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The Quality of Life of Mothers of Children With IgE-mediated Food Allergy

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ClinicalTrials.gov Identifier: NCT04740632
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Study Description
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Brief Summary:
Food allergy (FA) derives from an abnormal immunological response to dietary antigens. On the basis of the immunological mechanism, FA are divided into the following forms: IgE-mediated, non-IgE-mediated and mixed. Prevalence, persistence and severity of pediatric FA have significantly increased over the past 2 decades. The treatment of FA is based on a rigorous elimination diet and on the correct management of acute allergic reactions, induced by the accidental ingestion of food allergens, with antihistamines, cortisones and adrenaline. Ensuring a strict exclusion of the allergen from the diet can be problematic, with the risk of nutritional deficiencies, accidental exposure, cross-contamination or caused by incorrect labeling of processed food products. At the same time, the daily management of a correct elimination diet and a possible allergic reaction, entail a significant burden and high levels of anxiety and stress associated with uncertainty about the management of anaphylaxis, in the parents of children with FA, particularly in mothers, resulting in an impact on Quality of Life (QoL). The availability of a multidisciplinary team made up of pediatricians, allergists and dietitians / nutritionists with experience in the field of FA could reduce the stress and anxiety of parents, while improving their QoL. Currently, for the evaluation of the quality of life of the parent of a child with AF, specific questionnaires for food allergies developed and validated in English are used: the food allergy self-efficacy scale for parents (FASE-P) and the Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB).

Condition or disease Intervention/treatment
Food Allergy Behavioral: Assessment of the quality of life of mothers of children with IgE-mediated food allergy

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of a Multidisciplinary Team on the Quality of Life of Mothers of Children With IgE-mediated Food Allergy
Actual Study Start Date : January 10, 2021
Actual Primary Completion Date : January 26, 2021
Estimated Study Completion Date : January 10, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Mothers of children with IgE-mediated food allergy diagnosed by a multidisciplinary team
Mothers of children with IgE-mediated FA diagnosed for at least 6 months who plan to visit a specialized level III center for the management of pediatric FA for the first time
 Behavioral: Assessment of the quality of life of mothers of children with IgE-mediated food allergy
  • Questionnaire on the demographic characteristics of the mother;
  • The food allergy self-efficacy scale for parents (FASE-P);
  • The Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB);
  • Food Allergy Quality of Life Questionnaire - Parent Form (children aged 0-12 years) (FAQLQ-PF)
Mothers of children with IgE-mediated food allergy diagnosed by a non-multidisciplinary team
Mothers of children with IgE-mediated AA diagnosed for at least 6 months who plan to undergo a follow-up visit at a specialized level III center for the management of FA in pediatric age which they have already been followed for at least 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Validate the Italian version of the food allergy self-efficacy scale for parents (FASE-P) [ Time Frame: 6 months ]
    The transversal validation of the Italian version of the scale will be evaluated by calculating the correlation between PHASE-P and FAQLQ-PF. The internal consistency will be evaluated by calculating Cronbach's α, identifying, on the basis of the literature, an acceptable correlation score <70%.


Secondary Outcome Measures :
  1. Validate the Italian version of the Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB) [ Time Frame: 6 months ]

    The cross-validation of the Italian version of the scale will be evaluated by calculating the correlation between FAQL-PB and FAQLQ-PF.

    The internal consistency will be assessed by calculating Cronbach's α, identifying, on the basis of the literature, an acceptable correlation score <70%.



Other Outcome Measures:
  1. Explore potential differences in the quality of life of mothers of children with IgE-mediated food allergy diagnosed by a multidisciplinary team or diagnosed by a non-multidisciplinary team [ Time Frame: 6 months ]
    The difference in QoL in the two cohorts will be evaluated by comparing the mean total scores of the three specific questionnaires for food allergies administered to the patient's mother (PHASE-P, FAQL-PB and FAQLQ-PF) and stratifying according to variables evaluated in the questionnaires and clinical data and demographics present in the patient's medical record.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mothers of children with IgE-mediated FA diagnosed for at least 6 months who plan to visit for the first time our Tertiary Center of Pediatric Allergology (University of Naples Federico II) and mothers of children already followed for at least 6 months by the same Center.
Criteria

Inclusion Criteria:

  • Adult mother of a patient <12 years of age diagnosed with IgE-mediated FA

Exclusion Criteria:

  • Mother's age <18 years
  • Mother unable to understand Italian
  • Mother suffering from chronic diseases
  • Mother suffering from epilepsy
  • Mother suffering from neoplasms
  • Mother suffering from immunodeficiencies
  • Mother suffering from chronic infections
  • Mother suffering from autoimmune diseases
  • Mother suffering from inflammatory bowel diseases
  • Mother suffering from functional gastrointestinal disorders
  • Mother suffering from celiac disease
  • Mother suffering from genetic-metabolic diseases
  • Mother suffering from tuberculosis
  • Mother suffering from congenital heart disease
  • Mother suffering from tuberculosis
  • Mother suffering from cystic fibrosis
  • Mother suffering from other chronic pulmonary diseases
  • Mother suffering from major malformations
  • Mother suffering from previous surgery of the cardiovascular / respiratory / gastrointestinal tract
  • Mother suffering from diabetes
  • Mother suffering from neuropsychiatric and neurological disorders
  • Mother suffering from eosinophilic disorders of the gastrointestinal tract
  • Mother not living with her child with FA
  • Concomitant presence in the child with FA of chronic diseases
  • Concomitant presence in the child with FA of epilepsy
  • Concomitant presence in the child with FA of neoplasms
  • Concomitant presence in the child with FA of immunodeficiencies
  • Concomitant presence in the child with FA of chronic infections
  • Concomitant presence in the child with FA of autoimmune diseases
  • Concomitant presence in the child with FA of inflammatory bowel diseases
  • Concomitant presence in the child with FA of functional gastrointestinal disorders
  • Concomitant presence in the child with FA of celiac disease
  • Concomitant presence in the child with FA of genetic-metabolic diseases
  • Concomitant presence in the child with FA of tuberculosis
  • Concomitant presence in the child with FA of congenital heart disease
  • Concomitant presence in the child with FA of tuberculosis
  • Concomitant presence in the child with FA of cystic fibrosis
  • Concomitant presence in the child with FA of other chronic lung diseases
  • Concomitant presence in the child with FA of major malformations
  • Concomitant presence in the child with FA of previous surgeries of the cardiovascular / respiratory / gastrointestinal tract
  • Concomitant presence in the child with FA of diabetes
  • Concomitant presence in the child with FA of neuropsychiatric and neurological disorders
  • Concomitant presence in the child with FA of eosinophilic diseases of the gastrointestinal tract
  • Concomitant presence in the child with FA of allergic diseases other than FA.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740632


Contacts
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Contact: Roberto Berni Canani, MD, PhD 0817462680 berni@unina.it

Locations
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Italy
Department of Traslational Medical Science - University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani, MD, PhD    0817462680    berni@unina.it   
Sponsors and Collaborators
Federico II University
More Information
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Responsible Party: Roberto Berni Canani, Associate professor- Chief of the Pediatric Allergy Program at the Department of Traslational Medical Science, Federico II University
ClinicalTrials.gov Identifier: NCT04740632    
Other Study ID Numbers: 283/20
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate