Back to resultsImpact of E-learning on Parental Confidence in Managing Food Allergy
Primary Purpose
Food Allergy in Children, Food Allergy in Infants
Status
Unknown status
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
E-learning
Sponsored by
About this trial
This is an interventional health services research trial for Food Allergy in Children focused on measuring Food allergy, Milk, Egg, Wheat, Children
Eligibility Criteria
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.
Sites / Locations
- Vilnius University Hospital Santaros Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
E-learning
Standard care
Arm Description
Participants (parents of food-allergic children) will use an E-learning platform on food allergies for one month.
Participants (parents of food-allergic children) will receive standard allergist consulting.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Parental satisfaction
Parental satisfaction will be assessed using Visual Analog Satisfaction Scale. Minimum score - 0, maximum score - 100. Higher score represents higher satisfaction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04955132
Brief Title
Impact of E-learning on Parental Confidence in Managing Food Allergy
Official Title
Impact of E-learning on Parental Confidence in Managing Food Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vilnius University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy in Children, Food Allergy in Infants
Keywords
Food allergy, Milk, Egg, Wheat, Children
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
E-learning
Arm Type
Experimental
Arm Description
Participants (parents of food-allergic children) will use an E-learning platform on food allergies for one month.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Participants (parents of food-allergic children) will receive standard allergist consulting.
Intervention Type
Behavioral
Intervention Name(s)
E-learning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parental confidence in managing food allergy
Description
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.
Time Frame
After 1 month.
Secondary Outcome Measure Information:
Title
Parental satisfaction
Description
Parental satisfaction will be assessed using Visual Analog Satisfaction Scale. Minimum score - 0, maximum score - 100. Higher score represents higher satisfaction.
Time Frame
After 1 month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ieva Adomaite
Organizational Affiliation
Vilnius University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vilnius University Hospital Santaros Clinics
City
Vilnius
Country
Lithuania
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data, following deidentification will be available.
Learn more about this trial
Impact of E-learning on Parental Confidence in Managing Food Allergy
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