Digital technology for anaphylaxis management impact on patient behaviour: A randomized clinical trial
Autor: | Victoria Cardona, Anna Sala-Cunill, Moises Labrador-Horrillo, Adrian Curran, Nuria Moreno, Mónica Gonzalez-Medina, Olga Luengo, Paula Galvan-Blasco, Mar Guilarte |
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Rok vydání: | 2020 |
Předmět: |
Adult
Male 0301 basic medicine medicine.medical_specialty Epinephrine Visual analogue scale Immunology Injections law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Autoinjector law Internal medicine medicine Clinical endpoint Humans Immunology and Allergy Epinephrine autoinjector Anaphylaxis Digital Technology Cross-Over Studies business.industry medicine.disease Clinical trial 030104 developmental biology 030228 respiratory system Anxiety Female medicine.symptom business |
Zdroj: | Allergy. 76:1507-1516 |
ISSN: | 1398-9995 0105-4538 |
Popis: | BACKGROUND Epinephrine is the first-line treatment for anaphylaxis. Patients at risk should always carry an epinephrine autoinjector (EAI). Several EAI gaps have been identified. We sought to evaluate satisfaction using a medical device (digital technology comprising an EAI smart case connected to a mobile APP) with functions that overcome most of the EAI limitations and to determine whether patient behaviour and anaphylaxis management improve with its use. METHODS This was a randomized, open-label, crossover clinical trial in a tertiary hospital involving patients with history of anaphylaxis carrying an EAI. The study was conducted in two three-month periods, one with and one without the medical device. The primary endpoint was satisfaction with the medical device. Usability, adherence, anxiety and anaphylaxis episodes were evaluated as secondary endpoints. RESULTS A total of 100 patients were included (mean age 38.1 years, 74% female), and 95 completed the trial. The satisfaction visual analogue scale (VAS) after using the medical device was higher than before its use (89.1 [95% CI, 60.2-99.1] vs 56.3 [95% CI, 48.1-81.4]; P |
Databáze: | OpenAIRE |
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