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

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ClinicalTrials.gov Identifier: NCT02854969
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Adan Medical Innovation, SL

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.

Condition or disease Intervention/treatment Phase
Anaphylaxis Behavioral: Device: Anapphylaxis Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized, Cross-over, Open, Unicentric Trial Evaluating Satisfaction With the Use of a Medical Device for the Epinephrine Auto-injector in Patients With Anaphylaxis
Study Start Date : May 2016
Actual Primary Completion Date : July 18, 2017
Actual Study Completion Date : July 18, 2017


Arm Intervention/treatment
No Intervention: epinephrine auto-injector
3 months using the epinephrine auto-injector alone, and after that 3 more months using the epinephrine auto-injector + medical device
Experimental: epinephrine auto-injector + medical device

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

Behavioral: Device: Anapphylaxis



Primary Outcome Measures :
  1. Patient satisfaction through a questionnaire in the use of the medical device [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Medical device safety [ Time Frame: 3 months ]
    Adverse events related to the medical device

  2. Patient Adherence to the medical device through a questionnaire [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854969


Locations
Spain
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Adan Medical Innovation, SL

Responsible Party: Adan Medical Innovation, SL
ClinicalTrials.gov Identifier: NCT02854969     History of Changes
Other Study ID Numbers: AnapphylaxisQoL
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents