Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device

Randomized, Cross-over, Open, Unicentric Trial Evaluating Satisfaction With the Use of a Medical Device for the Epinephrine Auto-injector in Patients With Anaphylaxis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02854969

Enrollment

100

Registered

2016-08-04

Start date

2016-05-31

Completion date

2017-07-18

Last updated

2017-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaphylaxis

Brief summary

Through several questionaries the investigators will measure the satisfaction of patients diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a smart case for an epinephrine autoinjector connected via Bluetooth to a mobile application.

Interventions

BEHAVIORALDevice: Anapphylaxis

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients 18 years old or above * Patients diagnosed with Anaphylaxis and an epinephrine auto-injector prescribed * Patients with a smartphone * Patients who signed the informed consent

Exclusion criteria

* Patients who have not signed the informed consent * Patients with some limitations for understanding or following correctly the trial procedures * Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame
Patient satisfaction through a questionnaire in the use of the medical device	3 months

Secondary

Measure	Time frame	Description
Medical device safety	3 months	Adverse events related to the medical device
Patient Adherence to the medical device through a questionnaire	3 months	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026