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

Adan Medical Innovation

Status: Completed

Conditions: Anaphylaxis

Treatments: Behavioral: Device: Anapphylaxis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02854969

AnapphylaxisQoL

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

epinephrine auto-injector

No Intervention group

Description:

3 months using the epinephrine auto-injector alone, and after that 3 more months using the epinephrine auto-injector + medical device

epinephrine auto-injector + medical device

Experimental group

Description:

Device: Anapphylaxis is a medical device with a case for an epinephrine autoinjector that connects via Bluetooth to a mobile application 3 months using the epinephrine auto-injector + medical device , and after that 3 more months using the epinephrine auto-injector alone

Treatment:

Behavioral: Device: Anapphylaxis