BACKGROUND: Approximately 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 .
OBJECTIVE: 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 .
METHODS: This 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 .
RESULTS: Phase I study activities have been completed, and Phase II participant enrollment into the randomized controlled trial is expected to commence in 2021 .
CONCLUSIONS: With 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 REGISTRATION: ClinicalTrials.gov Identifier NCT04512924: https: //clinicaltrials.gov/ct2/show/NCT04512924 . INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25805.
Index: caregiver, caregiver well-being, children, emergency room, food allergy, mhealth, randomizes mixed trial, self-management, smartphone, smartphone app, well-being