Health LiteracyNCT04475003
Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis
An observational study of Health Literacy and Anaphylaxis, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial summary
Research on health literacy among caregivers of children with IgE-mediated allergy at risk of anaphylaxis (life-threatening allergic reaction). Health literacy is a person's ability to understand health information so that they can maintain or improve their health and quality of life (of themself and children). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Anaphylaxis
- What is being tested?
- Teaching
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Sep 2020to 30 Apr 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: For each child that is known with IgE-mediated allergy with risk of anaphylaxis parents can invitate 4 Caregivers of children with IgE-mediated allergy with risk of anaphylaxis (adults, grandparents, school caregivers etc.).
Who may be able to join
- caregivers of children with IgE-mediated allergy with risk of anaphylaxis (adults, grandparents, school caregivers etc.).
- minimum 18 years old.
- signed informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Algemeen Ziekenhuis Maria Middelares
Ghent, Oost-Vlaanderen, 9000
Jasmine S Leus, +329 246 8200, jasmine.leus@azmmsj.be
Josefien L Vandekerckhove, +329 246 8200, josefien.vandekerckhove@gmail.com
About this study
Research on health literacy among caregivers of children with IgE-mediated allergy at risk of anaphylaxis (life-threatening allergic reaction). Health literacy is a person's ability to understand health information so that they can maintain or improve their health and quality of life (of themself and children).
The aim of the study is to test the general knowledge of anaphylaxis. Furthermore we test the extent to which caregivers consider themselves able to recognize and to treat anaphylaxis.
- Conditions
- Health Literacy, Anaphylaxis
- Being tested
- Teaching
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeachingOther
Teaching session about anaphylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
General knowledge of anaphylaxis.
Knowledge Quiz
Measured: 1.5 year
Secondary outcomes (1)
The extent to which caregivers consider themselves able to recognize and to treat anaphylaxis.
Numeric scoring scale (0= cannot do at all, 5= highly certain can do)
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start30 Sep 2020 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Jasmine Leus, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Jasmine S Leus, Principal investigator, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475003
- Sponsor's protocol ID
- MMS2020.017
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis
- ClinicalTrials.gov ID
- NCT04475003
- Acronym / sponsor ID
- MMS2020.017
- Conditions
- Health Literacy, Anaphylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 17 Jul 2020 (actual)
- 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.
Research on health literacy among caregivers of children with IgE-mediated allergy at risk of anaphylaxis (life-threatening allergic reaction). Health literacy is a person's ability to understand health information so that they can maintain or improve their health and quality of life (of themself and children).
The aim of the study is to test the general knowledge of anaphylaxis. Furthermore we test the extent to which caregivers consider themselves able to recognize and to treat anaphylaxis.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For each child that is known with IgE-mediated allergy with risk of anaphylaxis parents can invitate 4 Caregivers of children with IgE-mediated allergy with risk of anaphylaxis (adults, grandparents, school caregivers etc.).
Key inclusion criteria (3 listed)
- caregivers of children with IgE-mediated allergy with risk of anaphylaxis (adults, grandparents, school caregivers etc.).
- minimum 18 years old.
- signed informed consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| TeachingTeaching session about anaphylaxis | Other | – |
Primary outcome
General knowledge of anaphylaxis.
Time frame: 1.5 year
Knowledge Quiz
1 secondary outcome
The extent to which caregivers consider themselves able to recognize and to treat anaphylaxis.
Time frame: 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Jasmine S Leus principal investigator
Algemeen Ziekenhuis Maria Middelares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Literacy and Anaphylaxis, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jul 2020. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasmine S Leus (+329 246 8200, jasmine.leus@azmmsj.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General knowledge of anaphylaxis. (time frame: 1.5 year). 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 17 Jul 2020.