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 mHealth smartphone app intervention 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 pre-formative 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 (diagnosed 1 year) will participate in semi-structured interviews to inform the development of the FASST app. In Phase II, 30 caregivers of children with a newly diagnosed food allergy (diagnosed 90 days) will be randomized 2:1 to receive FASST intervention (n = 20) or the 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 mesasured at baseline,week 4, and at 3-months post study completion.
RESULTS
Pre-formative Phase I study activities have been completed and Phase II participant enrollment into the randomized controlled trial is expected to commence 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.
CLINICALTRIAL
ClinicalTrials.gov Identifier NCT04512924 (posted 08/14/2020).
Food allergy symptom self-management with technology (FASST): An mHealth intervention to address psychosocial outcomes in caregivers of children with newly diagnosed food allergy: Protocol for a pilot randomized controlled trial. (Preprint)