24 hour parental access to expert anaphylaxis management advice
| ISRCTN | ISRCTN29793562 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29793562 |
- Submission date
- 20/06/2011
- Registration date
- 16/08/2011
- Last edited
- 12/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Anaphylaxis is a severe and potentially life-threatening reaction to a trigger such as an allergy. Outside of hospital, food allergies are the most important triggers of anaphylaxis in children. People with potentially serious allergies are often given an adrenaline auto-injector to carry at all times, which can help stop an anaphylactic reaction becoming life threatening. However, many families struggle to comply with instructions and there is often a delay or a failure to administer adrenaline in cases that have sadly ended with a fatal outcome. Parents of children with food allergies report uncertainty in relation to “what is going to happen next time”, which contributes to anxiety and low quality of life. This is because families are generally on their own and remote from medical help when they need to make the decision about whether or not to use the adrenaline auto-injector. They may be uncertain if the reaction is severe enough to warrant using the autoinjector or they may be worried that their child may come to harm if given adrenaline when the reaction was not severe. Most clinical services encourage families to treat early: if in doubt give the adrenaline, as delay can worsen the outcome. However, this is a difficult decision for parents to make, even in a life-threatening scenario. The aim of this study is to find out whether 24 hour availability of expert advice from a Paediatric Allergy team via telephone improves the quality of life of families living with food allergy.
Who can participate?
Parents of patients aged up to 16 attending the Paediatric Allergy Clinic in Cork University Hospital (CUH), prescribed and trained in the use of adrenaline auto-injectors for serious food allergy
What does the study involve?
Participating families are randomly allocated to receive 24 hour access to expert support or to receive routine care. At the start of study and after 1 month and 6 months (end of study) all families complete a quality of life questionnaire. The number of A&E/hospital attendances, use of adrenaline auto-injector in an emergency, and inappropriate calls to the helpline are also assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University College Cork (Ireland)
When is the study starting and how long is it expected to run for?
September 2011 to May 2012
Who is funding the study?
University College Cork (Ireland)
Who is the main contact?
Prof. Jonathan Hourihane
J.Hourihane@ucc.ie
Contact information
Scientific
Paediatrics and Child Health
University College Cork
Clinical investigations Unit
Cork University Hospital
Wilton
Cork
N/A
Ireland
| Phone | +353 (0)21 490 1237 |
|---|---|
| J.Hourihane@ucc.ie |
Study information
| Study design | Prospective blinded pragmatic effectiveness trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | 24 hour parental access to expert anaphylaxis management advice: a prospective, blinded, pragmatic effectiveness trial |
| Study objectives | 24 hour access to expert advice via telephone will improve quality of life for families living with food allergy. |
| Ethics approval(s) | Clinical Research Ethics Committee Cork Teaching Hospitals, UCC, 30/05/2011, ref: ECM3 07/06/11 |
| Health condition(s) or problem(s) studied | Anaphylaxis, food allergy |
| Intervention | Provision of 24 hour telephone access to expert allergy clinic staff to assist in family decision to use or not use adrenline autoinjectors in the setting of an unanticipated allergic reaction. 50 families will be randomised to I (Intervention) or R (Routine) care. Intervention group will receive a telephone number that will be open 24/7 for 6 months, giving access to expert advice in the case of an allergic reaction. Routine arm will not be given this number. Food Allergy Quality of Life (FAQL) will be measured before randomisation and at 1 month and 6 months post randomisation. |
| Intervention type | Other |
| Primary outcome measure | The difference/relative change in quality of life between Intervention and Routine care arms, on an intention-to-treat basis at 6 months |
| Secondary outcome measures | 1. Difference in Food Allergy Quality of Life (FAQL) at 1 month post randomisation 2. Incident reports (number of accident & emergency [A&E]/hospital attendances, use of adrenaline auto-injector in an emergency, inappropriate calls to the helpline) |
| Overall study start date | 01/09/2011 |
| Completion date | 31/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Parents of newly referred and exisiting patients (up to 16 years) attending Paediatric Allergy Clinic in Cork University Hospital (CUH) 2. Families trained by CUH clinc staff and demonstrating competence in use of adrenaline autoinjectors to treat anaphylaxis |
| Key exclusion criteria | Familes who do not complete satisfactory CUH training in use of adrenaline autoinjectors to treat anaphylaxis |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- Ireland
Study participating centre
N/A
Ireland
Sponsor information
University/education
Western Road Cork
Cork
N/A
Ireland
| Phone | +353 (0)21 490 3000 |
|---|---|
| crec@ucc.ie | |
| Website | http://www.ucc.ie/en/ |
"ROR" |
https://ror.org/03265fv13 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Coláiste na hOllscoile Corcaigh, UCC
- Location
- Ireland
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 |
Editorial Notes
12/04/2017: Plain English summary added.
