Condition category
Injury, Occupational Diseases, Poisoning
Date applied
08/03/2012
Date assigned
14/03/2012
Last edited
24/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Adrenaline autoinjectors are prescribed for patients at risk of severe systemic allergic reactions (anaphylaxis), most commonly for children with food allergy. Several different devices are available, and patients are sometimes switched from their own device to a new one. It is unclear whether switching a patient from one device to a new one without training them in the new device means that they will be less able to effectively administer adrenaline in the event of anaphylaxis. This study is designed to answer whether 'device switches' without training in how to use the new device are potentially harmful, by decreasing patients' ability to effectively administer adrenaline for treatment of anaphylaxis.

Who can participate:
Participants from the MAMA research study (ISRCTN12504076) who have completed the study.

What does the study involve?
Assessment of whether participants are able to effectively administer adrenaline, using one of several different adrenaline autoinjector devices.

What are the possible benefits and risks of participating?
The benefits are possibly to understand more about severe allergic reactions and their management. The risk is that participation may be slightly stressful, since the scenario-based assessment of adrenaline autoinjector use is quite realistic.

Where is the study run from?
St Mary’s Hospital, Paddington and Imperial College London (UK)

When is the study starting and how long is it expected to run for?
March 2012 to August 2013

Who is funding the study?
Lincoln Medical, a company that makes adrenaline autoinjectors

Who is the main contact?
Dr Robert Boyle
r.boyle@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Boyle

ORCID ID

Contact details

Imperial College London
Department of Paediatrics
Wright Fleming Building
Norfolk Place
London
W2 1PG
United Kingdom
-
r.boyle@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

version 13.0 27th January 2012

Study information

Scientific title

An investigation of the usability of different adrenaline autoinjector devices

Acronym

Study hypothesis

In mothers of children with food allergy who were trained to use a specific adrenaline autoinjector device a year ago, the rate of successful adrenaline administration will be lower when using an alternative autoinjector device, than the success rate when using their own device.

Ethics approval

West London Research Ethics Committee, 01/03/2012, ref: 0/H0711/76

Study design

Randomised controlled single-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Food allergy

Intervention

Randomised controlled assessment - subjects will be randomly allocated to have 1 of 4 different types of training assessment, but will not receive any active intervention apart from the assessment.

Participants are randomly allocated to be assessed using 1 of 4 different adrenaline autoinjector devices, which they have not previously been trained to use.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measures

Ability to effectively administer adrenaline using a trainer autoinjector device in a simulated anaphylaxis scenario, assessed by a trained observer.

Secondary outcome measures

Adverse events during simulated anaphylaxis scenario, assessed by a trained observer.

Overall trial start date

14/03/2012

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Completion of primary and secondary outcome assessments in MAMA trial (http://www.controlled-trials.com/ISRCTN12504076/)
2. Willingness to participate in a further assessment

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

Previous training to use one of the alternative adrenaline autoinjector devices used in this study

Recruitment start date

14/03/2012

Recruitment end date

31/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

South Kensington Campus
London
SW7 2AZ
United Kingdom
-
lucy.parker@imperial.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Industry

Funder name

Lincoln Medical Ltd (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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25850463

Publication citations

Additional files

Editorial Notes

24/02/2016: Publication reference added.