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 Marys 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
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