<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03826953</url>
  </required_header>
  <id_info>
    <org_study_id>AC17008</org_study_id>
    <nct_id>NCT03826953</nct_id>
  </id_info>
  <brief_title>Allergy UK Research and Development Nurse Project</brief_title>
  <acronym>ALLUKN</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergy UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the research project is to develop, deliver and assess the feasibility of a&#xD;
      nurse-led allergy clinic in primary care, taking into account population, geographical area&#xD;
      and needs of healthcare in the area chosen. It is widely acknowledged that the majority of&#xD;
      cases of mild to moderate allergy could be adequately dealt with in primary care, by a&#xD;
      healthcare professional with the appropriate expertise and knowledge of allergy. The&#xD;
      provision of allergy care in the community could potentially have a beneficial impact on&#xD;
      health care and patient outcomes.&#xD;
&#xD;
      The project will comprise the set up and delivery of a nurse led allergy clinic in primary&#xD;
      care and use a mix of qualitative and quantitative methods to evaluate the feasibility of the&#xD;
      clinic. This will include the use of a series of validated questionnaires e.g. satisfaction,&#xD;
      condition specific quality of life and economic cost questionnaires, as well as face to face&#xD;
      interviews.&#xD;
&#xD;
      The research will collect data to see if this clinical intervention is feasible and allow&#xD;
      audit of the clinical intervention. This will also enable the researchers to understand&#xD;
      patients lived experiences of accessing allergy care and the effect of allergy on quality of&#xD;
      life and impact of allergy care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will consist of the development and delivery of a nurse led clinical intervention&#xD;
      to provide allergy care in the community within the NHS Lothian primary care setting. The&#xD;
      clinical intervention will see the allergy nurse provide clinical care to patients with a&#xD;
      specified range of allergic conditions and provide diagnosis and immediate management where&#xD;
      appropriate.&#xD;
&#xD;
      The clinical component of the research project will consist of a pilot nurse led allergy&#xD;
      clinic, provided by one specialist nurse twice a week across two different GP surgeries&#xD;
      within NHS Lothian, GPs from across 12 practices will be encouraged to refer into the pilot&#xD;
      allergy clinic.&#xD;
&#xD;
      The referring health care professional will advise participants and their carers that the&#xD;
      nurse led allergy clinic has been set up as part of a research project and participants will&#xD;
      be asked if they wish to consent to take part in the research study. Feedback on the pilot&#xD;
      clinic will be gathered to find out if the pilot clinic is acceptable to participants&#xD;
      (satisfaction questionnaire), to find out if the clinic has made any improvement to quality&#xD;
      of life (condition specific quality of life questionnaire) and if there is any cost impact&#xD;
      (cost questionnaire).&#xD;
&#xD;
      Participants The initial consultation - explanation of research project and written informed&#xD;
      consent obtained.&#xD;
&#xD;
      The nurse practitioner will:&#xD;
&#xD;
        -  Take a thorough allergy clinical history including examination of the participant as&#xD;
           necessary and identify what clinical care is required,&#xD;
&#xD;
        -  Carry out any investigations that are required eg Skin prick testing to common food and&#xD;
           aeroallergens.&#xD;
&#xD;
        -  Give advice both written and verbal to support the management of allergies, including&#xD;
           demonstration of medical devices e.g. adrenaline auto injectors, inhalers etc.&#xD;
&#xD;
        -  Prescribe any necessary medication&#xD;
&#xD;
        -  Provide a written summary of the consultation and any prescribed medication.&#xD;
&#xD;
      Participants will complete a series of three questionnaires, satisfaction, condition specific&#xD;
      quality of life and cost questionnaires.&#xD;
&#xD;
      Follow up appointments where deemed appropriate will be conducted by telephone using a&#xD;
      specified protocol. Where this is not appropriate face to face reviews will be arranged&#xD;
      during clinic time. While short term follow-ups will be provided, there are no facilities to&#xD;
      offer long term follow up for participants attending the allergy clinic under this pilot and&#xD;
      all participants will return to their health care professional for follow up and long term&#xD;
      management. If the participant has complex allergies or requires specialist intervention the&#xD;
      participant will be advised that they will require referral into secondary care.&#xD;
&#xD;
      As part of the research project an email support service will be set up to support the health&#xD;
      care professionals involved in the project.&#xD;
&#xD;
      The study will utilize a combination of qualitative and quantitative methods to evaluate the&#xD;
      clinical intervention at baseline and at six weeks to determine the feasibility of the clinic&#xD;
      and patient outcomes with this clinical intervention.&#xD;
&#xD;
      The tools available to the researcher include a series of validated surveys including patient&#xD;
      and clinician satisfaction surveys, condition specific quality of life and economic cost to&#xD;
      patient.&#xD;
&#xD;
      Interviews In addition face to face interviews will be offered to a subset of participants to&#xD;
      enable further understanding of their perspective and experiences of the nurse-led allergy&#xD;
      clinic. This will be to see if this intervention is feasible and improves patient care.&#xD;
&#xD;
      The views of health care professionals and practice managers referring into this clinic will&#xD;
      also be sought using a satisfaction questionnaire and qualitative interviews at 12 weeks&#xD;
      after the start of the clinic and 10-12 months from the end of the project.&#xD;
&#xD;
      Data on allergy will be requested from GP practices and NHS Information services Division&#xD;
      (ISD) for quantitative analysis at baseline and at the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 4, 2017</start_date>
  <completion_date type="Anticipated">January 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire,in patients</measure>
    <time_frame>3 year feasibility study</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To find out if a nurse-led clinic in primary care is feasible measured using a validated satisfaction questionnaire in primary care</measure>
    <time_frame>3 year feasibility study</time_frame>
    <description>The questionnaire will measure health care professionals experience of referring patients into the clinic using the satisfaction questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To find out if a nurse-led clinic in primary care is feasible measured using a validated health economics survey</measure>
    <time_frame>3 year feasibility study</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To find out if a nurse-led clinic in primary care is feasible measured using qualitative interviews</measure>
    <time_frame>3 year feasibility study</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure quality of life in patients using validated disease specific quality of life questionnaires Infants Dermatology Quality of Life Index IDQOL</measure>
    <time_frame>3 Years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure quality of life in patients validated disease specific quality of life questionnaires Mini Rhinitis Quality of Life Questionnaire (mini RQLQ)</measure>
    <time_frame>3 Years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Adult Form - (FAQLQ - AF)</measure>
    <time_frame>3 Years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality of Life Questionnaire - Teenagers Form (FAQLQ - TF)</measure>
    <time_frame>3 Years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure quality of life in patients validated disease specific quality of life questionnaires Food Allergy Quality Of Life Questionnaire - Parents Form (FAQLQ - PF)</measure>
    <time_frame>3 Years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Allergy</condition>
  <arm_group>
    <arm_group_label>Nurse led allergy clinic</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>nurse led allergy clinic</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nurse Led Allergy Clinic</intervention_name>
    <description>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.</description>
    <arm_group_label>Nurse led allergy clinic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All children, young people and adults who fit the selection criteria from across all the&#xD;
        practices can be referred to the allergy clinic.&#xD;
&#xD;
        All patients and parents / carers where appropriate must be deemed capable of giving&#xD;
        informed consent to take part in the research project.&#xD;
&#xD;
          -  Infants under two with suspected food allergy&#xD;
&#xD;
          -  Infants under two with moderate-to-severe eczema not responding to standard treatment.&#xD;
&#xD;
          -  Children and young people (up to 16 years of age) with suspected allergic rhinitis&#xD;
             symptoms that are unresponsive to a combination of oral antihistamines and nasal&#xD;
             steroids&#xD;
&#xD;
          -  Young people and adults (from 16 years of age) with a history of anaphylaxis or&#xD;
             suspected anaphylaxis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Over 2 years of age with delayed type food allergy presenting primarily with&#xD;
             gastrointestinal symptoms&#xD;
&#xD;
          -  Over 2 years of age with confirmed non IgE-mediated symptoms including food&#xD;
             intolerances, coeliac disease etc.&#xD;
&#xD;
          -  Single urticarial reactions without an obvious triggers&#xD;
&#xD;
          -  Non-allergic chronic urticaria&#xD;
&#xD;
          -  Drug allergy&#xD;
&#xD;
          -  Well controlled allergic rhinitis, asthma or atopic eczema&#xD;
&#xD;
          -  Mild-to-moderate atopic eczema without an obvious allergic trigger&#xD;
&#xD;
          -  Localised insect sting reactions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aziz Sheikh</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Edinburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Prof Schwarze</last_name>
    <phone>+44 0131 536 0800</phone>
    <email>Jurgen.Schwarze@ed.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Margaret Kelman</last_name>
    <phone>+44 0131 650 3469</phone>
    <email>m.kelman@ed.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Of Edinburgh Health Centre</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH8 9AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean Grant</last_name>
      <phone>0131 650 2777</phone>
      <email>jean.grant@nhslothian.scot.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>19797601</PMID>
  </reference>
  <reference>
    <citation>Ben-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.</citation>
    <PMID>25926095</PMID>
  </reference>
  <reference>
    <citation>Cummings 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.</citation>
    <PMID>20180792</PMID>
  </reference>
  <reference>
    <citation>Dhami 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.</citation>
    <PMID>25567768</PMID>
  </reference>
  <reference>
    <citation>Gupta 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.</citation>
    <PMID>15080802</PMID>
  </reference>
  <reference>
    <citation>Jutel 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.</citation>
    <PMID>24117436</PMID>
  </reference>
  <reference>
    <citation>Levy 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.</citation>
    <PMID>19588053</PMID>
  </reference>
  <reference>
    <citation>MacKenzie 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.</citation>
    <PMID>19702674</PMID>
  </reference>
  <reference>
    <citation>Pereira 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.</citation>
    <PMID>16210065</PMID>
  </reference>
  <reference>
    <citation>Punekar 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.</citation>
    <PMID>19400899</PMID>
  </reference>
  <reference>
    <citation>Tejedor-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.</citation>
    <PMID>26182682</PMID>
  </reference>
  <reference>
    <citation>Scadding 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.</citation>
    <PMID>18081563</PMID>
  </reference>
  <reference>
    <citation>Smith 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.</citation>
    <PMID>26807213</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>May 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nurse led allergy clinic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03826953
org study id: AC17008
nct id: NCT03826953
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention 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.
primary purpose: Health Services Research
masking: None (Open Label)
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
description: 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
measure: 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
description: The questionnaire will measure health care professionals experience of referring patients into the clinic using the satisfaction questionnaire
measure: 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
description: 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.
measure: To find out if a nurse-led clinic in primary care is feasible measured using qualitative interviews
time frame: 3 year feasibility study
description: 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.
measure: 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
description: 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
measure: 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
description: 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
measure: 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
description: 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
measure: 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
description: 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
measure: 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
description: 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
arm group label: Nurse led allergy clinic
arm group type: Other
description: nurse led allergy clinic
intervention type: Other
intervention name: Nurse Led Allergy Clinic
description: 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.
arm group label: Nurse led allergy clinic
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aziz Sheikh
role: Principal Investigator
affiliation: University of Edinburgh
last name: Prof Schwarze
phone: +44 0131 536 0800
email: Jurgen.Schwarze@ed.ac.uk
last name: Margaret Kelman
phone: +44 0131 650 3469
email: m.kelman@ed.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
citation: 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.
PMID: 19797601
citation: Ben-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.
PMID: 25926095
citation: Cummings 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.
PMID: 20180792
citation: Dhami 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.
PMID: 25567768
citation: Gupta 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.
PMID: 15080802
citation: Jutel 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.
PMID: 24117436
citation: Levy 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.
PMID: 19588053
citation: MacKenzie 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.
PMID: 19702674
citation: Pereira 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.
PMID: 16210065
citation: Punekar 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.
PMID: 19400899
citation: Tejedor-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.
PMID: 26182682
citation: Scadding 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.
PMID: 18081563
citation: Smith 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.
PMID: 26807213
responsible party type: Sponsor
mesh term: Hypersensitivity
sharing ipd: No