Clinical trial NCT04512924: The Psychosocial Outcomes in Caregivers of Children With 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy in Children
Caregiver Burnout
Psychosocial Problem
Family Research
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2020-08-14
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in fatigue as assessed by Patient-Reported Outcomes Measurement Information System Fatigue short form
timeFrame: Baseline and 30 days
measure: Change in fatigue as assessed by Patient-Reported Outcomes Measurement Information System Fatigue short form
timeFrame: Baseline and 4 months
measure: Change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance short form
timeFrame: Baseline and 30 days
measure: Change in sleep disturbance as assessed by Patient-Reported Outcomes Measurement Information System Sleep Disturbance short form
timeFrame: Baseline and 4 months
measure: Change in depression as assessed by Patient-Reported Outcomes Measurement Information System Depression short form
timeFrame: Baseline and 30 days
measure: Change in depression as assessed by Patient-Reported Outcomes Measurement Information System Depression short form
timeFrame: Baseline and 4 months
measure: Change in anxiety as assessed by Patient-Reported Outcomes Measurement Information System Anxiety short form
timeFrame: Baseline and 30 days
measure: Change in anxiety as assessed by Patient-Reported Outcomes Measurement Information System Anxiety short form
timeFrame: Baseline and 4 months
measure: 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)
timeFrame: Baseline and 30 days
measure: 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)
timeFrame: Baseline and 4 months
measure: Change in caregiver quality of life-parental burden as assessed by the Food Allergy Quality of Life-Parental Burden (FAQoL-PB)
timeFrame: Baseline and 30 days
measure: Change in caregiver quality of life-parental burden as assessed by the Food Allergy Quality of Life-Parental Burden (FAQoL-PB)
timeFrame: Baseline and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
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.