Food Allergy in ChildrenNCT04955132
Impact of E-learning on Parental Confidence in Managing Food Allergy
A study testing E-learning in people with Food Allergy in Children and Food Allergy in Infants, run by Vilnius University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Allergy in Children, Food Allergy in Infants
- What is being tested?
- E-learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jul 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participant non proficient in Lithuanian.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Food Allergy in Children, Food Allergy in Infants
- Being tested
- E-learning
- Keywords
- Food allergy, Milk, Egg, Wheat, Children
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-learningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| E-learning | Experimental | Participants (parents of food-allergic children) will use an E-learning platform on food allergies for one month. Receives: Behavioral: E-learning |
| Standard care | No intervention | Participants (parents of food-allergic children) will receive standard allergist consulting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 1 month.
Secondary outcomes (1)
Parental satisfaction
Parental satisfaction will be assessed using Visual Analog Satisfaction Scale. Minimum score - 0, maximum score - 100. Higher score represents higher satisfaction.
Measured: After 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ieva Adomaite, Vilnius University
- Investigators
- Ieva Adomaite, Principal investigator, Vilnius University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955132
- Sponsor's protocol ID
- 18BMTV33
- Status last verified
- Oct 2021
- First submitted
- 3 Jul 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data, following deidentification will be available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of E-learning on Parental Confidence in Managing Food Allergy
- ClinicalTrials.gov ID
- NCT04955132
- Acronym / sponsor ID
- 18BMTV33
- Conditions
- Food Allergy in Children, Food Allergy in Infants
- Keywords
- Food allergy, Milk, Egg, Wheat, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-learning | Experimental | Behavioral: E-learningParticipants (parents of food-allergic children) will use an E-learning platform on food allergies for one month. |
| Standard care | No intervention | –Participants (parents of food-allergic children) will receive standard allergist consulting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participant non proficient in Lithuanian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-learningThe 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. | Behavioural | E-learning |
Primary outcome
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.
1 secondary outcome
Parental satisfaction
Time frame: After 1 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: Yes. All collected data, following deidentification will be available.
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Slow Multiallergen Oral Immunotherapy in Young Children
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ieva Adomaite principal investigator
Vilnius University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-learning in people with Food Allergy in Children and Food Allergy in Infants, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental confidence in managing food allergy (time frame: After 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.