PMID- 33656448
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210326
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 10
IP  - 3
DP  - 2021 Mar 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.
PG  - e25805
LID - 10.2196/25805 [doi]
LID - e25805
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.
CI  - (c)Brantlee Broome, Mohan Madisetti, Margaret Prentice, Kelli Wong Williams, Teresa 
      Kelechi. Originally published in JMIR Research Protocols 
      (http://www.researchprotocols.org), 03.03.2021.
FAU - Broome, Brantlee
AU  - Broome B
AUID- ORCID: 0000-0002-3451-1453
AD  - College of Nursing, Medical University of South Carolina, Charleston, SC, United 
      States.
FAU - Madisetti, Mohan
AU  - Madisetti M
AUID- ORCID: 0000-0002-1764-0149
AD  - College of Nursing, Medical University of South Carolina, Charleston, SC, United 
      States.
FAU - Prentice, Margaret
AU  - Prentice M
AUID- ORCID: 0000-0003-1045-309X
AD  - College of Nursing, Medical University of South Carolina, Charleston, SC, United 
      States.
FAU - Williams, Kelli Wong
AU  - Williams KW
AUID- ORCID: 0000-0003-2318-6023
AD  - College of Medicine, Medical University of South Carolina, Charleston, SC, United 
      States.
FAU - Kelechi, Teresa
AU  - Kelechi T
AUID- ORCID: 0000-0001-7412-2607
AD  - College of Nursing, Medical University of South Carolina, Charleston, SC, United 
      States.
LA  - eng
SI  - ClinicalTrials.gov/NCT04512924
GR  - P20 NR016575/NR/NINR NIH HHS/United States
GR  - UL1 RR029882/RR/NCRR NIH HHS/United States
GR  - UL1 TR000062/TR/NCATS NIH HHS/United States
PT  - Journal Article
DEP - 20210303
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC7970224
OTO - NOTNLM
OT  - caregiver
OT  - caregiver well-being
OT  - children
OT  - emergency room
OT  - food allergy
OT  - mhealth, randomizes mixed trial
OT  - self-management
OT  - smartphone
OT  - smartphone app
OT  - well-being
COIS- Conflicts of Interest: None declared.
EDAT- 2021/03/04 06:00
MHDA- 2021/03/04 06:01
PMCR- 2021/03/03
CRDT- 2021/03/03 12:13
PHST- 2020/11/17 00:00 [received]
PHST- 2021/01/21 00:00 [accepted]
PHST- 2021/01/05 00:00 [revised]
PHST- 2021/03/03 12:13 [entrez]
PHST- 2021/03/04 06:00 [pubmed]
PHST- 2021/03/04 06:01 [medline]
PHST- 2021/03/03 00:00 [pmc-release]
AID - v10i3e25805 [pii]
AID - 10.2196/25805 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2021 Mar 3;10(3):e25805. doi: 10.2196/25805.