AnaphylaxisNCT02854969
Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device
A study testing Device: Anapphylaxis in people with Anaphylaxis, run by Adan Medical Innovation, SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaphylaxis
- What is being tested?
- Device: Anapphylaxis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to 18 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Anaphylaxis
- Being tested
- Device: Anapphylaxis
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: AnapphylaxisBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Device: Anapphylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction through a questionnaire in the use of the medical device
Measured: 3 months
Secondary outcomes (2)
Medical device safety
Adverse events related to the medical device
Measured: 3 months
Patient Adherence to the medical device through a questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startMay 2016
- Primary completion18 Jul 2017
- Study completion18 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adan Medical Innovation, SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854969
- Sponsor's protocol ID
- AnapphylaxisQoL
- Status last verified
- Aug 2016
- First submitted
- 22 Jul 2016
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02854969
- Acronym / sponsor ID
- AnapphylaxisQoL
- Conditions
- Anaphylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Adan Medical Innovation, SLIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 18 Jul 2017 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Device: AnapphylaxisDevice: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who have not signed the informed consent
- Patients with some limitations for understanding or following correctly the trial procedures
- Pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Anapphylaxis | Behavioural | epinephrine auto-injector + medical device |
Primary outcome
Patient satisfaction through a questionnaire in the use of the medical device
Time frame: 3 months
2 secondary outcomes
Medical device safety
Time frame: 3 months
Patient Adherence to the medical device through a questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Anapphylaxis in people with Anaphylaxis, run by Adan Medical Innovation, SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction through a questionnaire in the use of the medical device (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.