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Allergy UK Research and Development Nurse Project (ALLUKN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826953
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Allergy UK
Information provided by (Responsible Party):
University of Edinburgh

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Allergy Other: Nurse Led Allergy Clinic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : July 4, 2017
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Nurse led allergy clinic
nurse led allergy clinic
Other: Nurse Led Allergy Clinic
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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

  3. 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 ]
    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

  4. 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 ]
    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

  5. 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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826953


Contacts
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Contact: Prof Schwarze +44 0131 536 0800 Jurgen.Schwarze@ed.ac.uk
Contact: Margaret Kelman +44 0131 650 3469 m.kelman@ed.ac.uk

Locations
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United Kingdom
University Of Edinburgh Health Centre Recruiting
Edinburgh, United Kingdom, EH8 9AL
Contact: Jean Grant    0131 650 2777    jean.grant@nhslothian.scot.nhs.uk   
Sponsors and Collaborators
University of Edinburgh
Allergy UK
Investigators
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Principal Investigator: Aziz Sheikh University of Edinburgh
Additional Information:
Publications:

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03826953    
Other Study ID Numbers: AC17008
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
nurse led allergy clinic
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases