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UnknownNCT05404165

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
56 (estimated)
Sponsor
University Hospital, Grenoble · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2022-05-23
Primary completion
2022-08-15
Completion
2022-09-01
First posted
2022-06-03
Last updated
2022-06-03

Source: ClinicalTrials.gov record NCT05404165. Inclusion in this directory is not an endorsement.