Contact information
Type
Scientific
Primary contact
Dr Neil Davidson
ORCID ID
Contact details
Newcastle upon Tyne Hospitals NHS Foundation Trust
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
-
neil.davidson@nuth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13139
Study information
Scientific title
Educating adolescents at Risk of Anaphylaxis
Acronym
ERA
Study hypothesis
Anaphylaxis describes a serious and possibly life-threatening allergic reaction. Food allergy accounts for 85% of reactions in children and risk factors for severity include age (adolescents & young adults) and delayed use of rescue medication adrenaline (epinephrine). In this study, we believe that a teaching programme that is relevant to teenagers, and takes account of their fears and anxieties about the condition, will increase their knowledge, understanding and treatment of allergic symptoms, and in so doing also improve their perceptions of quality of life issues associated with anaphylaxis risk. We aim to invite 80 young people, aged 11-16 years, with confirmed food (nut) allergy and who are prescribed a self-injectable adrenaline autoinjector (SIA) to participate in the study. These patients attend the regional allergy clinic at the Great North Children's Hospital, Royal Victoria Infirmary, Newcastle.
We will compare how the standard clinic education session (control) differs to a novel education package (intervention) in improving patient knowledge, understanding, skill in using autoinjector and quality of life scores. The intervention will involve facilitated discussion, review of videos of simulated anaphylactic reactions and their management, as well as hands-on practice using different SIA devices. Those patients attending the teaching intervention and who have a smartphone will be offered an app that directly supports the session learning points, including prompts to carry and renew medication and guidance to treatment of an anaphylactic reaction. Knowledge, understanding and treatment skills will be assessed by a quiz and demonstration of correct use of SIA device. Quality of life perceptions will be assessed by a questionnaire. Participant views about the teaching intervention will be collected by session evaluation questionnaires and semi-structured interview.
Ethics approval
First MREC, 10 January 2012 ref: 11/EE/0530
Study design
Randomised interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anaphylactic shock in paediatrics
Intervention
Education Session:
A face-to-face teaching session involving discussion groups; video demonstration of (simulated) anaphylactic reactions and management; demonstration and practice with adrenaline SIAs; knowledge & skill assessments.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Knowledge & skills measured at study entry, at end of education session and at follow-up (3 months after session)
Secondary outcome measures
1. Carriage of SIA device, measured at study entry and follow-up (3 months)
2. Impact of smartphone app measured at follow-up - self-reported and correlated with knowledge / skills / QoL.
3. Quality of life measured at study entry and at follow-up (3 months)
Overall trial start date
05/11/2012
Overall trial end date
07/06/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Be a young person aged 11-16 years (inclusive)
2. Be a patient of the Great North Children's Hospital regional allergy clinic
3. Have confirmed food (nut) allergy
4. Have been prescribed an adrenaline self-injectable autoinjector device
5. Speak and understand written and spoken English
6. Male or female participants
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
UK Sample Size: 80; Description: 40 in intervention group 40 controls
Participant exclusion criteria
1. Must not have another (non-allergic/ atopic) chronic medical condition
2. Regarded by parent/carer as not yet capable of supported, independent allergy care
3. Unable to speak and/or understand written and spoken English
Recruitment start date
05/11/2012
Recruitment end date
07/06/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
New Victoria Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
ALK - Abello LTD (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Allergy Therapeutics (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Meda AB (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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