An investigation of the usability of different adrenaline autoinjector devices
| ISRCTN | ISRCTN29175528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29175528 |
| Secondary identifying numbers | version 13.0 27th January 2012 |
- Submission date
- 08/03/2012
- Registration date
- 14/03/2012
- Last edited
- 24/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Imperial College London
Department of Paediatrics
Wright Fleming Building
Norfolk Place
London
W2 1PG
United Kingdom
| r.boyle@nhs.net |
Study information
| Study design | Randomised controlled single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An investigation of the usability of different adrenaline autoinjector devices |
| Study objectives | 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(s) | West London Research Ethics Committee, 01/03/2012, ref: 0/H0711/76 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 14/03/2012 |
| Completion date | 31/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key exclusion criteria | Previous training to use one of the alternative adrenaline autoinjector devices used in this study |
| Date of first enrolment | 14/03/2012 |
| Date of final enrolment | 31/08/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W2 1PG
United Kingdom
Sponsor information
University/education
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
| lucy.parker@imperial.ac.uk | |
| Website | http://www3.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Industry
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2015 | Yes | No |
Editorial Notes
24/02/2016: Publication reference added.
