NCT04955132

Brief Summary

Education and dietary support are integral in managing food allergy in children. The study aim is to analyze the impact of E-learning on parental confidence in managing their child's food allergy.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 1, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

July 3, 2021

Last Update Submit

October 13, 2021

Conditions

Keywords

Food allergyMilkEggWheatChildren

Outcome Measures

Primary Outcomes (1)

  • Parental confidence in managing food allergy

    Parental confidence will be assessed using Food Allergy Self-Efficacy Scale for Parents (FASE-P). Single item minimum score - 0, maximum score - 100. Higher scores represent higher parental confidence.

    After 1 month.

Secondary Outcomes (1)

  • Parental satisfaction

    After 1 month.

Study Arms (2)

E-learning

EXPERIMENTAL

Participants (parents of food-allergic children) will use an E-learning platform on food allergies for one month.

Behavioral: E-learning

Standard care

NO INTERVENTION

Participants (parents of food-allergic children) will receive standard allergist consulting.

Interventions

E-learningBEHAVIORAL

The participants in the experimental arm will be able to use a food allergy e-learning tool, that provides comprehensive knowledge of the most common food allergies (milk, egg and wheat), their management and dietary guidelines.

E-learning

Eligibility Criteria

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

You may qualify if:

  • Legal caregivers of a child that is allergic (confirmed by an allergist) to at least one of the main food allergens (cow's milk, egg or wheat) and is following an elimination diet to at least one of these allergens.
  • Internet access available.

You may not qualify if:

  • Participant non proficient in Lithuanian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University Hospital Santaros Clinics

Vilnius, Lithuania

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ieva Adomaite

    Vilnius University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2021

First Posted

July 8, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

All collected data, following deidentification will be available.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations