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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44075

Enrollment

Registered

2016-03-15

Start date

2015-03-14

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anaphylaxis food-allergy

Interventions

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

anaphylaxis

epinephrine auto-injector

food-allergy

quality of life

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - Food-allergic children and adolescents (aged 8-17 years) being suspected of a food allergy requiring an epinephrine auto-injector - Above mentioned patients undergoing a routine double blind, placebo-controlled food challenge in our food challenge unit. - Never self-administered an epinephrine auto-injector. - Informed consent obtained from parent / guardian or participant, as appropriate.

Exclusion criteria

Exclusion criteria: Food-allergic children 17 years.

Design outcomes

Primary

Measure	Time frame
The main study parameter is to test the feasibility of methods and procedures prior to performance of a full-scale research project.	—

Secondary

Measure	Time frame
The secondary study parameters of this study the possible difference (improvement or deteroriation) between HRQL, the measured burden of treatment of an EAI, perceived disease severity and anxiety and confidence with an EAI on both measuring time points (baseline and follow-up) between (a) children (aged 8-12 years) and their parents who did self-administer an EAI and (b) children (aged 8-12 years) and their parents who did not selfadminister an EAI (age group 1). And also, between (c) teenagers (aged 13-17 years) and their parents who did self-administer and EAI and (d) teenagers (aged 13-17 years) and their parents who did not self-administer an EAI (age group 2). A difference in total FAQLQ scores of >=0.5 points will be considered to be a clinically relevant difference (=minimal important difference (MID)). The difference in total FAQLQ score between both measuring points (baseline and follow-up) will be compared with the GRCscore, to identify which increase or decrease in FAQLQ score corresponded to the score of minimal important change on the GRC(34,35). If there is a significant improvement in HRQL, this will be used for calculating a number needed to treat (NNT) of prescribing an EAI to food allergic patients.	—

Measure

Time frame

The secondary study parameters of this study the possible difference (improvement or deteroriation) between HRQL, the measured burden of treatment of an EAI, perceived disease severity and anxiety and confidence with an EAI on both measuring time points (baseline and follow-up) between (a) children (aged 8-12 years) and their parents who did self-administer an EAI and (b) children (aged 8-12 years) and their parents who did not selfadminister an EAI (age group 1). And also, between (c) teenagers (aged 13-17 years) and their parents who did self-administer and EAI and (d) teenagers (aged 13-17 years) and their parents who did not self-administer an EAI (age group 2). A difference in total FAQLQ scores of >=0.5 points will be considered to be a clinically relevant difference (=minimal important difference (MID)). The difference in total FAQLQ score between both measuring points (baseline and follow-up) will be compared with the GRCscore, to identify which increase or decrease in FAQLQ score corresponded to the score of minimal important change on the GRC(34,35). If there is a significant improvement in HRQL, this will be used for calculating a number needed to treat (NNT) of prescribing an EAI to food allergic patients.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)