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

Primary Purpose

Anaphylaxis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Device: Anapphylaxis
Sponsored by
Adan Medical Innovation, SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anaphylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

epinephrine auto-injector

epinephrine auto-injector + medical device

Arm Description

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

Outcomes

Primary Outcome Measures

Patient satisfaction through a questionnaire in the use of the medical device

Secondary Outcome Measures

Medical device safety
Adverse events related to the medical device
Patient Adherence to the medical device through a questionnaire

Full Information

First Posted
July 22, 2016
Last Updated
July 25, 2017
Sponsor
Adan Medical Innovation, SL
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1. Study Identification

Unique Protocol Identification Number
NCT02854969
Brief Title
Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 18, 2017 (Actual)
Study Completion Date
July 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adan Medical Innovation, SL

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaphylaxis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epinephrine auto-injector
Arm Type
No Intervention
Arm Description
3 months using the epinephrine auto-injector alone, and after that 3 more months using the epinephrine auto-injector + medical device
Arm Title
epinephrine auto-injector + medical device
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Device: Anapphylaxis
Primary Outcome Measure Information:
Title
Patient satisfaction through a questionnaire in the use of the medical device
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Medical device safety
Description
Adverse events related to the medical device
Time Frame
3 months
Title
Patient Adherence to the medical device through a questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

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

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