(15 months)
  • Unscheduled care(15 months)
  • Brief-Illness Perception Questionnaire(15 months)
  • School absences(15 months)
  • Asthma knowledge(15 months)
  • Medication Adherence Rating Scale.(15 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Grigg

Professor

Queen Mary University of London

研究点 (2)

Loading locations...

相似试验