The Psychosocial Outcomes in Caregivers of Children With Food Allergy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate use of a mobile application (also commonly referred to as an app) designed to support caregivers of children with newly diagnosed food allergy. This study has 2 phases. In Phase 1, the researchers obtained feedback regarding use of mobile apps from caregivers who have been managing their child's food allergy for one year or more. The researchers then used this feedback to build a mobile app for caregivers of children with newly diagnosed food allergy. In Phase 2, the researchers will evaluate the mobile app during a 4-week evaluation period with a group of caregivers of children newly diagnosed with food allergy. The data obtained from this study will hopefully benefit caregivers of children with newly diagnosed food allergy.

Official Title
-----------------
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

Conditions
-----------------
Food Allergy in Children, Caregiver Burnout, Psychosocial Problem, Family Research

Intervention / Treatment
-----------------
* Behavioral: Enhanced mobile app with standard of care and education
* Behavioral: Enhanced mobile app with standard of care, education and support resources


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caregiver of child less than or equal to 18 years of age who are newly diagnosed (less than or equal to 90 days from diagnosis) with food allergy(ies). Exclusion Criteria: Caregiver with cognitive impairment/deficit and/or observed lack of understanding during the informed consent process
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br> | Behavioral: Enhanced mobile app with standard of care and education<br>* Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.<br>|
| Experimental: Group 2<br> | Behavioral: Enhanced mobile app with standard of care, education and support resources<br>* Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue as assessed by Patient-Reported Outcomes Measurement Information System Fatigue short form | The Patient-Reported Outcomes Measurement Information System Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The fatigue short forms are universal rather than disease-specific. A low score indicates low fatigue; high score indicates high fatigue | Baseline and 30 days | 
| Change in fatigue as assessed by Patient-Reported Outcomes Measurement Information System Fatigue short form | The Patient-Reported Outcomes Measurement Information System Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The fatigue short forms are universal rather than disease-specific. A low score indicates low fatigue; high score indicates high fatigue | Baseline and 4 months | 
| Change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance short form | The Patient-Reported Outcomes Measurement Information System Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep). The Sleep Disturbance short form is universal rather than disease-specific. It assesses sleep disturbance over the past seven days. A low score indicates low sleep disturbance; high score indicates high sleep disturbance | Baseline and 30 days | 
| Change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance short form | The Patient-Reported Outcomes Measurement Information System Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep). The Sleep Disturbance short form is universal rather than disease-specific. It assesses sleep disturbance over the past seven days. A low score indicates low sleep disturbance; high score indicates high sleep disturbance | Baseline and 4 months | 
| Change in depression as assessed by Patient-Reported Outcomes Measurement Information System Depression short form | The Patient-Reported Outcomes Measurement Information System Depression item banks assess self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher scores indicate negative mood; lower scores indicate more positive mode. The depression short forms are universal rather than disease-specific. It assess depression over the past seven days. | Baseline and 30 days | 
| Change in depression as assessed by Patient-Reported Outcomes Measurement Information System Depression short form | The Patient-Reported Outcomes Measurement Information System Depression item banks assess self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Higher scores indicate negative mood; lower scores indicate more positive mode. The depression short forms are universal rather than disease-specific. It assess depression over the past seven days. | Baseline and 4 months | 
| Change in anxiety as assessed by Patient-Reported Outcomes Measurement Information System Anxiety short form | The Patient-Reported Outcomes Measurement Information System Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. The anxiety measure is universal rather than disease-specific. It assess anxiety over the past seven days. Higher scores indicate higher levels of anxiety; lower scores indicate lower levels of anxiety. | Baseline and 30 days | 
| Change in anxiety as assessed by Patient-Reported Outcomes Measurement Information System Anxiety short form | The Patient-Reported Outcomes Measurement Information System Anxiety item banks assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. The anxiety measure is universal rather than disease-specific. It assess anxiety over the past seven days. Higher scores indicate higher levels of anxiety; lower scores indicate lower levels of anxiety. | Baseline and 4 months | 
| Change in caregiver self-efficacy related to managing food allergy in child as assessed by the Food Allergy Self-Efficacy Scale for Parents (FASE-P) | The FASE-P measures parental/caregiver confidence (self-efficacy) in managing food allergy in their child. Higher scores indicate better parental confidence; lower scores indicate lower parental confidence. | Baseline and 30 days | 
| Change in caregiver self-efficacy related to managing food allergy in child as assessed by the Food Allergy Self-Efficacy Scale for Parents (FASE-P) | The FASE-P measures parental/caregiver confidence (self-efficacy) in managing food allergy in their child. Higher scores indicate better parental confidence; lower scores indicate lower parental confidence. | Baseline and 4 months | 
| Change in caregiver quality of life-parental burden as assessed by the Food Allergy Quality of Life-Parental Burden (FAQoL-PB) | Food Allergy Quality of Life - Parental Burden Questionnaire (FAQoL-PB) is a 17-item measure that utilizes a 7-point Likert scale ranging from 1 (not troubled) to 7 (extremely troubled). Questions assess burden of food allergies as they relate to the caregiver's perceptions of meal preparation, social activities and food-allergy related worries and anxieties during the previous week. Higher scores indicate increased parental burden; lower score indicate decreased parental burden. | Baseline and 30 days | 
| Change in caregiver quality of life-parental burden as assessed by the Food Allergy Quality of Life-Parental Burden (FAQoL-PB) | Food Allergy Quality of Life - Parental Burden Questionnaire (FAQoL-PB) is a 17-item measure that utilizes a 7-point Likert scale ranging from 1 (not troubled) to 7 (extremely troubled). Questions assess burden of food allergies as they relate to the caregiver's perceptions of meal preparation, social activities and food-allergy related worries and anxieties during the previous week. Higher scores indicate increased parental burden; lower score indicate decreased parental burden. | Baseline and 4 months |