Training food-allergic patients to use their epinephrine auto-injector: a pilot study

Currently, the only treatment for food allergy is avoidance of the culprit food
and the provision of an epinephrine auto-injector (EAI) in emergency
situations(1). Living with the need to avoid the culprit foods, living in fear
of allergic reactions and having to carry an epinephrine
auto-injector at all times may interfere with daily life of food-allergic
children and adolescents, and their families. Consequently, an accurate
diagnosis is very important in order to identify which foods should be avoided,
followed by proper patient education.
Previous studies repeatedly stress that there is a need for better education of
food-allergic patients and their parents concerning instructions about when and
how to the use of EAI. Using self-administration of an EAI (when needed) as a
didactic tool (training program) may
be more effective in alleviating fear and uncertainty incurred by the prospect
of using the device. This may, in turn, lead to improved HRQL. It is therefore
of interest to ascertain whether EAI self-administration does indeed have these
effects.

Primary Objective:
The primary objective of this study is to test the feasibility of methods and
procedures prior to performance of a full-scale research project.

Secondary Objective(s):
The secondary objectives of this study are to determine whether HRQL, burden of
treatment (BoT) of an EAI, anxiousness and confidence using an EAI of
food-allergic patients improves by undergoing a training program including
administering an EAI to themselves (or being
administered by a parent) during a routine DFPCFC resulting in an allergic
reaction. A difference in total FAQLQ scores of >=0.5 points will be considered
to be a clinically relevant difference (=minimal important difference (MID)).

This pilot study is a prospective randomized pilot study, with an estimated
inclusion time of six months (February 1st, 2015 until July 31st, 2015).

Self-administration of an EAI during a DBPCFC resulting a objective allergic
symptoms.

Patients meeting all inclusion criteria without meeting any exclusion criteria
will be eligible for randomization. Patients who visit our FCU and who enter
the study potentially benefit from the self-administration of an EAI during a
routine DBPCFC resulting in objective
allergic symptoms. The routine DBPCFC takes place on two different days,
therefore they will visit the hospital on two occasions.
After self-administration of an EAI (when needed) the patient may feel more
confident and empowered to use their own EAI if needed and without hesitation.
This may, in turn, lead to improved HRQL. Transient pharmacologic effects of
epinephrine, such
as pallor, tremor, anxiety, palpitations, headache, and dizziness, that occur
within 5 to10 minutes after injection are usually mild and confirm that a
therapeutic epinephrine dose has been given.
Serious adverse effects are rare with intramuscular use, and are usually
attributable to epinephrine overdose, which is unlikely to happen
when using an auto-injector with a single fixed dose of epinephrine.

The burden of the online questionnaire-packages is low, the time requested is
less than 15 minutes. Patients are asked to complete twice an online
questionnaire-pakcage; the total time requested is 30 minutes. The burden will
be minimal due to extensive
experience in our FCU with DBPCFCs. Nevertheless, we are aware, that the
outcome of the DBPCFC is unpredictable and reactions may occur in patients.

The study can only be done in this group of children (aged <18 years) because
we find high numbers of sensitization and atopy in children. Also, adolescents
in particular are the age-group with the highest risk for food allergy
fatalities.