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Идёт набор NCT06447974

The Barts Charity Children's Environmental Health Clinic

Без фазы С лечением Environmental Exposure Health Behavior Asthma in Children Environmental Illness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Exposure mitigations.
Кому может быть актуально
Состояния в реестре: Environmental Exposure, Health Behavior, Asthma in Children, Environmental Illness. Базовые параметры: 4 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Clinical investigations will be performed as part of the clinic. This will include blood eosinophils, FeNO, salivary cotinine and custom mould sensitivity. These investigations will be performed by medical members of staff during clinic visits. The results of these tests will be recorded in the medical notes, as well as in the digital database and secure in the servers based at Barts Health

Home assessments: During the period of home monitoring, participants will undergo assessments of their homes, their personal exposure to pollutants and undergo further health monitoring through the monitoring period. The home assessment will review mould and include a custom mould test comparing the child's blood IgG with a scraping from the mould in their home. The assessment of personal exposure will be performed using the Atmotube air quality monitor attached to a backpack (this is not a medical device). This monitor will be kept with the child at home, on their commutes and also at school. The portable air quality monitor measures air concentrations of particulate matter and volatile organic compounds (VOCs), humidity, temperature as well as GPS data and compares this against time. The encrypted anonymous data is then uploaded to a secure API before being stored within secure databases within the Barts health NHS servers. This database is stored securely within protected servers. No personal identifiable data or demographics is shared with Atmo or any other team otuside the clinic team.

After initial data collection and the home monitoring period, the data is collated and analysed by a medical member of the team to create a personal exposure report for each participant. This report will be provided to the participant, saved in the medical records, and used to recommend any appropriate exposure mitigation strategies. Follow up reviews will repeat the monitoring process and update the database, to compare the results before and after mitigation strategies have been introduced.

Вмешательства

  • Поведенческое Exposure mitigations
    Behavioural interventions with an aim to reduce exposure by targeting occurrences of high exposure

Первичные конечные точки

  • 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. [Срок оценки: 3 years]
Вторичные конечные точки (8)
  • What is the environmental exposure of children attending the environmental health clinic? [Срок оценки: 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? [Срок оценки: 3 years]
  • At which locations and times of day are children exposed to the most air pollution? [Срок оценки: 3 years]
  • Does exposure to indoor and outdoor air pollution follow a repeated pattern each day? [Срок оценки: 3 years]
  • Which factors affect the levels of environmental exposure to pollutants? [Срок оценки: 3 years]
  • How does exposure to pollutants affect the health of children and young people with chronic respiratory disease? [Срок оценки: 3 years]
  • Which mitigation strategies are effective in reducing the effects of pollution exposure and in which patients are they efficacious? [Срок оценки: 3 years]
  • Is an NHS environmental health clinic effective in delivering improvements in respiratory health of children with chronic respiratory disease? [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Великобритания · 2 центра
  • Queen Mary University of London — London
  • The Royal London Hospital — London

Публикации

  • Brook RD, Rajagopalan S, Pope CA 3rd, Brook JR, Bhatnagar A, Diez-Roux AV, Holguin F, Hong Y, Luepker RV, Mittleman MA, Peters A, Siscovick D, Smith SC Jr, Whitsel L, Kaufman JD; American Heart Association Council on Epidemiology and Prevention, Council on the Kidney in Cardiovascular Disease, and Council on Nutrition, Physical Activity and Metabolism. Particulate matter air pollution and cardiova PMID 20458016
  • Kampa M, Castanas E. Human health effects of air pollution. Environ Pollut. 2008 Jan;151(2):362-7. doi: 10.1016/j.envpol.2007.06.012. Epub 2007 Jul 23. PMID 17646040
  • GBD 2016 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1345-1422. doi: 10.1016/S0140-6736(17)32366-8. PMID 28919119
  • Sram RJ, Binkova B, Dejmek J, Bobak M. Ambient air pollution and pregnancy outcomes: a review of the literature. Environ Health Perspect. 2005 Apr;113(4):375-82. doi: 10.1289/ehp.6362. PMID 15811825
  • Brugha R, Grigg J. Urban air pollution and respiratory infections. Paediatr Respir Rev. 2014 Jun;15(2):194-9. doi: 10.1016/j.prrv.2014.03.001. Epub 2014 Mar 12. PMID 24704510
  • Gehring U, Wijga AH, Koppelman GH, Vonk JM, Smit HA, Brunekreef B. Air pollution and the development of asthma from birth until young adulthood. Eur Respir J. 2020 Jul 2;56(1):2000147. doi: 10.1183/13993003.00147-2020. Print 2020 Jul. PMID 32299858
  • Lacasana M, Esplugues A, Ballester F. Exposure to ambient air pollution and prenatal and early childhood health effects. Eur J Epidemiol. 2005;20(2):183-99. doi: 10.1007/s10654-004-3005-9. PMID 15792286
  • Li X, Huang S, Jiao A, Yang X, Yun J, Wang Y, Xue X, Chu Y, Liu F, Liu Y, Ren M, Chen X, Li N, Lu Y, Mao Z, Tian L, Xiang H. Association between ambient fine particulate matter and preterm birth or term low birth weight: An updated systematic review and meta-analysis. Environ Pollut. 2017 Aug;227:596-605. doi: 10.1016/j.envpol.2017.03.055. Epub 2017 Apr 28. PMID 28457735

Идентификаторы

NCT: NCT06447974 · 325076

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