NCT04475003

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 30, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

July 14, 2020

Last Update Submit

July 16, 2020

Conditions

Health LiteracyAnaphylaxis

Outcome Measures

Primary Outcomes (1)

  • General knowledge of anaphylaxis.

    Knowledge Quiz

    1.5 year

Secondary Outcomes (1)

  • The extent to which caregivers consider themselves able to recognize and to treat anaphylaxis.

    1.5 year

Interventions

TeachingOTHER

Teaching session about anaphylaxis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.).

You may qualify if:

  • caregivers of children with IgE-mediated allergy with risk of anaphylaxis (adults, grandparents, school caregivers etc.).
  • minimum 18 years old.
  • signed informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algemeen Ziekenhuis Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Anaphylaxis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Jasmine S Leus

    Algemeen Ziekenhuis Maria Middelares

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmine S Leus

CONTACT

+329 246 8200jasmine.leus@azmmsj.be

Josefien L Vandekerckhove

CONTACT

+329 246 8200josefien.vandekerckhove@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kinderarts

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 17, 2020

Study Start

September 30, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

July 17, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)