Childhood Asthma Management in Primary Care: Implementation Of Exhaled Nitric Oxide and Spirometry Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 613
- 试验地点
- 2
- 主要终点
- Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice
研究概览
简要总结
What are the capacity and training needs in general practice to implement routine spirometry and eNO testing in children aged 5-16 years?
Asthma is the commonest long-term disease of childhood in the United Kingdom (UK). Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been reported from several European countries including the UK. This can result in poor symptom control and increased risk of asthma related deaths.
It has been suggested that both under- and over- diagnosis of childhood asthma in general practice could be improved by routinely using objective lung function testing for diagnosis and monitoring.
The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements - eNO) are already used routinely in UK hospitals, but are not usually available in general practice where most children are cared for.
Why is it important? - Availability of these tests will help health professionals in general practice to look after children with asthma better, and hopefully improve asthma control.
What will this study achieve? - Though it is believed that providing spirometry and eNO in general practice would be beneficial, there is little data on how this can be achieved. This study will employ both qualitative and quantitative measures in order to evaluate the resources required to implement routine spirometry and eNO testing for children in primary care; and to investigate the impact this would have on diagnosis in children with suspected asthma.
How? - The investigators will work with general practices in and around Leicestershire, UK. Firstly, to identify what the barriers are to implementing these tests, and secondly to train the practices to perform and interpret spirometry and eNO independently in children.
Children with suspected or previously diagnosed asthma will be invited for review and lung function testing. The investigators will record the time it takes to train general practices to perform and interpret spirometry and eNO independently, and the additional clinic capacity required to provide these tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On the practice asthma register or
- •Are prescribed regular (on repeat prescription) inhaled corticosteroids including beclometasone, fluticasone and budesonide and also search specifically for 'brands' that are commonly prescribed to include 'clenil', 'seretide', 'symbicort', and 'qvar' or
- •Have been prescribed ≥ 2 Salbutamol MDI's in the last 12 months or
- •Had a documented exacerbation of asthma in the last 12 months
- •Able and willing, in the opinion of the Investigator, to give informed consent
排除标准
- •Children who are unable to perform lung function tests for any reason
- •Children and young people <5 years and >16 years
- •Unable or unwilling, in the opinion of the Investigator, to give informed consent
结局指标
主要结局
Time Needed to Perform Paediatric Spirometry and eNO Testing in General Practice
时间窗: 12 months
Time (minutes) to perform both spirometry and eNO test in children
Number of Children in Whom Usable Spirometry and eNO Data Can be Obtained
时间窗: 12 months
Number of children (out of 612) able to perform objective tests
次要结局
- The Number of Children in Whom a Diagnosis of Asthma Can be Confirmed Using Spirometry and eNO Testing(12 months)
- Change in Paediatric Asthma Quality of Life Questionnaire Score Measured at Enrolment and 3-6 Months Post-enrollment(PAQLQ score was assessed at enrolment and then again at 3-6 months post enrolment)
- Change in Child Health Utility 9D Questionnaire Score Measured at Enrolment and at 3-6 Months Post-enrolment(CHU9D score was assessed at enrolment and then again at 3-6 months post-enrolment.)