The Barts Charity Children's Environmental Health Clinic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- How effective is a specialist NHS environmental health clinic in reducing exposure to environmental contaminants in children with chronic respiratory disease, and what is the change in health outcomes.
研究概览
简要总结
The study will be based from a newly formed NHS service, the children's environmental health service. Participants will be children with a known chronic respiratory condition. Participants will undergo personal environmental exposure monitoring as well as home environmental assessments, before personalised exposure reports will be provided including a summary of their exposure and advising mitigation strategies based on exposure patterns and behaviours. The monitoring will be repeated after introduction of mitigation strategies. This will allow a comparison of the effectiveness of each method of mitigation.
详细描述
Data will be collected from multiple sources during the study, including retrospective medical records and results, as well as data recorded as part of the study. These will include the following sources; Medical records from Royal London (including investigation results), Questionnaire responses, clinical interviews at clinic visits, new clinical investigations and home assessments.
These data will be both quantitative and qualitative. The data will be recorded on bespoke electronic databases, which will be securely stored on servers within the Bart's Health/ QMUL, More information on the collection and storage of each type of data can be found below.
Medical records from Royal London: Relevant clinical information and demographics will be extracted from the NHS electronic medical records as baseline information for the assessment in the environmental health clinic. This will be performed by members of the investigative team. Extracted information will include demographics, medical diagnoses, respiratory history, hospital visit history and clinical investigation results. Investigation results may include lung function, FeNO, blood test results, chest x-ray reports and any other relevant results from the child's medical history.
Questionnaires: Participants or their families will complete and return an Environmental Health Questionnaire which was designed for the purposes of the study. Answers to questions from the environmental health questionnaire will be in the form of multiple choice and short answer written questions. The questionnaire will be repeated throughout the participant's involvement in the clinic at designated points. The data from the questionnaires will be recorded in a digital database, will be created for the purpose of the clinic. This database will be stored securely within Barts Health / QMUL servers.
Medical Reviews: At visits in the clinic, interviews of the participants and their families will take place. This will include detailed medical and social history taking by medical sub investigators and a formal physical examination. To improve standardisation of data collected during interviews, a structured proforma will be developed, to be used while the interviews are being conducted. The data collected during these interviews will be recorded in the medical notes, as well as used to create personalised exposure reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent/Guardian able to provide written informed consent
- •Referral made by paediatric asthma team
- •Child aged 4-17 years at the time of consent to study
- •A diagnosis of a chronic respiratory condition (diagnosis by a medical professional)
- •Contactable for regular follow up by the research team
- •Reasonable level of English language
- •Ability to engage with technology and devices used in the study
排除标准
- •Inability to use the tools and devices in the research study
- •Inability to visit the hospital for the initial hospital visit
- •Inability to allow home environmental assessment
研究组 & 干预措施
Pre and post intervention
A single arm for measurement both pre and post introduction of intervention
干预措施: Exposure mitigations (Behavioral)
结局指标
主要结局
How effective is a specialist NHS environmental health clinic in reducing exposure to environmental contaminants in children with chronic respiratory disease, and what is the change in health outcomes.
时间窗: 3 years
Measurement of the concentrations of common air contaminants (PM1, PM2.5, PM5, PM10, VOCs), the GPs location of areas of high concentration and the behaviours of the individual at times of high and low exposure. For each participant, the social and behavioural factors affecting their exposure will be measured using the environmental health questionnaire (type of accommodation, proximity of school and home to main roads, type of cooking fuel and sprays used in the home, presence or absence of damp or mould, and mode and duration of school commute.
次要结局
- Does exposure to indoor and outdoor air pollution follow a repeated pattern each day?(3 years)
- How does exposure to pollutants affect the health of children and young people with chronic respiratory disease?(3 years)
- What is the environmental exposure of children attending the environmental health clinic?(3 years)
- Are clinical tests such as salivary cotinine, exhaled carbon monoxide or blood eosinophils useful in screening for children who have a high environmental exposure to pollutants?(3 years)
- At which locations and times of day are children exposed to the most air pollution?(3 years)
- Is an NHS environmental health clinic effective in delivering improvements in respiratory health of children with chronic respiratory disease?(3 years)
- Which factors affect the levels of environmental exposure to pollutants?(3 years)
- Which mitigation strategies are effective in reducing the effects of pollution exposure and in which patients are they efficacious?(3 years)