The Psychosocial Outcomes in Caregivers of Children With Food Allergy

Caregiver Burnout Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512924
• Other study ID #: 00100789
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Family Research
• Food Allergy in Children
• Food Hypersensitivity
• Hypersensitivity
• Psychosocial Problem

Intervention

Behavioral:
• Enhanced mobile app with standard of care and education
Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.
• Enhanced mobile app with standard of care, education and support resources
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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