Health Literacy Among Caregivers of Children With IgE-med... | NCT04475003

Studies
Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis

NCT04475003

Sponsor

Algemeen Ziekenhuis Maria Middelares

Status

Unknown status

Last Update Posted

Jul 17, 2020Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Health Literacy
Anaphylaxis

Interventions

Teaching

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2020Estimated

Primary Completion Date

Apr 30, 2022Estimated

Completion Date

Apr 30, 2022Estimated

First Submitted Date

Jul 14, 2020

First Submission Date that Met QC Criteria

Jul 16, 2020

First Posted Date

Jul 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2020

Last Update Posted Date

Jul 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

dr. Jasmine Leus, Kinderarts, Algemeen Ziekenhuis Maria MiddelaresPrincipal Investigator

Lead Sponsor

Algemeen Ziekenhuis Maria MiddelaresOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
Teaching	Other	Teaching session about anaphylaxis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
General knowledge of anaphylaxis.	Knowledge Quiz	1.5 year

Secondary Outcomes

Measure	Description	Time Frame
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)	1.5 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jasmine S Leus	Contact	+329 246 8200		jasmine.leus@azmmsj.be
Josefien L Vandekerckhove	Contact	+329 246 8200		josefien.vandekerckhove@gmail.com

Overall Officials

Name	Affiliation	Role
Jasmine S Leus	Algemeen Ziekenhuis Maria Middelares	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algemeen Ziekenhuis Maria Middelares		Ghent	Oost-Vlaanderen	9000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000707	Anaphylaxis

Ancestor Terms

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004522	Educational Status

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided