Food Allergy Symptom Self-management With Technology (FASST) for Caregivers: An mHealth Intervention to Address Psychosocial Outcomes in Caregivers of Children With Newly Diagnosed Food Allergy
Phase: NA
Conditions: Food Allergy in Children, Caregiver Burnout, Psychosocial Problem, Family Research
Sponsor: Medical University of South Carolina

 
 
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PROTOCOL TITLE: Food Allergy Symptom Self-management with Technology (FASST) 
for Caregivers: An mHealth Intervention to Address Psychosocial Outcomes in Caregivers of 
Children with Food Allergy  
 
NCT04512924 
 
PRINCIPAL INVESTIGATOR: Dr. Brantlee Broome, PhD, MSN, RN (PI) 
 
Document Date: 5/7/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Specific Aims 
     Overview: Caregivers of children with life threatening severe food allergic reactions are more likely to 
experience fatigue, depression and anxiety. These distressing psychosocial conditions, in turn, may impact 
child and family functioning. Unfortunately, there is a paucity of self-management tools for caregivers to 
address these consequences. This proposal leverages advances in mHealth to develop and test such a tool. 
     Approximately 6 million US children suffer from food allergy 1, an immune response that occurs reproducibly 
upon exposure to a given food. Food allergy is one of the fastest growing national public health concerns with 
incidence at 8% of children and prevalence increasing by 50% between 1997 and 2011.2  Severe allergic 
reactions may include food-induced anaphylaxis (FIA), an acute life-threatening event affecting more than 40% 
of children diagnosed with food allergies.3 FIA can result in a rapid reaction that leads to circulatory collapse, 
coma, and death. Once a child experiences a food-induced reaction, of any severity, it is not possible to predict 
the severity of subsequent reactions but raises the risk of future fatal reactions.3  Between 2007 and 2016, FIA 
increased by 377% in the US, underscoring the need for better prevention and treatment 2 and for 
interventions to address significant distress experienced by caregivers of children with food allergies.4  
     Our recent preliminary research 4 corroborates findings in the literature 3; 5-11 suggesting that 32% of 
caregivers with a child who is newly diagnosed with food allergy(ies) experience clinically significant 
psychological distress.12 Symptoms and related factors include fatigue, anxiety, depressed mood, social 
isolation, stress, and substantially reduced quality of life. Despite recognition that family caregivers of children 
with severe food allergies experience fatigue, adverse psychosocial conditions and decreased quality of life, 
there is a lack of caregiver-centered self-management interventions to address these outcomes. Moreover, a 
lack of self-management interventions for these caregivers means that these distressing symptoms will likely 
persist.  
     To address this gap, we propose to develop an intervention that specifically targets fatigue and associated 
psychosocial symptoms. Bounce Back Now (BBN)13, an existing technology-enhanced, self-management 
mHealth intervention designed to address disaster survivors’ psychosocial health needs using a smartphone-
formatted approach, will be tailored and adapted for caregivers of children with food allergy(ies), hence the 
renaming to Food Allergy Symptom Self-Management with Technology (FASST) for caregivers. Over the 
course of 6-months, we will conduct preliminary feasibility testing of FASST in a 4-week small randomized trial 
of 30 caregivers of children 18 years-of-age who are newly diagnosed (90 days from diagnosis) with food 
allergy(ies).   
 
Aim 1a: Perform key informant interviews (n = 10) and analyze via conventional content analysis to determine 
ways to improve app acceptability. 
Aim 1b: Adapt FASST using data collected during key informant interviews. 
Aim 2:  Conduct preliminary testing of implementation processes including feasibility, acceptability, adherence 
and satisfaction using the RE-AIM framework with process measures, surveys, and key informant interviews in 
30 caregivers randomized to receive FASST (n = 20) or the control condition (i.e., basic app with resource 
links) (n = 10).  
Aim 3: Obtain estimates of variability and measure caregiver experienced fatigue, anxiety, depression, sleep, 
self-efficacy, and quality of life at baseline,  4-week intervention completion and 3-months post intervention. 
 
B. Significance 
B1. Food allergy is a highly complex condition and is growing in frequency and severity among 
children, negatively affecting quality of life.  
     Approximately 6 million children in the U.S. suffer from food allergy 1, and incidence is increasing.2 Food-
induced anaphylaxis (FIA) is a health risk associated with food allergy affecting more than 40% of children 
diagnosed with food allergies.3 FIA can result as a rapid reaction that leads to circulatory collapse, coma, and 
death. Once a child experiences a food-induced reaction, of any severity, it is not possible to predict the 
severity of subsequent reactions but raises the possibility of future fatal reactions. 3 Although FIA reactions in 
children are rare, they are responsible for over 200 deaths and 30,000 emergency room visits annually in the 
United States.14 There is no cure for food allergies and treatment involves avoidance of food allergens and 
emergency treatment of symptoms caused by accidental exposure.15 A caregiver’s ability to adhere to this 
standard of care may be challenged by a whole host of new factors that accompany the diagnosis, the most 
salient being the potential for a fatal reaction from ingestion of ubiquitous substances which are often invisible. 

 
 
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This creates an ever-present element of hypervigilance and stress-related fatigue as caregivers learn to 
manage food allergies as a chronic condition and as they learn to respond to food-induced reactions as an 
acute illness or event. Caregivers with newly diagnosed children are particularly challenged to balance 
appropriate vigilance and management strategies while tempering the effects of food allergy on quality of life.16 
B2. Caregivers experience symptoms that may reduce caregiving effectiveness.  
     The PI’s research, and that of others, highlights that caregivers of children with food allergy describe the 
physical challenges of care as overwhelming and constant. The perpetual hypervigilance and ensuing 
exhaustion associated with time-consuming and persistent condition-management activities – such as 
monitoring a child’s food consumption at school or when with friends, shopping for, and preparing special food 
– have the greatest impact on caregiver quality of life and are associated with fatigue, uncertainty, constant 
stress, social isolation, reduced spontaneity, and persistent anxiety, fear, and depression. 4-11 Following 
diagnosis, caregivers experience a period of psychosocial adjustment where these symptoms are most 
pronounced.17  As caregivers begin to understand the necessary precautions and potential consequences of 
accidental ingestion associated with FIA and the required condition-management activities, fear and anxiety 
emerge as the predominant emotions. While a certain level of anxiety is essential for adequate management, 
high levels of sustained anxiety in caregivers of children with food allergy may be maladaptive, increasing the 
overall burden of caring for a child with FIA and negatively impacting the caregiver’s ability to provide care to 
self, child, and family.18 
B3. Self-management strategies for caregiver stress and fatigue are lacking. 
     Despite recognition that family caregivers of children with severe food allergies are at risk for adverse 
consequences, decreased quality of life, and diminished caregiving effectiveness, there are a lack of caregiver-
centered self-management interventions to address stress-related fatigue, depression and anxiety symptoms. 
However, symptom self-management is exceedingly relevant to the caregiver of a child with newly diagnosed 
food allergy(ies) as management is complex and compounded by factors outside of the caregiver’s control 
which are further intensified by the lack of definitive treatment or cure. The short-term goal of this technology-
enhanced, self-management mHealth intervention is to enhance and promote effective self-management 
behaviors to improve the psychosocial well-being of the caregiver that in the long-term will lead to improved 
outcomes for the child, namely prevention of potentially fatal food induced reactions. 
              
C. Innovation 
     This proposal is innovative because it is the first to address psychosocial manifestations of 
caregiving to children with newly diagnosed food allergy(ies) using a technology-based self-
management scalable strategy that has the potential to be translated to other populations of caregivers of 
children with complex medical conditions.  This proposal: 
• 
Targets caregivers who are new to the disease process and management requirements and therefore 
have unique needs that will be addressed using a smartphone-formatted approach.  This demonstrates 
an innovative approach that is both cost effective and sustainable over time (fewer personnel required). 
• 
Focuses the intervention on psychosocial symptoms such as fatigue, addressing an unmet need 
recognized within the literature but neglected by providers.   
• 
Uses a scalable strategy to engage caregivers during a critical time-period in the caregiving/condition 
trajectory ( 90 days from diagnosis) when psychosocial functioning is most at risk. 
• 
Addresses barriers to accessing care such as transportation, work schedules, and childcare through 
the application of technology. Addressing these barriers lends to the translatability of the intervention to 
other populations of caregivers of children with complex medical conditions.  
• 
Uses a technology-based intervention that has been tailored based on caregiver-reported needs and 
desires and provider expertise which is expected to increase engagement and reach of self-
management strategy. 
 
D. Approach 
D1. Overview 
     This feasibility study is designed to modify an existing technology-enhanced, self-management mHealth 
intervention (BBN) and evaluate its impact on reach, self-management behaviors, caregiver psychosocial 
symptoms and quality of life targeting caregivers of children with newly diagnosed food allergy during the first 
90 days after diagnosis.  Our clinical sample will be recruited from the Medical University of South Carolina 

 
 
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(MUSC) Health Allergy and Immunology Clinic within the MUSC West Ashley Primary Care office. A sample of 
(n=10) caregivers of children with established food allergy ( 1 year from diagnosis) will be recruited for key 
informant interviews that will inform tailoring and adapting FASST.  Feasibility (rate of recruitment, attrition, rate 
of missing data, adoption, implementation, satisfaction, acceptability) will be tested in a randomized sample 
(n=30) of caregivers of children newly diagnosed with food allergy ( 90 days from diagnosis).  Participants 
(n=20) will be randomized to the experimental condition (FASST) or (n=10) to a control condition (i.e., basic 
app with resource links).  
     Participants randomized to the intervention arm (n=20) will receive the modified mHealth application 
(FASST) that contains elements of condition specific education and information, symptom self-monitoring, and 
symptom self-management.  Participants in the control arm (n=10) will receive the modified mHealth 
application (FASST) that contains only the element of condition specific education and information.       
D2. Investigative Team and Preliminary Work 
     This interdisciplinary team provides extensive, complementary expertise that will facilitate successful 
conduct of the proposed project. The primary mentor, Dr. Kelechi, a nurse scientist, has vast experience with 
developing rigorous feasibility and clinical trial management structure. Dr. Kelechi adds nursing expertise, 
theory-driven models, self-management/self-care, and expertise in intervention development and testing. Co-
mentor Dr. Ruggiero has a background in clinical psychology and is the Director of Technology Applications 
Center for Healthful Lifestyles (TACHL) and is PI on multiple NIH-funded grants. Fifteen of the federally funded 
grants that he has led as PI (including 5 NIH awards) have incorporated technology-based strategies and/or 
telehealth platforms to deliver interventions. Dr. Ruggiero brings experience with technology, telehealth, user 
centered design, intervention adaptation, as well as intervention development and testing. This includes 
development of web-based self-help interventions,19 as well as an iPad based intervention.20  Our clinical 
partner, Dr. Kelli Williams, is a board-certified pediatric allergy and immunologist with MUSC Health Allergy 
and Immunology, completed her residency in Pediatrics at MUSC and her fellowship in Allergy and 
Immunology at the National Institutes of Health, National Institute of Allergy and Infectious Diseases. While in 
fellowship, her research focused on rare immunologic and allergic diseases in both children and adults. Dr. 
Williams’ clinical interests include anaphylaxis and food allergy. Finally, Dr. Mueller, biostatistician, and co-
investigator on several NIH-funded projects, including several with Dr. Kelechi, will provide expertise in 
measurement strategies and statistical analyses. 
D3. Method 
D3.1. Setting, Sample and Recruitment. Prior to participant recruitment, we will tailor and adapt BBN  to 
FASST based on existing literature and expertise of the study team. We will then recruit 10 caregivers of 
children with established food allergy ( 1 year from diagnosis) to participate in key informant interviews that 
will inform the most practical changes needed when tailoring and adapting FASST prior to the intervention. We 
consider these key informant interviewees as co-designers of FASST as they possess a level of experience 
with and understanding of food allergy management and the psychosocial consequences of caring for a child 
during the critical period following a child’s food allergy diagnosis that caregivers of newly diagnosed children 
have yet to experience. Caregivers will be recruited via the Medical University of South Carolina (MUSC) 
Health Allergy and Immunology Clinic within the MUSC West Ashley Primary Care office. Caregivers will be 
recruited who have at least one child with an established food allergy(ies) diagnosis (1 year from diagnosis) 
and are familiar with the disease process and management as determined by: child has been seen at least 
every 12 months for one or more years. Dr. Williams will identify potentially eligible caregiver participants and 
will contact the caregiver, briefly describe the study, and ask permission for the principal investigator (Dr. 
Broome) or research assistant (RA) to contact the caregiver for screening. Once permission is granted, the PI 
or RA will contact the caregiver and assess for eligibility. Prior to consenting, all questions will be resolved to 
the patient’s satisfaction. If a participant does not appear to understand the information contained within the 
consent document or of what is expected of them as a study subject, then a member of the study team will 
review the consent document again with the participant. If after this second review, the subject does not 
demonstrate an understanding, they will not be enrolled in the study. Only participants, with no observed 
cognitive impairment, will be consented and enrolled into the study. 
Feasibility testing. Thirty caregivers of children with newly diagnosed ( 90 days from diagnosis) will be 
recruited into the feasibility Aim 2 of the study. Eligible caregivers will again be identified through the MUSC 
Health Allergy and Immunology Clinic. Inclusion criteria are as follows: caregivers of children 18 years-of-age 
who are newly diagnosed ( 90 days from diagnosis) with food allergy(ies). Only participants, with no observed 

 
 
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cognitive impairment, will be consented and enrolled into the study. To recruit participants for feasibility testing, 
Dr. Williams at the MUSC Health Allergy and Immunology Clinic will identify potentially eligible participants, 
explain study procedures, and if caregivers express interest, then will ask permission for the PI or RA to 
contact the potential participant. If permission is granted, the PI or RA will contact the potential participant to 
determine eligibility.  
D3.2. Intervention 
     The intervention will be a multicomponent (3-part) technology-based package delivered via a mobile device 
and used over a 4-week period. The intervention will target influences and processes informed by the 
Caregiving Process Model. Component 1 (education and support) will consist of continuous access to directed 
educational resources about food allergy and its management.  These materials will be easily accessible via a 
mobile device and will include embedded PDFs and links to websites developed and tested by authoritative 
sources. An example includes education materials provided by the Food Allergy Education and Research 
(FARE), the leading national organization and most trusted source of food allergy information, programs and 
resources, such as the Food Allergy & Anaphylaxis Emergency Care Plan. To address potential literacy 
barriers, all resources will be provided in a web compatible format and compliant with current accessibility 
guidelines. Component 2 (symptom monitoring and tracking) will consist of a mobile-device based application 
for daily tracking and monitoring of fatigue, anxiety and other psychosocial symptoms in caregivers of children 
with newly diagnosed food allergy(ies) that also permits upload of physical and emotional symptom logs to 
study personnel. The PI or RA will send a daily text reminder to participants randomized to the intervention arm 
of the study reminding them to complete their daily physical and emotional symptom log.  Logged symptom 
trends will be graphically illustrated by the application for participant viewing. Based on feedback from 
component 2, participants will be given directed guidance related to component 3 (symptom self-
management).  Component 3 will consist of symptom-based interventions participants can utilize real-time.  
For example, if a participant logs symptoms related to anxiety, the application will recommend a brief guided 
intervention for relaxation, such as meditation, or deep breathing.  If a participant logs symptoms related to 
fatigue, the application will recommend the participant listen to a short audio clip that offers ideas for achieving 
better sleep or suggestions for good sleep hygiene.  We will collect data via the app on the frequency and 
patterns of usage and will also collect measures data for Aim 3 at baseline, 4-weeks intervention completion 
and 3-months post-intervention completion. As well, the RA will send caregivers a weekly text message using 
a semi-structured protocol to “check in” with participants and promote engagement.  
D3.3. Control group 
     The control group will receive Component 1 of the intervention.   
D3.4. Primary Aim 1a and 1b: Key informant interviews and intervention tailoring and adaptation 
    We will use a purposive sampling strategy to identify caregivers of children with established ( 1 year from 
diagnosis) food allergy(ies) familiar with the disease process and management. Data obtained through key 
informant interviews using a semi-structured protocol and a qualitative descriptive approach21 will inform 
tailoring and adaptation of FASST. The purpose of interviews will be to obtain feedback from caregivers of 
children with established food allergy(ies) who have been managing the condition for one year or more.  
Participants will be asked about their experience in the first year of managing their child’s food allergy, with 
specific questions regarding the first 4 weeks of management and the perceived impact on their psychosocial 
well-being and overall quality of life. Participants will be shown a mocked-up application on a mobile device 
and asked to provide feedback related to the content.  At the beginning of the session, the PI will deliver 
detailed verbal instructions regarding use of the device and intervention components. Participants will be 
provided with mobile devices that have been prepared for the feasibility testing (Aim 2) with access to the 
FASST application and text messaging. After allowing time for participants to explore the intervention (with 
direct observation), the PI will ask 8-10 open-ended questions with probes using an interview guide. Questions 
will be designed to assess the acceptability, feasibility, and usability of the intervention. The interview will 
conclude with questions regarding suggested improvements to the intervention. The hands-on, observational 
session is expected to last 45 to 60 minutes and the interview is expected to last an additional 45 to 60 
minutes. The PI will video record observations to inform adaptation of the intervention. The interview will be 
audio recorded and transcribed. Following data analysis (described in D3.7.) the results from the interviews will 
be used to adapt the intervention to meet the specific needs of caregivers of children 18 years-of-age with a 
newly diagnosed food allergy(ies).  
 

 
 
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D3.5. Primary Aim 2: Feasibility Testing 
     To determine feasibility, we will apply the RE-AIM framework to assess the Reach, Efficacy, Adoption, 
Implementation, and Maintenance of the intervention with 30 caregivers.22 The domains are further explicated 
in Table 1. Participants will be asked to download the FASST app onto their mobile device with intervention 
components 1, 2, and 3 if randomized to the intervention arm and only component 1 if randomized to the 
control arm. The PI or RA will deliver detailed verbal instructions to the participants in both arms of the study 
on the use of the application and the respective intervention components. Participants will also receive written 
instructions and a contact number for technical assistance if needed. Baseline measures (Table 1) will be 
collected during the same meeting. Participants will participate in the intervention over a 4-week-period. At the 
end of the 4-week period, the PI will attend a post-intervention meeting with each individual caregiver 
participant during which measures data for Aim 3 will be collected. The PI will also collect frequency and 
patterns of usage data 3 months post-intervention to assess implementation and preliminary evidence of 
maintenance (Table 1).The PI will meet with the RA weekly during the intervention.  
Post-intervention interviews. Five participants from each study arm will be randomly selected and asked to 
participate in post-intervention key informant interviews with the PI to obtain more in-depth data on 
accessibility, usability, and adherence to intervention guided by the RE-AIM framework (Table 1). Semi-
structured interviews will be conducted in-person or via phone (participant’s choice) using a qualitative 
descriptive approach,21 will last approximately 45-60 minutes, and will be conducted according to an interview 
guide with open-ended questions and probes.  
     Reimbursement for participants will be a $50 gift card provided at each of the 3 data collection points, with 
participants in key informant interviews (pre- and post-intervention) receiving an additional $50 gift card.  
Measures. Caregivers will complete self-report measures at baseline, 4-week intervention completion, and 3 
months post-intervention. Self-report measures will be collected during meetings between the PI and the 
participant. Participants will complete measures using a mobile tablet device. Data will be captured using 
REDCap data management system.  The PI will be present to answer questions but will be unobtrusive while 
measures are completed.  
 
Table 1: Intervention Domains and Measures  
Major tasks and domains 
Measures/instruments/ 
questions and Cronbach’s alpha ( ) 
Data sources and time points 
Demographics/clinical 
characteristics 
Caregiver demographics including age, marital 
status, employment status, race/ethnicity, highest 
education level, and income;  child age, health 
history, race/ethnicity, medications, health care 
utilization, rural/urban residence, insurance, family 
characteristics 
Caregiver interview; baseline 
Reach:  
Sample  
Recruitment 
Monitoring of sample representativeness; types of 
recruitment activities; rates of recruitment; % eligible, 
consented, provided with informational session 
Recruitment tracking forms; 
quality checks by PI; weekly 
meetings with mentor, clinic staff, 
and research team 
Efficacy: 
Fatigue 
Emotional distress: anxiety 
Emotional distress: 
depressive symptoms 
 
Quality of Life 
 
Sleep Disturbance 
Self-Efficacy 
 
 
 
Measures of self-
management behaviors: 
 
PROMIS Fatigue SF 6a(>0.9)23 
PROMIS Emotional Distress: Anxiety 6a (0.97)24 
 
PROMIS Emotional Distress: Depressive symptoms 
SF 6a (0.97)25 
Food Allergy Quality of Life-Parental Burden 
(0.85)26 
PROMIS Sleep Disturbance SF 6a (0.9)27 
Food Allergy Self-Efficacy Scale for Parents (0.63-
0.89)28 
 
 
# days recorded symptoms; # days and types of 
recorded treatments/interventions 
 
Tracking forms; fidelity checklist; 
transmissions from web-based 
application to PI/RA; post-
intervention interviews; weekly 
meeting with mentor, clinic staff, 
and research team; baseline, 4-
weeks post-intervention, 3-
months post-intervention 

 
 
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Sample size considerations 
The purpose of this study is to establish feasibility of implementing the integrated intervention and obtain 
estimates of variability for efficacy outcomes, rather than to confirm or refute hypotheses. The proposed pilot 
study will recruit N=30 subjects for participation.  Because this is a pilot study and thus will not be testing 
hypotheses or proposing use of inferential statistics, a target sample size of 30 is appropriate.29 
 
D3.7. Data Analysis 
Qualitative analyses (Aim 1): Data from observational sessions and key informant interviews with caregivers 
and providers will be analyzed using conventional content analysis30 and nVivo qualitative data analysis 
software version 1031 to code data into common themes. These themes will be compared to the intervention 
and the components of the intervention will be adapted based on the thematic findings. A tree diagram may be 
used to identify the hierarchical structure of themes.  
Feasibility processes (Aim 2): For the feasibility trial, we will collect multiple measures informed by the RE-
AIM framework to assess feasibility and inform future efficacy and effectiveness trials. Variables will include 
those pertaining to the study procedures as well as participant variables. Data to be collected are described in 
Table 1. Specifically, 95% confidence intervals for proportions will be used to estimate dichotomous outcomes 
including the proportion of caregivers who agree to participate out of the number approached, the proportion 
adherent to the intervention protocol, i.e. providing daily symptom monitoring/tracking, using the education 
component, etc. For the continuous feasibility measures (e.g., patient satisfaction scores from patient surveys 
and end-of-study interview), frequency distributions and the median and mean responses (with 95% 
confidence intervals) will be obtained. 
Outcome measures and estimates of variability (Aim 3): Demographic and clinical variables obtained at 
baseline will be described via measures of central tendency (mean, median), variability and frequency 
distributions as appropriate. Additionally, demographic and clinical characteristics for those who adhered to the 
study protocol (study completers) versus those who did not adhere (non-adherers and drop-outs) will be 
compared to better describe the population for this study. For continuous measures for the caregiver (fatigue, 
anxiety, depression, quality of life, sleep disturbance, pain and self-efficacy), the difference between pre and 
post intervention measurements will be estimated via 95% confidence intervals.  
Monitoring and tracking 
symptoms 
Adoption: 
Adherence 
 
 
 
 
Acceptability  
 
 
Education 
 
 
Symptom monitoring and 
tracking 
# days symptoms recorded; # times problem-based 
intervention accessed; length of time in minutes 
problem-based intervention accessed; # times 
educational component accessed; length of time in 
minutes educational component accessed  
 
Caregiver satisfaction; # problems reported; types of 
problems reported 
 
# times accessed educational materials; length of 
time in minutes educational materials accessed 
 
# days recorded symptoms 
Tracking forms; data transmitted 
from web-based application; 
fidelity checklist; weekly 
meetings with mentor and 
research team; caregiver 
interview at end of study 
Implementation: 
Technology 
 
 
Consistency of intervention 
 
# problems encountered with mobile device, # 
problems reported to research staff; types of 
problems reported 
instructional session conducted as planned; fidelity to 
protocol maintained 
 
Tracking forms; weekly meeting 
with mentor and research team; 
caregiver interview at end of 
study 
Maintenance: 
Projection of future 
adoption 
 
# caregivers who would continue intervention; 
caregiver perception of the intervention 
Caregiver interview at end of 
study; weekly meetings with 
mentor and team 

 
 
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Post-intervention qualitative analyses (Aim 2): Data collected from post-intervention key informant 
interviews will be analyzed using directed content analysis30 and nVivo qualitative data analysis software 
version 10.31 Consistent with the directed content analysis approach, initial coding categories are identified 
according to the guiding theoretical model, and for this study, will reflect the RE-AIM domains.   
 
 
D3.8. Timeline 
Activity 
Y1Q1 
Y1Q2 
Y1Q3 
Y1Q4 
Y2Q1 
Y2Q2 
Organization, IRB approval 
 
 
 
 
 
 
Adaptation of BBN to FASST 
 
 
 
 
 
 
Interviews with caregivers and providers  
 
 
 
 
 
 
Analysis of interview data 
 
 
 
 
 
 
Tailoring of FASST 
 
 
 
 
 
 
Recruitment  
 
 
 
 
 
 
Intervention delivery (with assessments) 
 
 
 
 
 
 
3-month follow up assessments 
 
 
 
 
 
 
Data analysis, manuscript preparation, grant 
submission 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Provisions to Monitor the Data to Ensure the Safety of Subjects 
There is a well-developed and NIH/NINR prepared DSMP that involves the use of a Safety Monitoring 
Committee (SMC) that shall meet semi-annually post initial study enrollment. The Committee is comprised of 
key individuals that include: a safety monitoring committee chair (SMCC), a biostatistician (BS), and the 
Program Manager (PM). Post initial study enrollment, the SMC will convene semi-annually and all reports will 
be forwarded to the IRB and Sponsor in accordance with institutional policies and sponsor requirements. 
 
SECTION A. Safety Monitoring Committee (SMC) 
The study’s SMC will be comprised of the following individuals, who will perform data safety management and 
monitoring of the study: 
Susan Newman, PhD, RN, CRRN Safety Monitoring Committee Chair (SMCC) 
Martina Mueller, PhD Biostatistician (BS) 
Mohan Madisetti, MSc. Program Manager (PM) 
 
Individual Roles and Responsibilities 
Principal Investigator, (PI). Although not part of the SMC, as PI, Dr. Broome will overall be responsible for the 
immediate protection of all human participant study participants enrolled in the study. 
 
Safety Monitoring Committee Chair (SMCC). Dr. Newman is an Associate Professor and the Director of the 
Ph.D. in Nursing Science program in the College of Nursing. Dr. Newman is a Certified Rehabilitation 
Registered Nurse currently researching the role of peer mentoring in the process of adapting to life with a spinal 
cord injury.  Her work has been supported by the National Institutes of Disability, Independent Living and 
Rehabilitation Research, National Institutes of Health, and the Agency on Healthcare Research and Quality.  Dr. 
Newman will act as the study’s Safety Monitoring Committee Chair (SMCC). Dr. Newman has no real or 
apparent conflict of interest that would affect her performance in this role on the study. Dr. Newman will 
correspond semi-annually with the SMC to review de-identified cumulative AE study data to assess any impact 
on the safety of participants or on the ethics of the study. As the SMCC she will be responsible for reviewing all 
cumulative reported SAE related to study treatment and data safety monitoring reports generated by the BS to 
provide study recommendations to the PI, MUSC’s IRB and NINR. Dr. Newman will be immediately notified of 
the occurrence of any SAE by the PI or PM and will be provided with the necessary study information to 
provide an informed recommendation in real-time regarding the protocol and human participant safety.  
 
Martina Mueller PhD, Biostatiscian (BS). Dr. Mueller is a Professor in the College of Nursing with a joint 
appointment in the Department of Biostatistics, Bioinformatics and Epidemiology (DBBE) at MUSC. Dr. Mueller 
has served and is currently serving as a member of several NIH/NINR R01/R21 DSM Boards, and Committees. 
Dr. Mueller will be responsible for conducting semi-annual interim analyses, generating semi-annual AE safety 
reports from the electronic study research database and disseminating de-identified information to the SMC. 
The interim data analyses will only include safety related results; analyses in regards to study outcome will not 
be performed. The interim AE reports will provide typology, frequency data and outcomes of all reported and 
documented AE in the electronic study database. With no patient contact, Dr. Mueller has no apparent conflict 
of interests to serve in this capacity. 
 
