TY  - JOUR
AU  - Broome, Brantlee
AU  - Madisetti, Mohan
AU  - Prentice, Margaret
AU  - Williams, Kelli Wong
AU  - Kelechi, Teresa
PY  - 2021
DA  - 2021/3/3
TI  - 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
JO  - JMIR Res Protoc
SP  - e25805
VL  - 10
IS  - 3
KW  - caregiver well-being
KW  - food allergy
KW  - self-management
KW  - mhealth, randomizes mixed trial
KW  - caregiver
KW  - well-being
KW  - emergency room
KW  - smartphone app
KW  - smartphone
KW  - children
AB  - 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 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2021/3/e25805
UR  - https://doi.org/10.2196/25805
UR  - http://www.ncbi.nlm.nih.gov/pubmed/33656448
DO  - 10.2196/25805
ID  - info:doi/10.2196/25805
ER  -