Educating adolescents at Risk of Anaphylaxis
| ISRCTN | ISRCTN06898570 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06898570 |
| Protocol serial number | 13139 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Funders | ALK - Abello LTD (UK), Allergy Therapeutics (UK), Meda AB (UK) |
- 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
Scientific
Newcastle upon Tyne Hospitals NHS Foundation Trust
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
| neil.davidson@nuth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Knowledge & skills measured at study entry, at end of education session and at follow-up (3 months after session) |
| Key secondary outcome measure(s) |
1. Carriage of SIA device, measured at study entry and follow-up (3 months) |
| Completion date | 07/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 80 |
| 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
- United Kingdom
- England
Study participating centre
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne
NE1 4LP
United Kingdom
NE1 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/04/2016: No publications found, verifying study status with principal investigator
