Condition category
Injury, Occupational Diseases, Poisoning
Date applied
17/10/2012
Date assigned
18/10/2012
Last edited
26/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.newcastle-hospitals.org.uk/

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

Publication citations

Additional files

Editorial Notes

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