Mohan Madisetti MSc, Program Manager (PM). Mr. Madisetti is the P20 Progam Manager at the College of 
Nursing and a member of MUSC Institute of Human Values with Fellowship certification in Research Ethics. Mr. 
Madisetti has served and is currently serving as a member of several NIH/NINR R01/R21 DSM Boards and 
Committees, and FDA Industry Sponsored Clinical Trials. With no patient contact, Mr. Madisetti has no apparent 
conflict of interests to serve in this capacity. Mr. Madisetti will be responsible for the classification of all reported 
adverse events (AE) and for ensuring that all serious adverse events (SAE) are forwarded to the PI and SMC in 
real time and in compliance with MUSC IRB policies and procedures. In addition, and in conjunction with the PI, 
Mr. Madisetti will be responsible for amending the protocol in accordance with the SMC recommendations, 
submitting reportable SAEs and protocol deviations to MUSC IRB, and, submitting annual Progress Reports to 
the NIH/NINR through MUSC’s OSRP. He will also be responsible for maintaining the regulatory binder, 
ensuring data management validation and verification of the electronic study research database, conducting 
monthly internal quality control audits on all participant records, notifying the PI of any deficiencies, and the 

 
 
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forwarding of reportable SAE to the NIH/NINR Program Official through MUSC’s OSRP within 72hrs of IRB 
review and acknowledgement. 
 
SECTION B. Procedures for Safety, Risk and Confidentiality 
1. Monitoring Study Safety 
From the initial screening of participant by inclusion and exclusion criteria to the informed consent process to 
the provision of participant study instruction to staff training in Good Clinical Practices (GCP) and regulations 
pertaining to the Conduct of Human Participant Research to study contact with participants to internal monthly 
quality control audits and protocol fidelity monitoring to the real-time review of AE by the SMC to the oversight 
of MUSC’s IRB, procedures for monitoring study safety are consistently afforded throughout study. Specific 
study safety  procedures include: 
• 
Participants will be screened for inclusion and exclusion per the protocol; the PI or RA shall verify 100% 
of participants’ eligibility prior to study enrollment through review of inclusion and exclusion criteria with 
potential participants.  
• 
Participants will be fully informed as to all know risks and the possibility of risk from study participation in 
the informed consent process. These risks are minimal. 
• 
Participants will be instructed to notify the researchers of any/all suspected or experienced adverse 
events whether they believe them to be related or not to the intervention. 
• 
All reported participant AEs will be tracked through to resolution. 
• 
All investigators and researchers will maintain active CITI Human Subject Research and Good Clinical 
Practice training. 
• 
The PM will conduct a monthly internal quality control audit of all participant records to ensure 
compliance with MUSC IRB regulations; the PI and Program Coordinator (PC) will work together to 
correct any errors. 
• 
The PI and/or designee will observe and evaluate ten (10%) percent of eligibility screening visits, 
informed consents and study instructions performed by IRB approved study personnel and provide 
feedback and/or retraining of study personnel if fidelity to both applicable federal regulations and the 
protocol is not observed. 
• 
The BS willl generate semi-annual AE reports for the PI and SMC to review. 
• 
The SMC will have access to real-time study data and will be able to provide immediate 
recommendations to the PI. 
• 
Investigator performance and compliance will be provided for through MUSC IRB and ORI study 
oversight. 
 
2. Minimizing Research-Associated Risk 
Diligent study safety monitoring will be conducted by all member of the research team and the SMC throughout 
the conduct of this study in compliance with the following required elements of MUSC IRB’s continuing review 
process: 
• 
Tracking and follow-up of participant accrual (inc. withdrawn consents) will minimize risk by identifying, 
disclosing, and mitigating any potentially unknown risk(s) of harm to study participants.  
• 
Timely and appropriate reporting of informed consent process deficiencies, protocol deviations, privacy 
breaches, conflicts of interest, and/or changes in personnel. 
• 
Ongoing soliciting, monitoring and appropriate reporting of adverse event activities. 
• 
Timely and appropriate IRB submission of safety-related documents such as audit reports, sponsor 
progress reports, SMC reports, and other materials or communications that might impact the safe 
conduct of this study. 
• 
Active cooperation with the IRB, ACO, sponsor, and other applicable entities in the event of a random or 
for-cause internal or external audit. 
 
Institution-Wide Assurances 
This protocol will be conducted fully in keeping with the signed MUSC IRB Principal Investigator Statement of 
Assurance and Department Chair’s Statement of Assurance, when submitted to the IRB as a required 
component of the MUSC IRB Human Research Review Application.  

 
 
11 
 
3. Protecting Confidentiality of Participant Data 
Certificate of Confidentiality. This study will be conducted in accordance with recently enacted policy regarding 
the automatic granting of Certificates of Confidentiality to NIH/NINR  federally funded research. Participants will 
be made aware of their rights and the limitations of the release of Protected Health Information during the 
Informed Consent process. 
 
Participant Screening and Enrollment. All data from participants screened for the study will be entered into 
an electronic study database. Designated research staff will collect, gather, and enter required data (written 
informed consent, HIPAA Authorization, and demographics) onto study data forms. Screened patients who do 
not meet study eligibility will have specific screening data entered into the study database. The collected data 
will be helpful in examining the patient population and feasibility of enrollment criteria and will include reason for 
exclusion. All dates will be shifted and other Personal Health Information (PHI) will be removed from the study 
database upon study completion. All data obtained from this study will be used for research purposes only and 
will comply with Federal HIPAA regulations.  Master Screening and Enrollment Logs will used by the PM to 
prepare reports on accrual and attrition for the PI and SMC. 
 
Case Report Forms (CRF). All proposed study specific case report forms (source documents) for data 
collection will be designed by the PI, and, when possible, transferred into electronic Case Report Forms 
(eCRFs) for use in the study’s REDCap database. These study specific eCRFs source documents (study logs 
for correspondence, compensation and other forms such as pre-eligibility screens) will be coded by the 
participant’s unique study ID# for all data collected including study instruments will be maintained in the 
participant research record. Completed instruments that require signature on a paper CRF will be scanned and 
uploaded into the study database to all for remote electronic safety monitoring as well as maintained on file in 
accordance with MUSC policies and applicable Federal Regulations for the Conduct of Human Participant 
Research.  
 
Binders. The PC will prepare and maintain a participant-specific CRF binder for each participant containing all 
non-eCRFs records. A regulatory file will be maintainedby the PM to include the IRB-approved Protocol, original 
Informed Consent documents, HIPAA forms and other required study-related regulatory documents. All paper 
research records and CRFs will be maintained in a locked file cabinet, stored in a room for research files that is 
accessible only via a password protected entry system that features security cameras, within the College of 
Nursing. Access to the research records, study database and PHI’s will be restricted to study personnel as 
approved by the PI and MUSC IRB. As with all studies conducted at MUSC, this study is also eligible for a 
random audit by MUSC Office of Compliance. 
 
Data Processing. This study will use Research Electronic Data Capture (REDCap) for data capture and 
management. REDCap is a software toolset and workflow methodology for the electronic collection and 
management of research and clinical trials data. REDCap provides secure, web-based, flexible 
applications, including real-time validation rules with automated data type and range checks at the time of 
data entry. Exports are made available for several statistical packages including SPSS, SAS, SATA, R and 
Microsoft Excel. The study-specific REDCap electronic database will be designed and developed by the PI, CI, 
or PC.  The provision of REDCap is made available through the South Carolina Clinical & Translational 
Research (SCTR) Institute at MUSC with NIH Grant awards UL1RR029882 and UL1TR000062.  
 
Data Security. Ensuring data security, compliance with 45 CFR 46 and maintaining the integrity of PHI is a top 
priority. MUSC has Standard Operating Procedures (SOP) to ensure a high level of data security while 
coordinating electronic and paper data management activities for clinical research trials. The REDCap study 
database will be hosted in the Biomedical Informatics secure data center at MUSC, a secure environment for 
data systems and servers on campus, and includes firewall, redundancy, failover capability, backups and 
extensive security checks. The secure data center has strict access control; only authorized core personnel 
may access the facility un-escorted. Only authorized users are allowed to connect to the network, and the 
security of the network is actively monitored.  Power and environmental controls have several layers of 
backups, from interruptible power supplies to alternate and redundant feeds to the local utility company. The 

 
 
12 
REDCap system administrator contributes to the maintenance of institutional disaster recovery and business 
continuity plans.  Load balancers and a highly fault tolerant SAN infrastructure contribute to high availability.  
 
