Back to resultsThe Psychosocial Outcomes in Caregivers of Children With Food Allergy (FASST)
Primary Purpose
Food Allergy in Children, Caregiver Burnout, Psychosocial Problem
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced mobile app with standard of care and education
Enhanced mobile app with standard of care, education and support resources
Sponsored by
About this trial
This is an interventional supportive care trial for Food Allergy in Children
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1
Group 2
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04512924
First Posted
August 11, 2020
Last Updated
June 20, 2022
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT04512924
Brief Title
The Psychosocial Outcomes in Caregivers of Children With Food Allergy
Acronym
FASST
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy in Children, Caregiver Burnout, Psychosocial Problem, Family Research
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Title
Group 2
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Enhanced mobile app with standard of care and education
Intervention Description
Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced mobile app with standard of care, education and support resources
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in fatigue as assessed by Patient-Reported Outcomes Measurement Information System Fatigue short form
Description
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
Time Frame
Baseline and 30 days
Title
Change in fatigue as assessed by Patient-Reported Outcomes Measurement Information System Fatigue short form
Description
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
Time Frame
Baseline and 4 months
Title
Change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance short form
Description
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
Time Frame
Baseline and 30 days
Title
Change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance short form
Description
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
Time Frame
Baseline and 4 months
Title
Change in depression as assessed by Patient-Reported Outcomes Measurement Information System Depression short form
Description
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.
Time Frame
Baseline and 30 days
Title
Change in depression as assessed by Patient-Reported Outcomes Measurement Information System Depression short form
Description
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.
Time Frame
Baseline and 4 months
Title
Change in anxiety as assessed by Patient-Reported Outcomes Measurement Information System Anxiety short form
Description
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.
Time Frame
Baseline and 30 days
Title
Change in anxiety as assessed by Patient-Reported Outcomes Measurement Information System Anxiety short form
Description
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.
Time Frame
Baseline and 4 months
Title
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)
Description
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.
Time Frame
Baseline and 30 days
Title
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)
Description
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.
Time Frame
Baseline and 4 months
Title
Change in caregiver quality of life-parental burden as assessed by the Food Allergy Quality of Life-Parental Burden (FAQoL-PB)
Description
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.
Time Frame
Baseline and 30 days
Title
Change in caregiver quality of life-parental burden as assessed by the Food Allergy Quality of Life-Parental Burden (FAQoL-PB)
Description
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.
Time Frame
Baseline and 4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33656448
Citation
Broome B, Madisetti M, Prentice M, Williams KW, Kelechi T. 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. JMIR Res Protoc. 2021 Mar 3;10(3):e25805. doi: 10.2196/25805.
Results Reference
derived
Learn more about this trial
The Psychosocial Outcomes in Caregivers of Children With Food Allergy
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