Severe Anaphylactic Reaction, Self-administration, Adrenaline, Self-assessmentPacAdréNCT05404165
Relevance of the Self-assessment of Skills for Self-administration of Adrenaline by Auto-injectors in Patients at Risk of Severe Anaphylactic Reaction (PacAdré)
An observational study of Severe Anaphylactic Reaction, Self-administration, Adrenaline, Self-assessment, run by University Hospital, Grenoble.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Anaphylactic Reaction, Self-administration, Adrenaline, Self-assessment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 23 May 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Keywords
- Adrenaline, Self-administration, Self-assessment, Severe anaphylactic reaction
- Medical subject headings
- Anaphylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: One day
Secondary outcomes (2)
Correlation between patient self-assessment and healthcare professional assessment of ability to identify situations requiring administration of self-injectable epinephrine
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
Measured: 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
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start23 May 2022 (estimated)
- Primary completion15 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Severe Anaphylactic Reaction, Self-administration, Adrenaline, Self-assessmentStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis BOCQUET, Md, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404165
- Sponsor's protocol ID
- 38RC22.0156
- Acronym
- PacAdré
- Status last verified
- May 2022
- First submitted
- 30 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bilo MB, Cichocka-Jarosz E, Pumphrey R, Oude-Elberink JN, Lange J, Jakob T, Bonadonna P, Fernandez J, Kosnik M, Helbling A, Mosbech H, Gawlik R, Niedoszytko M, Patella V, Pravettoni V, Rodrigues-Alves R, Sturm GJ, Rueff F. Self-medication of anaphylactic reactions due to Hymenoptera stings-an EAACI Task Force Consensus Statement. Allergy. 2016 Jul;71(7):931-43. doi: 10.1111/all.12908. Epub 2016 Apr 29.
PubMed 27060567Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Beyer K, Bindslev-Jensen C, Cardona V, Dubois A, duToit G, Eigenmann P, Fernandez Rivas M, Halken S, Hickstein L, Host A, Knol E, Lack G, Marchisotto MJ, Niggemann B, Nwaru BI, Papadopoulos NG, Poulsen LK, Santos AF, Skypala I, Schoepfer A, Van Ree R, Venter C, Worm M, Vlieg-Boerstra B, Panesar S, de Silva D, Soares-Weiser K, Sheikh A, Ballmer-Weber BK, Nilsson C, de Jong NW, Akdis CA; EAACI Food Allergy and Anaphylaxis Guidelines Group. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014 Aug;69(8):1008-25. doi: 10.1111/all.12429. Epub 2014 Jun 9.
PubMed 24909706Broesby-Olsen S, Dybedal I, Gulen T, Kristensen TK, Moller MB, Ackermann L, Saaf M, Karlsson MA, Agertoft L, Brixen K, Hermann P, Stylianou E, Mortz CG, Torfing T, Havelund T, Sander B, Bergstrom A, Bendix M, Garvey LH, Bjerrum OW, Valent P, Bindslev-Jensen C, Nilsson G, Vestergaard H, Hagglund H. Multidisciplinary Management of Mastocytosis: Nordic Expert Group Consensus. Acta Derm Venereol. 2016 Jun 15;96(5):602-12. doi: 10.2340/00015555-2325.
PubMed 26694951Sirin Kose S, Asilsoy S, Tezcan D, Al S, Atay O, Kangalli O, Uzuner N, Karaman O. Is There an Optimal Training Interval to Improve the Correct Use of Adrenaline Auto-Injectors? Int Arch Allergy Immunol. 2020;181(2):136-140. doi: 10.1159/000504365. Epub 2019 Dec 3.
PubMed 31794965Topal E, Bakirtas A, Yilmaz O, Ertoy IH, Arga M, Demirsoy MS, Turktas I. A real-life study on acquired skills from using an adrenaline autoinjector. Int Arch Allergy Immunol. 2013;160(3):301-6. doi: 10.1159/000341367. Epub 2012 Oct 18.
