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Digital technology for anaphylaxis management impact on patient behaviour: A randomized clinical trial
Author(s) -
SalaCunill Anna,
Luengo Olga,
Curran Adrian,
Moreno Nuria,
LabradorHorrillo Moises,
Guilarte Mar,
GonzalezMedina Mónica,
GalvanBlasco Paula,
Cardona Victoria
Publication year - 2021
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/all.14626
Subject(s) - medicine , anaphylaxis , randomized controlled trial , clinical endpoint , epinephrine , visual analogue scale , crossover study , anxiety , clinical trial , patient satisfaction , allergy , anesthesia , surgery , immunology , alternative medicine , pathology , placebo , psychiatry
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 < .0001). The adherence VAS improved from 59.7 (95% CI, 54.0‐65.3) to 88.6 (95% CI, 84.2‐92.9) ( P < .0001). Overall, 90% patients found the medical device easy to use. Patients’ anxiety decreased from 52.2% to 29.3% ( P < .001). Seven episodes of anaphylaxis occurred during the study, all in patients without the medical device ( P = .025). Eighty‐eight per cent of patients felt more involved in the management of anaphylaxis when using the medical device. Conclusion This is the first clinical trial evaluating digital technology for EAIs, showing a change of behaviour in patients at risk of anaphylaxis, increasing satisfaction, improving adherence, and reducing anxiety, with good usability.