AllergyALLUKNNCT03826953
Allergy UK Research and Development Nurse Project
A study testing Nurse Led Allergy Clinic in people with Allergy, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
The aim of the research project is to develop, deliver and assess the feasibility of a nurse-led allergy clinic in primary care, taking into account population, geographical area and needs of healthcare in the area chosen. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Allergy
- What is being tested?
- Nurse Led Allergy Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2017to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All children, young people and adults who fit the selection criteria from across all the practices can be referred to the allergy clinic.
- All patients and parents / carers where appropriate must be deemed capable of giving informed consent to take part in the research project.
- Infants under two with suspected food allergy
- Infants under two with moderate-to-severe eczema not responding to standard treatment.
- Children and young people (up to 16 years of age) with suspected allergic rhinitis symptoms that are unresponsive to a combination of oral antihistamines and nasal steroids
- Young people and adults (from 16 years of age) with a history of anaphylaxis or suspected anaphylaxis
Who cannot join
- Over 2 years of age with delayed type food allergy presenting primarily with gastrointestinal symptoms
- Over 2 years of age with confirmed non IgE-mediated symptoms including food intolerances, coeliac disease etc.
- Single urticarial reactions without an obvious triggers
- Non-allergic chronic urticaria
- Drug allergy
- Well controlled allergic rhinitis, asthma or atopic eczema
- Mild-to-moderate atopic eczema without an obvious allergic trigger
- Localised insect sting reactions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Of Edinburgh Health Centre
Edinburgh, EH8 9AL
About this study
Official title: Allergy UK Research and Development Nurse. Developing and Evaluating the Impact of a Nurse-led Primary Care-based Allergy Clinic in NHS Lothian: a Mixed Methods Pilot Study
The aim of the research project is to develop, deliver and assess the feasibility of a nurse-led allergy clinic in primary care, taking into account population, geographical area and needs of healthcare in the area chosen. It is widely acknowledged that the majority of cases of mild to moderate allergy could be adequately dealt with in primary care, by a healthcare professional with the appropriate expertise and knowledge of allergy. The provision of allergy care in the community could potentially have a beneficial impact on health care and patient outcomes.
The project will comprise the set up and delivery of a nurse led allergy clinic in primary care and use a mix of qualitative and quantitative methods to evaluate the feasibility of the clinic. This will include the use of a series of validated questionnaires e.g. satisfaction, condition specific quality of life and economic cost questionnaires, as well as face to face interviews.
The research will collect data to see if this clinical intervention is feasible and allow audit of the clinical intervention. This will also enable the researchers to understand patients lived experiences of accessing allergy care and the effect of allergy on quality of life and impact of allergy care.
Read the detailed description
The study will consist of the development and delivery of a nurse led clinical intervention to provide allergy care in the community within the NHS Lothian primary care setting. The clinical intervention will see the allergy nurse provide clinical care to patients with a specified range of allergic conditions and provide diagnosis and immediate management where appropriate.
The clinical component of the research project will consist of a pilot nurse led allergy clinic, provided by one specialist nurse twice a week across two different GP surgeries within NHS Lothian, GPs from across 12 practices will be encouraged to refer into the pilot allergy clinic.
The referring health care professional will advise participants and their carers that the nurse led allergy clinic has been set up as part of a research project and participants will be asked if they wish to consent to take part in the research study. Feedback on the pilot clinic will be gathered to find out if the pilot clinic is acceptable to participants (satisfaction questionnaire), to find out if the clinic has made any improvement to quality of life (condition specific quality of life questionnaire) and if there is any cost impact (cost questionnaire).
Participants The initial consultation - explanation of research project and written informed consent obtained.
The nurse practitioner will:
- Take a thorough allergy clinical history including examination of the participant as necessary and identify what clinical care is required,
- Carry out any investigations that are required eg Skin prick testing to common food and aeroallergens.
- Give advice both written and verbal to support the management of allergies, including demonstration of medical devices e.g. adrenaline auto injectors, inhalers etc.
- Prescribe any necessary medication
- Provide a written summary of the consultation and any prescribed medication.
Participants will complete a series of three questionnaires, satisfaction, condition specific quality of life and cost questionnaires.
