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Relevance of the Self-assessment of Skills for Self-administration of Adrenaline by Auto-injectors in Patients at Risk of Severe Anaphylactic Reaction (PacAdré)

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Unknown

Conditions

Severe Anaphylactic Reaction, Self-administration, Adrenaline, Self-assessment

Study type

Observational

Funder types

Other

Identifiers

NCT05404165
38RC22.0156

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

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Central trial contact

Alexis BOCQUET, Md

Data sourced from clinicaltrials.gov

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