Impact of E-learning on Parental Confidence in Managing Food Allergy

October 13, 2021 updated by: Ieva Adomaite, Vilnius University
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Food allergy is a common childhood morbidity, that has increased in prevalence over the last few decades. Education and dietary support is integral in managing food allergy in children; however it is labor intensive and requires financial resources, which places an economic burden on the healthcare system. The study aim is analyze the impact of E-learning on parental confidence in managing their child's food allergy.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania
        • Vilnius University Hospital Santaros Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participant non proficient in Lithuanian.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E-learning
Participants (parents of food-allergic children) will use an E-learning platform on food allergies for one month.
Behavioral: E-learning
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.
No Intervention: Standard care
Participants (parents of food-allergic children) will receive standard allergist consulting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental confidence in managing food allergy
Time Frame: After 1 month.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental satisfaction
Time Frame: After 1 month.
Parental satisfaction will be assessed using Visual Analog Satisfaction Scale. Minimum score - 0, maximum score - 100. Higher score represents higher satisfaction.
After 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University

Investigators

  • Principal Investigator: Ieva Adomaite, Vilnius University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

July 3, 2021

First Submitted That Met QC Criteria

July 3, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18BMTV33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data, following deidentification will be available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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