Determining the Effectiveness of a FeNO-guided asthma management INtervEntion in primary care (DEFINE) is a research study conducted by the University of Oxford.
Its aim is to help health care professionals in GP surgeries provide a more personalised approach to managing patients’ asthma by using FeNO to guide decisions about their treatment.
FeNO stands for fractional exhaled nitric oxide and is measured using a simple breath test.
Nitric oxide is a gas which everyone breathes out. People with inflamed airways breathe out more nitric oxide than people whose airways are not inflamed. These patients are more likely to have an asthma attack if their inflammation remains untreated.
FeNO is already measured in patients with severe asthma who are seen in hospital clinics. However, very few GP surgeries routinely use FeNO to help them monitor treatment.
A copy of the Research Information Sheet can be emailed to you on request by getting in touch through our contact form
Measuring Loneliness (INTERACT) Study
Identifying the Prevalence of Social Isolation & Loneliness in the Community Setting Across England
You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish.
*Any mention of ‘we’ refers to the sponsor (Imperial College London) and not the local site.
• You are invited to participate in a study the prevalence of social isolation & loneliness (SI&L) in the community setting including NHS patients & NHS staff. The main purpose of the interviews is to identify possible interventions that could help tackle social isolation & loneliness (SI&L) in the contemporary setting.
• You will be asked to participate in a short (5 minutes) electronic survey and at the end of the survey you will have the option to indicate if you are interested in taking part in a semi-structured 1-2-1 interview (via telephone, Skype or Microsoft teams) that is expected to last about 30-45 minutes so we can learn about your understanding or experience with SI&L. We are only looking to interview 10-15 participants.
• Ask us if there is anything that is not clear or if you would like more information. Please take time to decide whether or not you wish to take part.
Thank you for reading this.
What is the purpose of the study?
The study seeks to measure the prevalence of social isolation & loneliness (SI&L) in the community setting including in NHS patients & NHS staff.
Why have I been chosen?
We are inviting you because you aged 16 years or over, live in the UK and are registered at your NHS GP. The interviewees will be chosen so that a range of ages, ethnicities and genders are included. We are expecting a large volume of responses, therefore we may not be able to follow up with you.
Do I have to take part?
No, it is entirely up to you. If you would like to take part in the survey you will provide consent by indicating this at the beginning of the survey by ticking ‘yes’ to Q2 of the survey which asks for your consent. If you decide to take part in the interview you will be given this information sheet to keep and be asked to sign a consent form. Even after you consent and agree to take part in the study, you are free to withdraw from the study at any time without giving a reason. If you withdraw from the survey or interview, data already gathered at the point of withdrawal will be retained. This is in order to protect the validity of the research and is permissible as an exemption to data subject rights under GDPR.
What will happen if I take part?
You will be asked to take part in a short electronic survey which will take about 5 minutes to complete and at the end of the survey in the last question you will have opportunity to indicate if you would like to also take part in a 30-45 minute 1-2-1 interview (via telephone, Skype or Microsoft Teams). If you leave your contact details for an interview, the study team will contact you to organise a date and time for your interview, you will also be sent a consent form for interview which you will sign and return via email prior to the interview. During the interview, you will be asked open questions about your understanding on social isolation & loneliness, and the UCLA-3 item Loneliness scale (UCLATILS) & ONS Direct Measure of Loneliness (DMOL). Our survey is collecting data on your age, gender, ethnicity, postcode, employment status, marital status, number of people in household & disability status ).
This data will not be used to identify you and we will keep any and all data you provide us secure. The interviews will be audio recorded & video recorded using Microsoft Teams or Zoom. Anonymised quotes from participants will be used in the report or publication. With your permission, the study will be audio-recorded to help us get the most from the interview. You will have the choice of leaving your camera on or off during the interview, and if you choose to keep it on the recording will include your face, however we would like to assure you that only the minimum of data required for the research will be kept securely and that all recordings and transcripts will be stored securely on password protected Imperial College London Sharepoint Drive which can only be accessed by designated members of the research team. Recordings will be deleted immediately after auto-transcription. Only designated members of the study team will be able to access or review the study information on a secure online environment. This will be the extent of your involvement. The interview will be carried out by the research team and will be scheduled at a time convenient for you (usually during office hours: 9am-5pm).
What do I have to do?
There are no added requirements or restrictions associated with this research other than completing the survey on the Qualtrics platform and/or interview.
What are the possible disadvantages and risks of taking part?
We will only collect the minimum amount of data about you required for the study and all data collected will be kept securely so as to protect the confidentiality of all participants. You will also be asked questions which may be of a sensitive nature, however you will be reminded that you can leave the interview at any point or not answer any questions you do not want to.
Participants will also be informed that the interviews will be video and/or audio recorded to facilitate transcription, after which the audio and/or video recording will be immediately destroyed. The anonymised transcripts will be stored on a secure password-protected encrypted Imperial College London servers. We will obtain consent to video & audio record and transcribe the interviews and for the use of anonymised quotes in any report or publication.
We will not have access to any personal or medical data that is not provided by you. The only data we will have access to is that we collect from our eSurvey and through one-to-one interviews.
We are keen to signpost you to some useful links for advice. Examples include:
If you are feeling lonely, socially isolated, or are in danger of harming yourself, please get support from any of the suggested helplines below.
o 116 123
• Mind’s How to cope with loneliness
o 0300 123 3393
• The Mix
o 0808 808 4994
o 0808 2000 247
• Age UK
o 0800 055 6112
• Friends of the elderly
o 0330 332 1110
What are the possible benefits of taking part?
Although this study may not directly benefit you, the findings will be extremely helpful in shaping our understanding of the prevalence & severity of social isolation & loneliness (SI&L) to help identify possible interventions that could help tackle SI&L in the community setting. This research would also help facilitate future discussion and design of primary care services in your Borough.
What happens when the research study stops?
Participants will have the option on competing an eSurvey and/or an interview; this will be the extent to your participation in the study. Participants are welcomed to contact the study team for more information on the study or on the publication.
What if something goes wrong?
If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator (Austen El-Osta; email@example.com). If you are still not satisfied with the response, you may contact the Imperial College, firstname.lastname@example.org.
Imperial College London is the sponsor for this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Imperial College London will keep your personal data for:
• 10 years after the study has finished in relation to data subject consent forms.
• 10 years after the study has completed in relation to primary research data.
If the interviewer believes that an interviewee is at risk of serious harm or that there is a substantial risk of harm to any children or other person, they will primarily encourage the interviewee to receive support (including from police/ helpline services/ Accident & Emergency). If the interviewee refuse this, then the GP has a duty of care to report to relevant authorities including the police or safeguarding services. This only occurs in exceptional circumstances, where there is immediate danger, and only if the individual refuses to contact services. It is the responsibility of the researcher to report instances of risk and to self and others.
In this research study we will use information from you. We will only use information that we need for the research study. Access to your contact details will be limited to the research team.
Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. At the end of the study we will save some of the data in case we need to check it and if you consent, for future research. We will make sure no-one can work out who you are from the reports we write.
The information sheet tells you more about this.
HOW WILL WE USE INFORMATION ABOUT YOU?
Research Study Title: Identifying the Prevalence of Social Isolation & Loneliness in the Community Setting Across England (INTERACT)
Research study IRAS number: 305483
We will need to use information from you for this research project.
This information will include your
• Email address,
• Full post code,
• Telephone contact,
• Place of work,
• Gender and Ethnicity
People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details.
We will keep all information about you safe and secure.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study. You can contact the study team if they would like to see the results of the study.
As a university we use personally identifiable information to conduct research to improve health, care and services. As a publicly funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study.
Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research
There will be no requirement to transfer information to countries outside the UK (for example, to a research partner).
SHARING YOUR INFORMATION WITH OTHERS
For the purposes referred to in this privacy notice and relying on the bases for processing as set out above, we will share your personal data with certain third parties.
• Other College employees, agents, contractors and service providers (for example, suppliers of printing and mailing services, email communication services or web services, or suppliers who help us carry out any of the activities described above). Our third party service providers are required to enter into data processing agreements with us. We only permit them to process your personal data for specified purposes and in accordance with our policies.
WHAT ARE YOUR CHOICES ABOUT HOW YOUR INFORMATION IS USED?
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
WHERE CAN YOU FIND OUT MORE ABOUT HOW YOUR INFORMATION IS USED
You can find out more about how we use your information:
• At www.hra.nhs.uk/information-about-patients/
• By asking one of the research team
• By sending an email to email@example.com, or
• By ringing us on 0207 594 7604.
If you wish to raise a complaint on how we have handled your personal data, do not hesitate to discuss this with the principal investigator Dr Austen El-Osta at firstname.lastname@example.org or via telephone on 0207 594 7604.
If you would rather speak to a non-member of the team, please contact the Imperial College London’s Data Protection Officer via email at email@example.com, via telephone on 020 7594 3502 and/or via post at Imperial College London, Data Protection Officer, Faculty Building Level 4, London SW7 2AZ.
If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO). The ICO does recommend that you seek to resolve matters with the data controller (us) first before involving the regulator.
What will happen to the results of the research study?
If you are interested in obtaining the results do not hesitate to email firstname.lastname@example.org. You will not be identified in any report/publication.
Who is organising and funding the research?
Imperial College London is the study sponsor. This study is funded by Northwest London Applied Research Collaboration. Imperial College London is the main research Sponsor for this study.
Who has reviewed the study?
This study was given a favourable ethical opinion for conduct in the NHS by the Health Research Authority’s Essex Research Ethics Committee.
Contact for Further Information
Should you have any questions regarding this study please do not hesitate to contact Dr Austen El-Osta at email@example.com or via telephone on 0207 594 7604. Thank you for taking part in this study. A copy of the written information and signed Informed Consent form will be given to you to keep.
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