The REDCap system itself has several additional layers of protection including password protection. Access to 
the data and its security is managed institutionally by sponsored login IDs through a Shibboleth login with an 
MUSC issued NetID and features a user account management filter that controls who can access the data and 
to what degree. All personnel must pass an employment background check before being issued an ID. 
Password complexity, history and expiration standards are implemented at the institutional level. Access to 
individual REDCap projects and their data is managed by the owner of the project. All transactions are 
securely delivered to the application using Secure Sockets Layer (SSL – SHA-1 with RSA Encryption; 2048-
bits). It is then transmitted internally (behind the firewall) to the database server. All transactions are logged at 
the server layer (httpd logging), application layers (REDCap logs activity to a database table), and the 
database layer, using both query and binary logging. This feature provides audit trails for all changes, queries, 
data exports and reports. MUSC Information security policies are available at: https://mainweb-
v.musc.edu/security/policy/  
 
Data Entry. Only MUSC IRB approved study personnel that are authorized to have access to the REDCap 
study database will be granted password access. Study personnel using computers that are connected to the 
Internet will directly enter data into the remotely housed database. As such, no electronic study data will be 
stored on hard drives and/or any portable electronic devices. Additionally, all personnel with access to the 
database will have current University of Miami CITI training in the Conduct of Human Subject Protections, and 
HIPAA and Information Security trainings that are completed annually. Each participant will be assigned a 
unique study identifier, all PHIs will be masked, and data exports will be limited to the PI or the PC for 
generating reports and the conduct of statistical data analysis. 
 
Data Monitoring. Ongoing quality control procedures will be implemented for data collection, storage and 
processing. The PM will conduct routine monitoring of the study database and generate a monthly report for 
review at study team meetings. Standing agenda items for these meetings will include participant recruitment 
and retention, AE’s, protocol deviations, data integrity and overall study conduct. The PI and PC will work to 
resolve and validate discrepant data. Discrepancies that warrant clarification will be sent to appropriate parties 
for review and resolution. All data entry and changes made in the study database by authorized study 
personnel will be automatically logged by REDCap, and provide a transparent visible audit trail for reviewers. 
 
SECTION C. Procedures for Identifying, Reviewing and Reporting Adverse Events 
1. Identifying. Potential minimum risks identified for participants are outlined in the Protection of Human 
Participants and will also be outlined in the IRB-approved informed consent document. Additional unknown 
risks may occur and, if so, will be identified through diligent monitoring by the PI or PC throughout the 
conduct of this study. During the informed consent process, participants will be advised of the potential 
risks of participation as identified in the IRB-approved informed consent document and reminded 
throughout the study that the researchers should be promptly informed about any concerns regarding 
potential side effects, adverse events, or clinical deterioration. Participants will also be instructed to notify 
the PI, PC, and/or designee of any suspected adverse events immediately if possible. The PI or PC will 
maintain an electronic record of all reported adverse events and notify the SMC of all reportable events as 
they occur. The SMC will have real-time access to the study database to review and monitor all reported 
SAE that were reported as related to the intervention. Additionally, the BS will generate and provide de-
identified cumulative administrative human participant semi-annual safety reports for the SMC to review. 
 
 
2. Reviewing. Adverse events will be initially be assessed and graded by PM and then reviewed by the 
members of the SMC according to the following MUSC’s IRB Adverse Event Reporting Policy  
http://academicdepartments.musc.edu/research/ori/irb/HRPP/HRPP Guide Section 4.7 
• 
Expected/Anticipated—Identified in nature, severity, or frequency in the current protocol, informed 
consent, investigator brochure, or with other current risk information. 
• 
Unexpected/Unanticipated—Not identified in nature, severity, or frequency in the current protocol, 
informed consent, investigator brochure, or with other current risk information. 

 
 
13 
• 
More Prevalent—Occurs more frequently than anticipated or at a higher prevalence than expected. 
• 
Serious—Results in death, is life threatening, requires inpatient hospitalization or prolongs existing 
hospitalization, results in persistent or significant disability/incapacity, cancer, overdose, or causes a 
congenital anomaly/birth defect. 
 
The relationship of adverse events to study participation will be determined by the SMC according to the MUSC 
IRB Adverse Event Reporting Policy: 
• 
Unrelated—There is not a reasonable possibility that the adverse event may have been caused by the 
drug, device or intervention. 
• 
Possibly Related—The adverse event may have been caused by the drug, device, or intervention, 
however there is insufficient information to determine the likelihood of this possibility. 
• 
Related—There is a reasonable possibility that the adverse event may have been caused by the drug, 
device or intervention. 
 
3. AE and UPIRSOS Reporting. All reportable AE and unanticipated problems (UPIRSOS) experienced by 
participants will be reported to the NIH/NINR and MUSC IRB in compliance with their Adverse Event 
Reporting Policy requirements, using the IRB's password protected on-line secure server adverse event 
reporting system. Within 24 hours after a reportable AE, SAE or unanticipated problem has been reported 
by the participant, it will be graded by the PM, forwarded to the study’s SMC for review, and then will be 
submitted by the PI to MUSC IRB. The Institutional Official(s) will review the event and discuss the report 
with the IRB Chair and the Director of the Office of Research Integrity. After IRB review and 
acknowledgement, the PI will further review, and the PI or PM will forward a copy of the reportable AE, SAE 
or unanticipated problem and IRB acknowledgement letter to the NIH/NINR Program Officer through 
MUSC’s OSRP. The activities will be reported to the NIH/NINR within 72hrs. In addition, all cumulative 
reportable AE, SAE and unanticipated problems included in the SMC reports will be submitted to the 
NIH/NINR in the PI’s Annual Progress Reports. 
4. Examples of Potential Reportable Adverse Events: In accordance with MUSC IRB Adverse Event 
Reporting Policy, an AE is reportable is it meets all of the following criteria: 1) is unexpected 2) is related 
and/or possibly related, and 3) is serious and/or suggests that the research places subjects or others at a 
greater risk of physical or psychological harm than was previously known or recognized. Additionally, per 
MUSC’s policy all participant deaths, protocol deviations, complaints about the research, and breaches of 
confidentiality are reportable events. An example of an AE would be physical pain (symptom) that could 
potentially be associated with caregiving activities. The steps to be taken may include withdrawing the 
subject from the study and inviting him or her to restart the study after symptoms subside. An example of 
an SAE would be the death of a participant from acute chest syndrome, which although would be viewed as 
unexpected and unrelated to the intervention is nonetheless a reportable serious event. No further steps 
would be taken except to review, grade and report the event. An example of an unanticipated problem 
would be the participant trips and falls while retrieving their phone to read a text message reminder. The 
steps in this case would be to report the event as per the IRB and NINR policy, and to discuss appropriate 
actions regarding whether the participant should remain in the study with the SMC. These events and 
problems will be reported in accordance with the IRB and NIH/NINR policy as noted in Section C.3. 
 
SECTION D. Multi-site Monitoring and Compliance 
This is not a multi-site study. 
 
