Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/06/2011
Date assigned
16/08/2011
Last edited
12/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.ucc.ie/en/

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

Publication citations

Additional files

Editorial Notes

12/04/2017: Plain English summary added.