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

May 30, 2022 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between patient self-assessment and healthcare professional assessment of ability to identify situations requiring administration of self-injectable epinephrine
Time Frame: 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
One day
Correlation between a patient's self-assessment and a healthcare professional's assessment of technical skills in performing epinephrine administration by self-injecting pen
Time Frame: 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.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Alexis BOCQUET, Md, Chu Grenoble Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 23, 2022

Primary Completion (Anticipated)

August 15, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

May 30, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC22.0156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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