Follow up appointments where deemed appropriate will be conducted by telephone using a specified protocol. Where this is not appropriate face to face reviews will be arranged during clinic time. While short term follow-ups will be provided, there are no facilities to offer long term follow up for participants attending the allergy clinic under this pilot and all participants will return to their health care professional for follow up and long term management. If the participant has complex allergies or requires specialist intervention the participant will be advised that they will require referral into secondary care.
As part of the research project an email support service will be set up to support the health care professionals involved in the project.
The study will utilize a combination of qualitative and quantitative methods to evaluate the clinical intervention at baseline and at six weeks to determine the feasibility of the clinic and patient outcomes with this clinical intervention.
The tools available to the researcher include a series of validated surveys including patient and clinician satisfaction surveys, condition specific quality of life and economic cost to patient.
Interviews In addition face to face interviews will be offered to a subset of participants to enable further understanding of their perspective and experiences of the nurse-led allergy clinic. This will be to see if this intervention is feasible and improves patient care.
The views of health care professionals and practice managers referring into this clinic will also be sought using a satisfaction questionnaire and qualitative interviews at 12 weeks after the start of the clinic and 10-12 months from the end of the project.
Data on allergy will be requested from GP practices and NHS Information services Division (ISD) for quantitative analysis at baseline and at the end of the study.
- Conditions
- Allergy
- Being tested
- Nurse Led Allergy Clinic
- Keywords
- nurse led allergy clinic
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Led Allergy ClinicOther
Project to investigate if it is feasible to establish a nurse-led primary care-based allergy clinic intervention in NHS Lothian, and to understand the acceptability and estimate the impact of this service on improving access and outcomes in patients with allergic conditions.WE will undertake a mixed-methods longitudinal evaluation of the community-based nurse-led allergy clinic.
| Study group | Role | What they receive |
|---|---|---|
| Nurse led allergy clinic | Other | nurse led allergy clinic Receives: Other: Nurse Led Allergy Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire,in patients
The questionnaire will measure the number of patients who had a positive or negative experience within the clinic using the satisfaction questionnaire at initial consultation then again at review
Measured: 3 year feasibility study
To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire in primary care
The questionnaire will measure health care professionals experience of referring patients into the clinic using the satisfaction questionnaire
Measured: 3 year feasibility study
To find out if a nurse-led clinic in primary care is feasible measured using a validated health economics survey
The Health economics survey will measure the cost of attending the clinic in terms of travel and loss of working or education hours required to attend the clinic.
Measured: 3 year feasibility study
To find out if a nurse-led clinic in primary care is feasible measured using qualitative interviews
Qualitative interviews will be used to find out patients and health care professionals experience of using the nurse led allergy clinic, interview will be transcribed and analysed using Nvivo.
Measured: 3 year feasibility study
Secondary outcomes (5)
Measure quality of life in patients using validated disease specific quality of life questionnaires Infants Dermatology Quality of Life Index IDQOL
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for infants with dermatology. Scoring system is via a 4 point satisfaction scale none (no impact) =0 severe = 4
Measured: 3 Years
Measure quality of life in patients validated disease specific quality of life questionnaires Mini Rhinitis Quality of Life Questionnaire (mini RQLQ)
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire to measure the impact of allergic rhinitis using a satisfaction scoring system no impact 0 - extreme = 4
Measured: 3 Years
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Adult Form - (FAQLQ - AF)
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for adults with food allergy, using a specially designed nummular 6 point rating scoring system where 0== no impact 3= moderate impact and 6 = extreme impact on quality of life
Measured: 3 Years
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Teenagers Form (FAQLQ - TF)
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for teenagers with food allergy. Scoring system using a specially designed nummular 6 point rating scoring system where 0== no impact 3= moderate impact and 6 = extreme impact on quality of life
Measured: 3 Years
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality Of Life Questionnaire - Parents Form (FAQLQ - PF)
Will be used to determine if there is an improvement in a patients quality of life after attending the clinic this will be assessed using a validated quality of life questionnaire specifically designed for parents with children under 12 with food allergy. Scoring system using a specially designed nummular 6 point scoring system where 0== no impact 3= moderate impact and 6 = extreme impact on quality of life
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start4 Jul 2017
- Primary completion31 Dec 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is to determine the feasibility of a nurse led allergy clinic, delivered by specialist allergy nurse in primary care, using a hub and spoke model for the delivery of the clinic, the hub being the 'host' centre of GP practice and the spokes being the local / neighbouring GP practices that refer into the 'host' centre. Participants will be identified and recommended through their usual health care provider and referred into the clinic. Data will be collected through a mixed methods approach using questionnaires, interviews and national and locally held data to evaluate the effectiveness of the clinic.
