Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447974
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-04-24
Brief Title:
The Barts Charity Childrens Environmental Health Clinic
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
The Barts Charity Childrens Environmental Health Clinic
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCCEHC
Brief Summary:
The study will be based from a newly formed NHS service the childrens 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
Detailed Description:
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 Barts 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 childs 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 participants 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 childs 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
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 Barts 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 childs 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 participants 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 childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None