Abstract
BackgroundApproximately 2.4 million children in the United States suffer from food-induced anaphylaxis, a condition that is annually responsible for over 200 deaths and 200,000 emergency room visits. As a result, caregivers of children newly diagnosed with severe and life-threatening food allergic reactions experience clinically significant symptoms of psychological distress, including fatigue, anxiety, depressed mood, social isolation, and substantially reduced quality of life. Despite this recognition, there is a lack of caregiver-centered self-management interventions to address these concerns.ObjectiveIn this protocol, we propose to develop and conduct feasibility testing of a technology-enhanced, self-management, mobile health, smartphone app intervention called Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) designed to meet the psychosocial health needs of caregivers of children with a new diagnosis of food allergy.MethodsThis pilot study uses qualitative work (Phase I) to inform a 4-week longitudinal randomized controlled trial (Phase II). In Phase I, 10 caregivers of children (≤18 years old) with established food allergy (≥1 year from diagnosis) will participate in semistructured interviews to inform the development of the FASST app. In Phase II, 30 caregivers of children (≤18 years old) with a newly diagnosed food allergy (≤90 days from diagnosis) will be randomized 2:1 to receive the FASST intervention (n=20) or control condition (basic app with educational resources; n=10). Process measures include feasibility, caregiver acceptability, adherence, and satisfaction. Outcome measures include caregiver fatigue, anxiety, depression, sleep, self-efficacy, and quality of life measured at baseline, week 4, and 3 months post study completion.ResultsPhase I study activities have been completed, and Phase II participant enrollment into the randomized controlled trial is expected to commence in 2021.ConclusionsWith limited readily available resources at their disposal, the results from this study have the potential to provide caregivers of children with a newly diagnosed food allergy a tool to help them self-manage and mitigate negative psychosocial factors during a critical time period in the caregiving/condition trajectory.Trial RegistrationClinicalTrials.gov Identifier NCT04512924: https://clinicaltrials.gov/ct2/show/NCT04512924International Registered Report Identifier (IRRID)DERR1-10.2196/25805
Highlights
In the United States, approximately 6 million children suffer from food allergies (FAs) [1], a major public health concern as its prevalence has continued to increase over the past 2 decades [2]
In this protocol, we propose to develop and conduct feasibility testing of a technology-enhanced, self-management, mobile health, smartphone app intervention called Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) designed to meet the psychosocial health needs of caregivers of children with a new diagnosis of food allergy
We propose a 2-phase pilot study to develop a mobile health smartphone app intervention called Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) that addresses psychosocial symptoms experienced by caregivers of children with newly diagnosed FA by providing targeted education and the ability to self-monitor and self-manage experienced symptoms
Summary
In the United States, approximately 6 million children suffer from food allergies (FAs) [1], a major public health concern as its prevalence has continued to increase over the past 2 decades [2]. There are many challenges to a caregiver’s ability to adhere to this standard of care—most notable is the potential for a fatal reaction from ingestion of food substances that are often invisible due to cross-contact with contaminated surfaces or the presence of unidentifiable food ingredients within processed foods This can create an ever-present and heightened state of vigilance, anxiety, and stress-related fatigue as caregivers learn to both manage FA as a chronic condition and respond to food-induced reactions as an acute illness or event. Caregivers of children newly diagnosed with severe and life-threatening food allergic reactions experience clinically significant symptoms of psychological distress, including fatigue, anxiety, depressed mood, social isolation, and substantially reduced quality of life. Despite this recognition, there is a lack of caregiver-centered self-management interventions to address these concerns. Symptom self-management is exceedingly relevant to the caregiver of a child with newly diagnosed FA(s) as condition management is complex and compounded by factors outside of the caregiver’s control and is further intensified by the lack of definitive treatment or cure
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