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Allergy UK
- Responsible party
- Sponsor
- Investigators
- Aziz Sheikh, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826953
- Sponsor's protocol ID
- AC17008
- Acronym
- ALLUKN
- Status last verified
- Jan 2019
- First submitted
- 22 May 2017
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anandan C, Gupta R, Simpson CR, Fischbacher C, Sheikh A. Epidemiology and disease burden from allergic disease in Scotland: analyses of national databases. J R Soc Med. 2009 Oct;102(10):431-42. doi: 10.1258/jrsm.2009.090027.
PubMed 19797601Ben-Shoshan M, Soller L, Harrington DW, Knoll M, La Vieille S, Fragapane J, Joseph L, St Pierre Y, Wilson K, Elliott SJ, Clarke AE. Eczema in early childhood, sociodemographic factors and lifestyle habits are associated with food allergy: a nested case-control study. Int Arch Allergy Immunol. 2015;166(3):199-207. doi: 10.1159/000381829. Epub 2015 Apr 22.
PubMed 25926095Cummings AJ, Knibb RC, King RM, Lucas JS. The psychosocial impact of food allergy and food hypersensitivity in children, adolescents and their families: a review. Allergy. 2010 Aug;65(8):933-45. doi: 10.1111/j.1398-9995.2010.02342.x. Epub 2010 Feb 22.
PubMed 20180792Dhami S, Sheikh A. Estimating the prevalence of aero-allergy and/or food allergy in infants, children and young people with moderate-to-severe atopic eczema/dermatitis in primary care: multi-centre, cross-sectional study. J R Soc Med. 2015 Jun;108(6):229-36. doi: 10.1177/0141076814562982. Epub 2015 Jan 7.
PubMed 25567768Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.
PubMed 15080802Jutel M, Angier L, Palkonen S, Ryan D, Sheikh A, Smith H, Valovirta E, Yusuf O, van Wijk RG, Agache I. Improving allergy management in the primary care network--a holistic approach. Allergy. 2013 Nov;68(11):1362-9. doi: 10.1111/all.12258. Epub 2013 Oct 11.
PubMed 24117436Levy ML, Walker S, Woods A, Sheikh A. Service evaluation of a UK primary care-based allergy clinic: quality improvement report. Prim Care Respir J. 2009 Dec;18(4):313-9. doi: 10.4104/pcrj.2009.00042.
PubMed 19588053MacKenzie H, Roberts G, van Laar D, Dean T. Teenagers' experiences of living with food hypersensitivity: a qualitative study. Pediatr Allergy Immunol. 2010 Jun;21(4 Pt 1):595-602. doi: 10.1111/j.1399-3038.2009.00938.x. Epub 2009 Aug 21.
PubMed 19702674Pereira B, Venter C, Grundy J, Clayton CB, Arshad SH, Dean T. Prevalence of sensitization to food allergens, reported adverse reaction to foods, food avoidance, and food hypersensitivity among teenagers. J Allergy Clin Immunol. 2005 Oct;116(4):884-92. doi: 10.1016/j.jaci.2005.05.047.
PubMed 16210065Punekar YS, Sheikh A. Establishing the incidence and prevalence of clinician-diagnosed allergic conditions in children and adolescents using routinely collected data from general practices. Clin Exp Allergy. 2009 Aug;39(8):1209-16. doi: 10.1111/j.1365-2222.2009.03248.x. Epub 2009 Apr 17.
PubMed 19400899Tejedor-Alonso M A, Moro-Moro M, Mugica-Garcia MV. Epidemiology of Anaphylaxis: Contributions From the Last 10 Years. J Investig Allergol Clin Immunol. 2015;25(3):163-75; quiz follow 174-5.
PubMed 26182682Scadding GK, Durham SR, Mirakian R, Jones NS, Leech SC, Farooque S, Ryan D, Walker SM, Clark AT, Dixon TA, Jolles SR, Siddique N, Cullinan P, Howarth PH, Nasser SM; British Society for Allergy and Clinical Immunology. BSACI guidelines for the management of allergic and non-allergic rhinitis. Clin Exp Allergy. 2008 Jan;38(1):19-42. doi: 10.1111/j.1365-2222.2007.02888.x.
PubMed 18081563Smith HE, Wade J, Frew AJ. What proportion of adult allergy referrals to secondary care could be dealt with in primary care by a GP with special interest? Clin Transl Allergy. 2016 Jan 21;6:3. doi: 10.1186/s13601-016-0091-1. eCollection 2015.
PubMed 26807213Hammersley V, Kelman M, Morrice L, Kendall M, Mukerjhee M, Harley S, Schwarze J, Sheikh A. Mixed-methods evaluation of a nurse-led allergy clinic model in primary care: Feasibility trial. Clin Transl Allergy. 2022 Aug;12(8):e12180. doi: 10.1002/clt2.12180.
PubMed 36036238
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergy UK Research and Development Nurse. Developing and Evaluating the Impact of a Nurse-led Primary Care-based Allergy Clinic in NHS Lothian: a Mixed Methods Pilot Study
- ClinicalTrials.gov ID
- NCT03826953
- Acronym / sponsor ID
- ALLUKN / AC17008
- Conditions
- Allergy
- Keywords
- nurse led allergy clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Allergy UK
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the research project is to develop, deliver and assess the feasibility of a nurse-led allergy clinic in primary care, taking into account population, geographical area and needs of healthcare in the area chosen. It is widely acknowledged that the majority of cases of mild to moderate allergy could be adequately dealt with in primary care, by a healthcare professional with the appropriate expertise and knowledge of allergy. The provision of allergy care in the community could potentially have a beneficial impact on health care and patient outcomes.
The project will comprise the set up and delivery of a nurse led allergy clinic in primary care and use a mix of qualitative and quantitative methods to evaluate the feasibility of the clinic. This will include the use of a series of validated questionnaires e.g. satisfaction, condition specific quality of life and economic cost questionnaires, as well as face to face interviews.
The research will collect data to see if this clinical intervention is feasible and allow audit of the clinical intervention. This will also enable the researchers to understand patients lived experiences of accessing allergy care and the effect of allergy on quality of life and impact of allergy care.
Detailed description
The study will consist of the development and delivery of a nurse led clinical intervention to provide allergy care in the community within the NHS Lothian primary care setting. The clinical intervention will see the allergy nurse provide clinical care to patients with a specified range of allergic conditions and provide diagnosis and immediate management where appropriate.
The clinical component of the research project will consist of a pilot nurse led allergy clinic, provided by one specialist nurse twice a week across two different GP surgeries within NHS Lothian, GPs from across 12 practices will be encouraged to refer into the pilot allergy clinic.
The referring health care professional will advise participants and their carers that the nurse led allergy clinic has been set up as part of a research project and participants will be asked if they wish to consent to take part in the research study. Feedback on the pilot clinic will be gathered to find out if the pilot clinic is acceptable to participants (satisfaction questionnaire), to find out if the clinic has made any improvement to quality of life (condition specific quality of life questionnaire) and if there is any cost impact (cost questionnaire).
Participants The initial consultation - explanation of research project and written informed consent obtained.
The nurse practitioner will:
- Take a thorough allergy clinical history including examination of the participant as necessary and identify what clinical care is required,
- Carry out any investigations that are required eg Skin prick testing to common food and aeroallergens.
- Give advice both written and verbal to support the management of allergies, including demonstration of medical devices e.g. adrenaline auto injectors, inhalers etc.
- Prescribe any necessary medication
- Provide a written summary of the consultation and any prescribed medication.
Participants will complete a series of three questionnaires, satisfaction, condition specific quality of life and cost questionnaires.
Follow up appointments where deemed appropriate will be conducted by telephone using a specified protocol. Where this is not appropriate face to face reviews will be arranged during clinic time. While short term follow-ups will be provided, there are no facilities to offer long term follow up for participants attending the allergy clinic under this pilot and all participants will return to their health care professional for follow up and long term management. If the participant has complex allergies or requires specialist intervention the participant will be advised that they will require referral into secondary care.
