Clinical trial NCT05404165: Relevance of the Self-assessment of Skills for Self-administration of Adrenaline by Auto-injectors in Patients at Risk of Severe Anaphylactic Reaction (PacAdré)
Official title: Relevance of the Self-assessment of Skills for Self-administration of Adrenaline by Auto-injectors in Patients at Risk of Severe Anaphylactic Reaction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Anaphylactic Reaction, Self-administration, Adrenaline, Self-assessment
Keywords: Adrenaline
Self-administration
Self-assessment
Severe anaphylactic reaction
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are being monitored for severe allergy or systemic mastocytosis and who need to have adrenaline treatment with them in case of anaphylaxis.

Brief summary: To investigate the correlation between self-assessment by patients and an assessment by a health professional of the skills needed for self administration of adrenaline by auto-injectors. These skills include the identification of situations requiring the administration of adrenaline and the technical abilities to achieve it.

Hypothesis:

A self-assessment correlated with an external assessment would make it easier to adjust the frequency of therapeutic education sessions based on the patient's self-assessment alone.

Detailed description: Intramuscular Adrenaline is the standard treatment for severe to moderate anaphylaxis. Self-administration of Adrenaline by the patient using an auto-injector pen in case of anaphylaxis is a major axis of management of patients with severe food allergy, hymenoptera venom allergy or systemic mastocytosis. This self-administration skill requires prior therapeutic education of the patient. This education must be repeated over time and must include two components: the identification of anaphylactic situations requiring the self-administration of Adrenalin and the technical skills and abilities to carry out this self-injection.

Numerous studies have investigated the technical skills for using Adrenaline auto-injector pens according to the device prescribed, the importance of therapeutic education, the optimal frequency of therapeutic education sessions for self-administration and the main barriers to the use of Adrenaline.

To our knowledge, no study has investigated the correlation between patients' self-assessment of the skills required for self-administration of Adrenaline by self-injecting pen and an external assessment of these same skills by a health professional.

A self-assessment correlated with an external assessment would make it easier to adjust the frequency of therapeutic education sessions based on patient self-assessment alone.

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Follow-up at the CHU Grenoble Alpes or at the CH Métropole Savoie with at least one consultation every 2 years
* With a pathology at risk of severe anaphylaxis:

  * Severe food allergy and/or,
  * Allergy to wasp venom and/or
  * Systemic mastocytosis
* With a current adrenaline prescription that is more than a year old

Exclusion Criteria:

* Patient with a pathology at risk of severe anaphylaxis not identified in the inclusion criteria (isolated drug allergy, idiopathic anaphylaxis, etc.)
* Patient with cognitive or memory disorders
* Patient not speaking French or with a limited understanding of the language
* Patient not affiliated to a social security scheme
* Refusal of the patient to participate in the research or inability of the patient to give his consent
* Patient under guardianship or subject deprived of liberty

Primary outcomes:
measure: Correlation between a patient self-assessment and a health care professional's assessment of the skills needed to self-administer epinephrine by self-injecting pen
timeFrame: One day
Secondary outcomes:
measure: Correlation between patient self-assessment and healthcare professional assessment of ability to identify situations requiring administration of self-injectable epinephrine
timeFrame: One day
measure: Correlation between a patient's self-assessment and a healthcare professional's assessment of technical skills in performing epinephrine administration by self-injecting pen
timeFrame: One day
Other outcomes:
Locations:
Study officials:
affiliation: CHU Grenoble Alpes
name: Alexis BOCQUET, Md
role: PRINCIPAL_INVESTIGATOR
References:
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