Food Allergy Symptom Self-Management With Technology (FASST) mHealth Intervention to Address Psychosocial Outcomes in Caregivers of Children With Newly Diagnosed Food Allergy: Protocol for a Pilot Randomized Controlled Trial

Brantlee Broome, Mohan Madisetti, Margaret Prentice, Kelli Wong Williams, Teresa Kelechi, Brantlee Broome, Mohan Madisetti, Margaret Prentice, Kelli Wong Williams, Teresa Kelechi

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, 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://ichgcp.net/clinical-trials-registry/NCT04512924.

International registered report identifier (irrid): DERR1-10.2196/25805.

Keywords: caregiver; caregiver well-being; children; emergency room; food allergy; mhealth, randomizes mixed trial; self-management; smartphone; smartphone app; well-being.

Conflict of interest statement

Conflicts of Interest: None declared.

©Brantlee Broome, Mohan Madisetti, Margaret Prentice, Kelli Wong Williams, Teresa Kelechi. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.03.2021.

Figures

Figure 1
Figure 1
Phase II: CONSORT (Consolidated Standards of Reporting Trials) diagram of participant flow through the study.
Figure 2
Figure 2
Study SPIRIT diagram. FASST: Food Allergy Symptom Self-Management with Technology for Caregivers; PROMIS: Patient-Reported Outcomes Measurement Information System.
Figure 3
Figure 3
Sample Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) mobile health (mHealth) smartphone app screen image.
Figure 4
Figure 4
Sample Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) mobile health (mHealth) smartphone app screen image.

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