Multifaceted Theory-based Self-management Intervention to Improve Adolescents' Asthma Control: A Cluster-randomised Controlled Trial (RCT)
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
- 是
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
Jonathan Grigg
Professor
Queen Mary University of London