PubMed 23095342Ridolo E, Montagni M, Bonzano L, Savi E, Peveri S, Costantino MT, Crivellaro M, Manzotti G, Lombardi C, Caminati M, Incorvaia C, Senna G. How far from correct is the use of adrenaline auto-injectors? A survey in Italian patients. Intern Emerg Med. 2015 Dec;10(8):937-41. doi: 10.1007/s11739-015-1255-z. Epub 2015 May 20.
PubMed 25990486Segal N, Garty BZ, Hoffer V, Levy Y. Effect of instruction on the ability to use a self-administered epinephrine injector. Isr Med Assoc J. 2012 Jan;14(1):14-7.
PubMed 22624436Shemesh E, D'Urso C, Knight C, Rubes M, Picerno KM, Posillico AM, Atal Z, Annunziato RA, Sicherer SH. Food-Allergic Adolescents at Risk for Anaphylaxis: A Randomized Controlled Study of Supervised Injection to Improve Comfort with Epinephrine Self-Injection. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):391-397.e4. doi: 10.1016/j.jaip.2016.12.016. Epub 2017 Jan 20.
PubMed 28117270Song TT, Worm M, Lieberman P. Anaphylaxis treatment: current barriers to adrenaline auto-injector use. Allergy. 2014 Aug;69(8):983-91. doi: 10.1111/all.12387. Epub 2014 May 16.
PubMed 24835773Simons FE, Ardusso LR, Bilo MB, El-Gamal YM, Ledford DK, Ring J, Sanchez-Borges M, Senna GE, Sheikh A, Thong BY; World Allergy Organization. World Allergy Organization anaphylaxis guidelines: summary. J Allergy Clin Immunol. 2011 Mar;127(3):587-93.e1-22. doi: 10.1016/j.jaci.2011.01.038. No abstract available.
PubMed 21377030Yu JE, Lin RY. The Epidemiology of Anaphylaxis. Clin Rev Allergy Immunol. 2018 Jun;54(3):366-374. doi: 10.1007/s12016-015-8503-x.
PubMed 26357949Pumphrey RS. Lessons for management of anaphylaxis from a study of fatal reactions. Clin Exp Allergy. 2000 Aug;30(8):1144-50. doi: 10.1046/j.1365-2222.2000.00864.x.
PubMed 10931122
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05404165
- Acronym / sponsor ID
- PacAdré / 38RC22.0156
- Keywords
- Adrenaline, Self-administration, Self-assessment, Severe anaphylactic reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 23 May 2022 (estimated)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
- With a current adrenaline prescription that is more than a year old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Correlation between patient self-assessment and healthcare professional assessment of ability to identify situations requiring administration of self-injectable epinephrine
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Background: PubMed 27060567Bilo MB, Cichocka-Jarosz E, Pumphrey R, Oude-Elberink JN, Lange J, Jakob T, Bonadonna P, Fernandez J, Kosnik M, Helbling A, Mosbech H, Gawlik R, Niedoszytko M, Patella V, Pravettoni V, Rodrigues-Alves R, Sturm GJ, Rueff F. Self-medication of anaphylactic reactions due to Hymenoptera stings-an EAACI Task Force Consensus Statement. Allergy. 2016 Jul;71(7):931-43. doi: 10.1111/all.12908. Epub 2016 Apr 29.
- Background: PubMed 24909706Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Beyer K, Bindslev-Jensen C, Cardona V, Dubois A, duToit G, Eigenmann P, Fernandez Rivas M, Halken S, Hickstein L, Host A, Knol E, Lack G, Marchisotto MJ, Niggemann B, Nwaru BI, Papadopoulos NG, Poulsen LK, Santos AF, Skypala I, Schoepfer A, Van Ree R, Venter C, Worm M, Vlieg-Boerstra B, Panesar S, de Silva D, Soares-Weiser K, Sheikh A, Ballmer-Weber BK, Nilsson C, de Jong NW, Akdis CA; EAACI Food Allergy and Anaphylaxis Guidelines Group. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014 Aug;69(8):1008-25. doi: 10.1111/all.12429. Epub 2014 Jun 9.
