JMIR Publications

ABSTRACT

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. Clinical Trial: ClinicalTrials.gov Identifier NCT04512924 (posted 08/14/2020).