NCT02854969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2017

Completed
Last Updated

July 26, 2017

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

July 22, 2016

Last Update Submit

July 25, 2017

Conditions

Anaphylaxis

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (2)

  • Medical device safety

    3 months

  • Patient Adherence to the medical device through a questionnaire

    3 months

Study Arms (2)

epinephrine auto-injector

NO INTERVENTION

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

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

Interventions

Device: AnapphylaxisBEHAVIORAL
epinephrine auto-injector + medical device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 4, 2016

Study Start

May 1, 2016

Primary Completion

July 18, 2017

Study Completion

July 18, 2017

Last Updated

July 26, 2017

Record last verified: 2016-08

Locations

ES(1)