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

July 25, 2017 updated by: Adan Medical Innovation, SL

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction through a questionnaire in the use of the medical device
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical device safety
Time Frame: 3 months
Adverse events related to the medical device
3 months
Patient Adherence to the medical device through a questionnaire
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adan Medical Innovation, SL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

July 18, 2017

Study Completion (Actual)

July 18, 2017

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnapphylaxisQoL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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