SECTION E. Assessment of External Factors 
The PI will conduct a semi-annual assessment of external factors through a review of literature related to new 
developments in the areas of food allergy caregiver self-management, symptom management (including anxiety 
and fatigue), symptom reporting and other approaches that may have an impact on the safety of participants or 
on the ethics of the study. To determine whether any changes are necessitated to the study protocol, the SMC 
will review any identified literature or product safety data that may pose as a potential impact to the risk benefit 
ratio study and/or safety of study participants. 
 
SECTION F. Interim Analysis 

 
 
14 
 
This study aims to test the feasibility of a multi-component, technology-based intervention to promote self-
management and symptom management among caregivers of children newly diagnosed with food allergy. To 
our knowledge, there are no similar interventions specifically designed for this population and purpose. As such, 
the PI and BS will generate semi-annual qualitative interim analysis reports on a) adverse events; and b) data 
obtained during phone end-of-study interviews to understand issues related to the uptake, usability, and 
adoption of this platform among this population. We will evaluate the screening and enrollment procedures, 
barriers to participation and retention, including, safety, adherence, acceptability, technology problems 
encountered if any, and user feedback from the participants and providers. This information gained from this 
structured process will be used to both guide the refinement of the current protocol and to inform the design of a 
larger efficacy trial. Interim analysis of outcome variables (fatigue, anxiety, and quality of life) was not 
considered to avoid inexact inferences and increased chance of error due to few data points, as well as 
potential for bias if interim results were known to the investigators. Therefore, there are no planned stopping 
rules for this study. 
 
Withdrawal of Subjects 
Participants may voluntarily elect to withdraw their consent at any time for any or no given reason while 
enrolled in the study. The PI may withdraw participants from the study at any time if they decide it is in the 
participant’s best interest, if they do not follow the investigator’s instructions, and/or if they fail to maintain to 
contact with the researchers or attend study visits. Withdrawals of participants may also occur if there is a 
protocol violation or early study closure. All data gathered from withdrawn participants will be used in the 
analysis plan under an Intention-to-Treat (ITT) model. 
 
 
Risks to Subjects 
The risks associated with this intervention are not considered greater than those that patients would otherwise 
be exposed to when receiving normal standard of care (SOC). However, as with all studies, there are inherent 
risks involved with the conduct of human subject research that gathers Protected Health Information (PHI). 
Participants will be made aware of these risks during the Informed Consent process. Identified study risks 
include: Loss of privacy, emotional distress, physical discomfort, and randomization.  
 
Loss of privacy: PHI from participants will be gathered and stored electronically on secure and encrypted 
servers and there are risks associated for the loss of privacy and confidentiality. We will further minimize the 
potential for loss of confidentiality through the physical separation of participant names from their research 
record according to the process described above. Audio recordings of participants interviews will be uploaded 
for transcription within 48 hours to an outside agency with which MUSC has established a Business Associates 
Agreement (BAA). Once uploaded, all audio recordings will be deleted from the portable storage device. 
 
Emotional distress: Some of the questions asked may be upsetting to participants or make them feel 
uncomfortable answering them. Participants will be instructed that if they do not wish to answer a question, 
they can skip it and go to the next question. 
 
Physical fatigue: Completion of the questionnaire and interview may be tiring to some participants.  
Participants will be given ample time to complete the questionnaire and may take breaks as necessary 
throughout the process.  
 
Randomization: Participants are being assigned to a study group by chance. The intervention included in the 
first study arm may prove to be less or more effective or have more or less or unknown side effects than the 
second study arm or other available treatments.  
 
Potential Benefits to Subjects or Others 
Because this proposal focuses symptom self-management for caregivers of children newly diagnosed with 
food allergy,  it does represent a potential immediate benefit to the caregiver due to the potential for improved 
psychosocial well-being. Furthermore, it is hoped that this proposal will contribute to generalizable scientific 

 
 
15 
knowledge and may change the management of food allergy in the future. A product developed with 
patient/provider engagement could be adopted en-masse and improve outcomes for caregivers, children, and 
families impacted by food allergy on a larger scale. Accordingly, the researchers view the anticipated risk 
benefit of study participation is favorable. 
 
Drugs or Devices 
This study does not involve the use or storage of any drug product. All investigational materials are readily 
commercially available and are not industry regulated.  
 
Dissemination Plan 
Purpose: This plan will ensure that all regulatory requirements are met in accordance with: 4.1.3.1 NIH Policy 
on Dissemination of NIH-Funded Clinical Trial Information designed to promote broad and responsible 
dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. 
Consistent with the expectations of this policy: 
1. Our clinical trial under the award will be registered and results information will be submitted to 
ClinicalTrials.gov as outlined in the policy and according to the specific timelines stated in the policy. 
2. The informed consent documents for our clinical trial will include a specific statement relating to posting of 
clinical trial information at ClinicalTrials.gov. 
3. The College of Nursing at the Medical University of South Carolina has an internal policy in place to ensure 
that clinical trials registration and results reporting occur in compliance with policy requirements. 
Specifically, the PI contacts the University’s Research Regulatory Coordinator who will assist with 
ClinicalTrials.gov registration as needed. Registration to ClinicalTrial.gov will be no later than 21 calendar 
days after the enrollment of the first study participants.  
The Research Regulatory Coordinator will also assist with posting result information that is not later than one 
year after the trial’s primary completion date.  
The Associate Dean for Research is also involved in this process as follows: reviews registrations, receives 
reports on clinical trials registration and compliance updates. 
The Medical University of South Carolina is committed to the open and timely dissemination of research 
outcomes. The Investigators involved in the proposed study recognize that promising new methods, 
technologies, data, software programs, and insights may arise during the course of their research. We are 
aware of and agree to abide by the principles for sharing research resources, as described by NIH in 
“Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and 
Disseminating Biomedical Research Programs”. 
During the course of the study, we plan to make presentations of interim results at national scientific meetings. 
Final research results will be published in a timely manner in scientific journals. Manuscripts to be submitted for 
publication will be accessible through the digital archive PubMed Central in compliance with the NIH Public 
Access Policy. Final non-restricted research data will be shared upon request following publication of the main 
findings. Final research data are defined as recorded factual material commonly accepted in the scientific 
community as necessary to document and support research findings. Datasets resulting from the proposed 
study will be redacted of any identifiers that would permit linkages to individual research participants and 
variables that could lead to deductive disclosure of individual participants. We will make the data and 
associated documentation available to users under a data-sharing agreement that provides for a commitment 
to using the data only for research purposes and not to identify any individual participant; a commitment to 
securing the data using appropriate computer technology; and a commitment to destroying or returning the 
data after analyses are completed. 
Sharing research results with study participants is a major priority at the Medical University of South Carolina. 
However, because this is a small pilot feasibility study, results from this project will not be shared with study 
participants.  We anticipate results from future projects stemming from this current work will be made available 
to study participants.   
 
 
 
 
 

 
 
16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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QSR International Pty Ltd. (2012). NVivo qualitative data analysis software (Version 10).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention Components and Content related to Caregiving Process Model 
 
Intervention 
Component 
Targeted Processes 
App Content 
1. Education and 
Resources 
Background and Context 
• 
Socioeconomic 
Status 
 
Caregiver Strain/Stress 
• 
Caregiving 
Demands 
• 
Perception of 
Formal Care 
 
 
 
 
 
 
Intervention provided using an accessible 
technology-based package delivered via a mobile 
device 
 
What is a Food Allergy?:  
https://www.foodallergy.org/life-with-food-
allergies/food-allergy-101/what-is-a-food-allergy 
 
Recognize and Respond to Anaphylaxis: 
https://www.foodallergy.org/sites/default/files/2017-
12/common-symptoms-poster_2017.pdf 
 
Symptoms of an Allergic Reaction to Food:  
https://www.foodallergy.org/life-with-food-

 
 
19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Coping Factors 
• 
Social Support 
allergies/food-allergy-101/symptoms-of-an-allergic-
reaction-to-food 
 
Medic Alert Bracelet: https://medicalalert.com 
 
Video clips reviewing the proper usage of auto-
injectable epinephrine 
Epi-pen: 
https://www.youtube.com/watch?v=FXlqSuzzrws 
AuviQ: 
https://www.youtube.com/watch?v=BhModQKXMTo 
 
How To Read Food Labels: 
https://www.foodallergy.org/life-with-food-
allergies/living-well-everyday/how-to-read-food-
labels 
https://www.kidswithfoodallergies.org/page/choosing-
safe-foods.aspx 
 
Food Allergy and Anaphylaxis Emergency Care 
Plan: (English and Spanish)  
https://www.foodallergy.org/life-with-food-
allergies/food-allergy-anaphylaxis-emergency-care-
plan 
 
Talking with Your Child about their Food 
Allergy:https://www.foodallergy.org/life-with-food-
allergies/newly-diagnosed/talking-to-children-about-
their-food-allergy  
 
 
Find a Support Group:  
https://www.foodallergy.org/education-
awareness/find-a-support-group 
 
Laws and Regulations: 
https://www.foodallergy.org/life-with-food-
allergies/newly-diagnosed/laws-and-regulations 
 
Reliable Websites: 
www.foodallergy.org 
www.kidswithfoodallergy.org 
http://www.aaaai.org/conditions-and-
treatments/allergies/food-allergies 
www.allergyhome.org 
 
2. Symptom Monitoring 
and Tracking 
Caregiver Strain/Stress 
• 
Caregiving 
Demands 
Intrapsychic Factors 
• 
Self-perception 
Daily text message will be sent to caregiver to 
remind him/her to log physical symptoms including: 
Fatigue/Trouble Sleeping 
Anxiety/Stress 
Pain/Body Aches/Headache 
Emotional/mood symptoms including: 
Depressed mood 
Overwhelm 

 
 
20 
 
 
Food Allergy and Anaphylaxis Emergency Care Plan 
 
Frustrated 
Worry 
 
All symptoms will be pictorially represented by 
emoticons in the app to aid with participant 
discrimination.   
 
Logged symptom trends will be graphically illustrated 
by the app for participant viewing. 
 
The app will permit upload of physical and emotional 
symptom logs to study personnel. 
3. Symptom Self-
management 
Coping Factors 
• 
Social Support 
• 
Stress 
Management 
• 
Family Function 
Based on feedback from component 2, participants 
will be given directed guidance related to component 
3. 
 
To address fatigue/trouble sleeping, participants will 
be directed to watch several short videos that focus 
on how to achieve better sleep; participate in guided 
imagery exercise; guided meditation. 
 
Anxiety and stress will be addressed through deep 
breathing exercises; guided relaxation; exercises to 
increase mindfulness. 
 
Altered emotional/mood states will be addressed 
through focused writing exercises within the app.  
For example, if a participant endorses negative 
emotions, they will be encouraged to log positive 
events/experiences and emotions to raise mood and 
esteem.  If a caregiver endorses “worry”, they will 
have the option to create a worry tree to help decide 
what worries are controllable and what to do about 
them.   
https://www.getselfhelp.co.uk/docs/worrytree.pdf 

 
 
21 
 

 
 
22 
 
 
 

 
 
23 
 
 
Interview Guide for Caregivers of Children with Food Allergy(ies) 
 
 
 “Thanks for agreeing to help us with our study.  We’d like to ask you a few questions about our program so we 
can continue to improve what we’re doing.”  
 
Parent/Caregiver Questions 
1.  Have you used a tablet computer, iPad, the internet, or a smartphone before? 
 
1.1  [If so] How often do you use one?  
 
1.2  [If so] When you use a tablet, iPad, the internet, or a smartphone, what types of things do you use it 
for? 
 
2.  Have you ever used technology such as a tablet, iPad, the internet, or a smartphone to help you manage your 
health or your child’s health? 
[if No, skip to 3.]  If yes, ask: 
 
2.1  What types of activities did you do on the tablet, iPad, internet or smartphone? 
 
2.2  How helpful was it / were they? What did you like about these activities?  Is there anything you 
didn’t like? 
 
2.3  What would make them better? 
 
3. “Great.  Thanks.  Now I’d like to ask you some questions about the activities we have for our program.  
Remember, there are no right or wrong answers.  The things that you tell us will help us improve the activities 
for other parents and caregivers. There are three main parts to the program.” 
 
 “The first part uses educational materials. They are located here [show them on tablet]. Experts in food allergy 
created them for caregivers. You can move from one page to the next, like this [show them on tablet]. Please 
take a few minutes to look them over. If you notice something you like or don’t like, or if something confuses 
you or catches your attention we would like to know about that.” [allow time for review] 
 
 
3.1  What do you like about them? 
 
 
3.2  What would make them better? 
 
3.3 Do you think these materials would be helpful to you? [if yes, How? If no, Why not?] [if needed: 
How could you see yourself using them to manage your child’s health?] 
 
4. “Thank you. The second part of the tablet activities is an app that helps keep track of how caring for a child 
with a food allergy may impact you. The app is located here [show them on tablet]. The app allows you to track 
any symptoms you may experience as someone caring for a child with a food allergy. Please take a few minutes 
to look over this part of the app. If you notice something you like or don’t like, or if something confuses you or 
catches your attention we would like to know about that.” [allow time for review] 
 
 
4.1 What did you like about this part of the app? 
 

 
 
24 
 
4.2 What would make this part of the app better? 
 
5. “Wonderful, thank you. The app also allows you to see on a graph how your symptoms may change over 
time [show them on tablet]. Please take a few minutes to look over this part of the app.” [allow time for review] 
 
5.1 What did you like about this part of the app? 
 
 
5.2 What would make this part of the app better? 
 
6. “Great, thanks. Now, let’s look at the last part of the app. This portion allows you to receive directed 
guidance on ways to address the symptoms you reported in the second part of the app.  For example, if you 
reported that you felt fatigued, the application will provide you with a brief audio clip that offers ideas to help 
you sleep better. Please take a few minutes to look over this part of the app.” [allow time for review]  As with 
the other parts of the app, if you notice something you like or don’t like, or if something confuses you or 
catches your attention we would like to know about that.” [allow time for review] 
 
6.1 What did you like about this part of the app? 
 
 
6.2 What would make this part of the app better? 
 
7. “Thank you again for reviewing each part of the app. The final piece of the program is communication with 
the study team. This will include receiving a daily text from the study team that will remind you to log your 
symptoms every day. The texting feature can be found here [show them on tablet]. We’ve sent some examples 
of what the daily texts will look like.” 
7.1 What did you like about the text messaging? 
 
 
7.2 What would make the text messaging better? 
 
8.  If you had the choice of using this program to help you better care for yourself and ultimately your child, 
would you want to use it? Why or why not? [if needed: How do you think you would use it? [e.g., how often, 
under what circumstances, etc.?] 
 
9. “Thank you so much for your help today. Is there anything else you can think of that you would like to share 
with us?” 
End interview, collect tablet, provide compensation.