Educating adolescents at Risk of Anaphylaxis

ISRCTN	ISRCTN06898570
DOI	https://doi.org/10.1186/ISRCTN06898570
Secondary identifying numbers	13139

Submission date: 17/10/2012
Registration date: 18/10/2012
Last edited: 26/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Neil Davidson
Scientific

Newcastle upon Tyne Hospitals NHS Foundation Trust
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Email	neil.davidson@nuth.nhs.uk

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Educating adolescents at Risk of Anaphylaxis
Study acronym	ERA
Study objectives	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(s)	First MREC, 10 January 2012 ref: 11/EE/0530
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	05/11/2012
Completion date	07/06/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	11 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	UK Sample Size: 80; Description: 40 in intervention group 40 controls
Key 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
Key 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
Date of first enrolment	05/11/2012
Date of final enrolment	07/06/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

New Victoria Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

Website	http://www.newcastle-hospitals.org.uk/
"ROR"	https://ror.org/05p40t847

Funders

Funder type

Industry

ALK - Abello LTD (UK)

No information available

Allergy Therapeutics (UK)

No information available

Meda AB (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

26/04/2016: No publications found, verifying study status with principal investigator