Plain English Summary
Background and study aims
Anaphylaxis is a severe and potentially life-threatening reaction to a trigger such as an allergy. Outside of hospital, food allergies are the most important triggers of anaphylaxis in children. People with potentially serious allergies are often given an adrenaline auto-injector to carry at all times, which can help stop an anaphylactic reaction becoming life threatening. However, many families struggle to comply with instructions and there is often a delay or a failure to administer adrenaline in cases that have sadly ended with a fatal outcome. Parents of children with food allergies report uncertainty in relation to “what is going to happen next time”, which contributes to anxiety and low quality of life. This is because families are generally on their own and remote from medical help when they need to make the decision about whether or not to use the adrenaline auto-injector. They may be uncertain if the reaction is severe enough to warrant using the autoinjector or they may be worried that their child may come to harm if given adrenaline when the reaction was not severe. Most clinical services encourage families to treat early: if in doubt give the adrenaline, as delay can worsen the outcome. However, this is a difficult decision for parents to make, even in a life-threatening scenario. The aim of this study is to find out whether 24 hour availability of expert advice from a Paediatric Allergy team via telephone improves the quality of life of families living with food allergy.
Who can participate?
Parents of patients aged up to 16 attending the Paediatric Allergy Clinic in Cork University Hospital (CUH), prescribed and trained in the use of adrenaline auto-injectors for serious food allergy
What does the study involve?
Participating families are randomly allocated to receive 24 hour access to expert support or to receive routine care. At the start of study and after 1 month and 6 months (end of study) all families complete a quality of life questionnaire. The number of A&E/hospital attendances, use of adrenaline auto-injector in an emergency, and inappropriate calls to the helpline are also assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University College Cork (Ireland)
When is the study starting and how long is it expected to run for?
September 2011 to May 2012
Who is funding the study?
University College Cork (Ireland)
Who is the main contact?
Prof. Jonathan Hourihane
J.Hourihane@ucc.ie
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jonathan Hourihane
ORCID ID
Contact details
Paediatrics and Child Health
University College Cork
Clinical investigations Unit
Cork University Hospital
Wilton
Cork
N/A
Ireland
+353 (0)21 490 1237
J.Hourihane@ucc.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
-
Study information
Scientific title
24 hour parental access to expert anaphylaxis management advice: a prospective, blinded, pragmatic effectiveness trial
Acronym
Study hypothesis
24 hour access to expert advice via telephone will improve quality of life for families living with food allergy.
Ethics approval
Clinical Research Ethics Committee Cork Teaching Hospitals, UCC, 30/05/2011, ref: ECM3 07/06/11
Study design
Prospective blinded pragmatic effectiveness trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Anaphylaxis, food allergy
Intervention
Provision of 24 hour telephone access to expert allergy clinic staff to assist in family decision to use or not use adrenline autoinjectors in the setting of an unanticipated allergic reaction.
50 families will be randomised to I (Intervention) or R (Routine) care. Intervention group will receive a telephone number that will be open 24/7 for 6 months, giving access to expert advice in the case of an allergic reaction. Routine arm will not be given this number. Food Allergy Quality of Life (FAQL) will be measured before randomisation and at 1 month and 6 months post randomisation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The difference/relative change in quality of life between Intervention and Routine care arms, on an intention-to-treat basis at 6 months
Secondary outcome measures
1. Difference in Food Allergy Quality of Life (FAQL) at 1 month post randomisation
2. Incident reports (number of accident & emergency [A&E]/hospital attendances, use of adrenaline auto-injector in an emergency, inappropriate calls to the helpline)
Overall trial start date
01/09/2011
Overall trial end date
31/05/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Parents of newly referred and exisiting patients (up to 16 years) attending Paediatric Allergy Clinic in Cork University Hospital (CUH)
2. Families trained by CUH clinc staff and demonstrating competence in use of adrenaline autoinjectors to treat anaphylaxis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Familes who do not complete satisfactory CUH training in use of adrenaline autoinjectors to treat anaphylaxis
Recruitment start date
01/09/2011
Recruitment end date
31/05/2012
Locations
Countries of recruitment
Ireland
Trial participating centre
University College Cork
Cork
N/A
Ireland
Sponsor information
Organisation
University College Cork (Ireland)
Sponsor details
Western Road Cork
Cork
N/A
Ireland
+353 (0)21 490 3000
crec@ucc.ie
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University College Cork
Alternative name(s)
Coláiste na hOllscoile Corcaigh, UCC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Ireland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary