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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05404165

Collaborator

(none)

Enrollment

3.3

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Anaphylactic Reaction, Self-administration, Adrenaline, Self-assessment

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

56 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Anticipated Study Start Date :

May 23, 2022

Anticipated Primary Completion Date :

Aug 15, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

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 [One day]
A two-part, 20-point self-assessment scale: A visual analog scale addressing skills in identifying situations requiring administration of self-injectable epinephrine, scored out of 10 points A visual analogue scale for technical skills in administering epinephrine by self-injecting pen, scored out of 10 points A two-part health professional assessment scale scored out of 20 points: A single response questionnaire asked to the patient including 5 standardized clinical situations, validated by an expert committee, requiring or not the administration of Adrenalin, scored out of 10 points An evaluation of the technical skills of injecting adrenaline with a self-injecting pen with a demonstration pen, in 6 steps, scored out of 10 points

Secondary Outcome Measures

Correlation between patient self-assessment and healthcare professional assessment of ability to identify situations requiring administration of self-injectable epinephrine [One day]
A 10-point self-assessment scale in the form of a visual analogue scale on the ability to identify situations requiring the administration of self-injectable epinephrine and a hetero-assessment with a 10-point single-answer questionnaire including 5 standardized clinical situations, validated by an expert committee, requiring or not the administration of adrenaline
Correlation between a patient's self-assessment and a healthcare professional's assessment of technical skills in performing epinephrine administration by self-injecting pen [One day]
A 10-point self-assessment scale in the form of a visual analog scale of technical skills in performing epinephrine administration by self-injecting pen and a 10-point hetero-assessment of epinephrine injection skills by self-injecting pen with a 6-step demonstration pen.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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