As part of the research project an email support service will be set up to support the health care professionals involved in the project.
The study will utilize a combination of qualitative and quantitative methods to evaluate the clinical intervention at baseline and at six weeks to determine the feasibility of the clinic and patient outcomes with this clinical intervention.
The tools available to the researcher include a series of validated surveys including patient and clinician satisfaction surveys, condition specific quality of life and economic cost to patient.
Interviews In addition face to face interviews will be offered to a subset of participants to enable further understanding of their perspective and experiences of the nurse-led allergy clinic. This will be to see if this intervention is feasible and improves patient care.
The views of health care professionals and practice managers referring into this clinic will also be sought using a satisfaction questionnaire and qualitative interviews at 12 weeks after the start of the clinic and 10-12 months from the end of the project.
Data on allergy will be requested from GP practices and NHS Information services Division (ISD) for quantitative analysis at baseline and at the end of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is to determine the feasibility of a nurse led allergy clinic, delivered by specialist allergy nurse in primary care, using a hub and spoke model for the delivery of the clinic, the hub being the 'host' centre of GP practice and the spokes being the local / neighbouring GP practices that refer into the 'host' centre. Participants will be identified and recommended through their usual health care provider and referred into the clinic. Data will be collected through a mixed methods approach using questionnaires, interviews and national and locally held data to evaluate the effectiveness of the clinic.
| Arm | Type | Receives |
|---|---|---|
| Nurse led allergy clinic | Other | Other: Nurse Led Allergy Clinicnurse led allergy clinic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- All children, young people and adults who fit the selection criteria from across all the practices can be referred to the allergy clinic.
- All patients and parents / carers where appropriate must be deemed capable of giving informed consent to take part in the research project.
- Infants under two with suspected food allergy
- Infants under two with moderate-to-severe eczema not responding to standard treatment.
- Children and young people (up to 16 years of age) with suspected allergic rhinitis symptoms that are unresponsive to a combination of oral antihistamines and nasal steroids
Key exclusion criteria (8 listed)
- Over 2 years of age with delayed type food allergy presenting primarily with gastrointestinal symptoms
- Over 2 years of age with confirmed non IgE-mediated symptoms including food intolerances, coeliac disease etc.
- Single urticarial reactions without an obvious triggers
- Non-allergic chronic urticaria
- Drug allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse Led Allergy ClinicProject to investigate if it is feasible to establish a nurse-led primary care-based allergy clinic intervention in NHS Lothian, and to understand the acceptability and estimate the impact of this service on improving access and outcomes in patients with allergic conditions.WE will undertake a mixed-methods longitudinal evaluation of the community-based nurse-led allergy clinic. | Other | Nurse led allergy clinic |
Primary outcome
To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire,in patients
Time frame: 3 year feasibility study
The questionnaire will measure the number of patients who had a positive or negative experience within the clinic using the satisfaction questionnaire at initial consultation then again at review
To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire in primary care
Time frame: 3 year feasibility study
The questionnaire will measure health care professionals experience of referring patients into the clinic using the satisfaction questionnaire
To find out if a nurse-led clinic in primary care is feasible measured using a validated health economics survey
Time frame: 3 year feasibility study
The Health economics survey will measure the cost of attending the clinic in terms of travel and loss of working or education hours required to attend the clinic.
To find out if a nurse-led clinic in primary care is feasible measured using qualitative interviews
Time frame: 3 year feasibility study
Qualitative interviews will be used to find out patients and health care professionals experience of using the nurse led allergy clinic, interview will be transcribed and analysed using Nvivo.
5 secondary outcomes
Measure quality of life in patients using validated disease specific quality of life questionnaires Infants Dermatology Quality of Life Index IDQOL
Time frame: 3 Years
Measure quality of life in patients validated disease specific quality of life questionnaires Mini Rhinitis Quality of Life Questionnaire (mini RQLQ)
Time frame: 3 Years
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Adult Form - (FAQLQ - AF)
Time frame: 3 Years
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Teenagers Form (FAQLQ - TF)
Time frame: 3 Years
Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality Of Life Questionnaire - Parents Form (FAQLQ - PF)
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 19797601Anandan C, Gupta R, Simpson CR, Fischbacher C, Sheikh A. Epidemiology and disease burden from allergic disease in Scotland: analyses of national databases. J R Soc Med. 2009 Oct;102(10):431-42. doi: 10.1258/jrsm.2009.090027.
