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临床试验/NCT07129616
NCT07129616招募中不适用

Remote Monitoring of Asthma in Children and Young People - Reducing Risk of Asthma Attack Using a Connected Patient Approach

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2025年11月20日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
1
主要终点
Number of asthma attacks

研究概览

简要总结

The objective of this study is to determine whether healthcare data and remotely collected patient data can accurately predict asthma attacks in children and young people aged 5-17 years. The main outcome is:

when using this new system, is there a reduction in asthma attacks compared with a historic average.

The whole population of children and young people with asthma will have routine healthcare data monitored, with a subset of people with high risk asthma asked to participate in a more detail study involving remotely monitored data.

详细描述

Asthma affects approximately 1 in 11 people in the UK. It is one of the few chronic health conditions that affects CYP more than older people. Asthma is a fluctuating condition with periods of stability and periods of poor control. Overall cost to the NHS in the UK is greater than £1 billion per year.

Predicting an asthma attack, where there is loss of symptom control, is often associated with family or life changes and poor adherence. Viral infections, environmental triggers, seasonal changes etc. also upset symptom control and can lead to an attack. This attack, which will need an increase in therapy and may result in a hospital admission, is the end point of a period of loss of symptom control which may be up to a month in development. While adherence to treatment is a major factor influencing risk of attack, there are many underlying complex issues that prevent CYP from adhering to their medication.

Asthma attacks are dangerous. They represent a failure of management and can result in loss of school, lost earnings, loss of confidence, loss of sleep, admission to hospital, requirement for intensive care or, in the worst cases, permanent neurological impairment or death due to lack of oxygen to the brain. Severe outcomes are rare but tragically are considered avoidable. Severe attacks can result in a significant aftermath of anxiety, avoidance of normal life activities and general chronic family worry. There is also a high healthcare cost due to poor asthma control.

The national review of asthma deaths, published in 2014 showed several areas where improvements could be made. One of the key recommendations was the introduction of personalised asthma action plans. These have been used more commonly recently but tend to be static printed documents which do not respond to changes in circumstances. In addition, current healthcare systems are poorly responsive to changes in individuals. Around 50% of those who had fatal asthma attacks were classed as having mild asthma. Those classed as severe (<10%) tend to be looked after in specialised hospital clinics with the rest looked after in primary care. In time some who were classed as severe may become more stable, and some who are considered "mild" may still have severe attacks. According the NRAD data, detecting which patients are at risk of an attack at any point in time cannot be limited to whoever is in the tertiary hospital clinic. A whole population approach is needed to reduce the risk of asthma attacks in all CYP.

There is lack of evidence so far that the findings of the NRAD report have resulted in change. A Nuffield report into the health of young people found that the UK lagged far behind comparable countries in Europe in terms of asthma deaths. While the precise reasons for this are not well understood, the report highlights lack of basic access to healthcare and poor understanding of asthma risks by young people as two most likely factors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Children and Young People with a diagnosis of asthma (coded as asthma or suspected asthma) or a prescription of inhaled corticosteroid in the prior 2 years.

排除标准

  • Alternative non-asthma diagnosis that would require inhaled steroid
  • cystic fibrosis
  • bronchiectasis
  • primary ciliary dyskinaesia

结局指标

主要结局

Number of asthma attacks

时间窗: 6 months

Change in primary care prescriptions for asthma attack medication (Prednisolone or similar) in the population utilising this new system compared with a historical asthma population from the same location.

次要结局

  • Cough data analytics(6 months)
  • Cough free time(6 months)
  • Cough rate correlation with asthma attack rate(6 months)
  • Medication changes(6 months)
  • Cough rate correlation(6 months)
  • Number identified as high risk(6 months)
  • Interventions required(6 months)
  • Number of hospital asthma attacks(6 months)
  • Number of life threatening attacks(6 months)
  • App and dashboard utilisation(6 months)
  • Rate of symptoms reported(6 months)
  • Night time cough rate(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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