- Background: PubMed 26694951Broesby-Olsen S, Dybedal I, Gulen T, Kristensen TK, Moller MB, Ackermann L, Saaf M, Karlsson MA, Agertoft L, Brixen K, Hermann P, Stylianou E, Mortz CG, Torfing T, Havelund T, Sander B, Bergstrom A, Bendix M, Garvey LH, Bjerrum OW, Valent P, Bindslev-Jensen C, Nilsson G, Vestergaard H, Hagglund H. Multidisciplinary Management of Mastocytosis: Nordic Expert Group Consensus. Acta Derm Venereol. 2016 Jun 15;96(5):602-12. doi: 10.2340/00015555-2325.
- Background: PubMed 31794965Sirin Kose S, Asilsoy S, Tezcan D, Al S, Atay O, Kangalli O, Uzuner N, Karaman O. Is There an Optimal Training Interval to Improve the Correct Use of Adrenaline Auto-Injectors? Int Arch Allergy Immunol. 2020;181(2):136-140. doi: 10.1159/000504365. Epub 2019 Dec 3.
- Background: PubMed 23095342Topal E, Bakirtas A, Yilmaz O, Ertoy IH, Arga M, Demirsoy MS, Turktas I. A real-life study on acquired skills from using an adrenaline autoinjector. Int Arch Allergy Immunol. 2013;160(3):301-6. doi: 10.1159/000341367. Epub 2012 Oct 18.
- Background: PubMed 25990486Ridolo E, Montagni M, Bonzano L, Savi E, Peveri S, Costantino MT, Crivellaro M, Manzotti G, Lombardi C, Caminati M, Incorvaia C, Senna G. How far from correct is the use of adrenaline auto-injectors? A survey in Italian patients. Intern Emerg Med. 2015 Dec;10(8):937-41. doi: 10.1007/s11739-015-1255-z. Epub 2015 May 20.
- Background: PubMed 22624436Segal N, Garty BZ, Hoffer V, Levy Y. Effect of instruction on the ability to use a self-administered epinephrine injector. Isr Med Assoc J. 2012 Jan;14(1):14-7.
- Background: PubMed 28117270Shemesh E, D'Urso C, Knight C, Rubes M, Picerno KM, Posillico AM, Atal Z, Annunziato RA, Sicherer SH. Food-Allergic Adolescents at Risk for Anaphylaxis: A Randomized Controlled Study of Supervised Injection to Improve Comfort with Epinephrine Self-Injection. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):391-397.e4. doi: 10.1016/j.jaip.2016.12.016. Epub 2017 Jan 20.
- Background: PubMed 24835773Song TT, Worm M, Lieberman P. Anaphylaxis treatment: current barriers to adrenaline auto-injector use. Allergy. 2014 Aug;69(8):983-91. doi: 10.1111/all.12387. Epub 2014 May 16.
- Background: PubMed 21377030Simons FE, Ardusso LR, Bilo MB, El-Gamal YM, Ledford DK, Ring J, Sanchez-Borges M, Senna GE, Sheikh A, Thong BY; World Allergy Organization. World Allergy Organization anaphylaxis guidelines: summary. J Allergy Clin Immunol. 2011 Mar;127(3):587-93.e1-22. doi: 10.1016/j.jaci.2011.01.038. No abstract available.
- Background: PubMed 26357949Yu JE, Lin RY. The Epidemiology of Anaphylaxis. Clin Rev Allergy Immunol. 2018 Jun;54(3):366-374. doi: 10.1007/s12016-015-8503-x.
- Background: PubMed 10931122Pumphrey RS. Lessons for management of anaphylaxis from a study of fatal reactions. Clin Exp Allergy. 2000 Aug;30(8):1144-50. doi: 10.1046/j.1365-2222.2000.00864.x.
- Prise en charge de l'anaphylaxie en médecine d'urgence.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis BOCQUET, Md principal investigator
CHU Grenoble Alpes
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Anaphylactic Reaction, Self-administration, Adrenaline, Self-assessment, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexis BOCQUET, Md (+33 4 76 76 58 19, abocquet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404165, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.