- Background: PubMed 25926095Ben-Shoshan M, Soller L, Harrington DW, Knoll M, La Vieille S, Fragapane J, Joseph L, St Pierre Y, Wilson K, Elliott SJ, Clarke AE. Eczema in early childhood, sociodemographic factors and lifestyle habits are associated with food allergy: a nested case-control study. Int Arch Allergy Immunol. 2015;166(3):199-207. doi: 10.1159/000381829. Epub 2015 Apr 22.
- Background: PubMed 20180792Cummings AJ, Knibb RC, King RM, Lucas JS. The psychosocial impact of food allergy and food hypersensitivity in children, adolescents and their families: a review. Allergy. 2010 Aug;65(8):933-45. doi: 10.1111/j.1398-9995.2010.02342.x. Epub 2010 Feb 22.
- Background: PubMed 25567768Dhami S, Sheikh A. Estimating the prevalence of aero-allergy and/or food allergy in infants, children and young people with moderate-to-severe atopic eczema/dermatitis in primary care: multi-centre, cross-sectional study. J R Soc Med. 2015 Jun;108(6):229-36. doi: 10.1177/0141076814562982. Epub 2015 Jan 7.
- Background: PubMed 15080802Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.
- Background: PubMed 24117436Jutel M, Angier L, Palkonen S, Ryan D, Sheikh A, Smith H, Valovirta E, Yusuf O, van Wijk RG, Agache I. Improving allergy management in the primary care network--a holistic approach. Allergy. 2013 Nov;68(11):1362-9. doi: 10.1111/all.12258. Epub 2013 Oct 11.
- Background: PubMed 19588053Levy ML, Walker S, Woods A, Sheikh A. Service evaluation of a UK primary care-based allergy clinic: quality improvement report. Prim Care Respir J. 2009 Dec;18(4):313-9. doi: 10.4104/pcrj.2009.00042.
- Background: PubMed 19702674MacKenzie H, Roberts G, van Laar D, Dean T. Teenagers' experiences of living with food hypersensitivity: a qualitative study. Pediatr Allergy Immunol. 2010 Jun;21(4 Pt 1):595-602. doi: 10.1111/j.1399-3038.2009.00938.x. Epub 2009 Aug 21.
- Background: PubMed 16210065Pereira B, Venter C, Grundy J, Clayton CB, Arshad SH, Dean T. Prevalence of sensitization to food allergens, reported adverse reaction to foods, food avoidance, and food hypersensitivity among teenagers. J Allergy Clin Immunol. 2005 Oct;116(4):884-92. doi: 10.1016/j.jaci.2005.05.047.
- Background: PubMed 19400899Punekar YS, Sheikh A. Establishing the incidence and prevalence of clinician-diagnosed allergic conditions in children and adolescents using routinely collected data from general practices. Clin Exp Allergy. 2009 Aug;39(8):1209-16. doi: 10.1111/j.1365-2222.2009.03248.x. Epub 2009 Apr 17.
- Background: PubMed 26182682Tejedor-Alonso M A, Moro-Moro M, Mugica-Garcia MV. Epidemiology of Anaphylaxis: Contributions From the Last 10 Years. J Investig Allergol Clin Immunol. 2015;25(3):163-75; quiz follow 174-5.
- Background: PubMed 18081563Scadding GK, Durham SR, Mirakian R, Jones NS, Leech SC, Farooque S, Ryan D, Walker SM, Clark AT, Dixon TA, Jolles SR, Siddique N, Cullinan P, Howarth PH, Nasser SM; British Society for Allergy and Clinical Immunology. BSACI guidelines for the management of allergic and non-allergic rhinitis. Clin Exp Allergy. 2008 Jan;38(1):19-42. doi: 10.1111/j.1365-2222.2007.02888.x.
- Individual participant dataSharing planned: No
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Dysphagia, Eosinophilic Esophagitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aziz Sheikh principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Led Allergy Clinic in people with Allergy, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire,in patients (time frame: 3 year feasibility study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03826953, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.