- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04512924
The Psychosocial Outcomes in Caregivers of Children With Food Allergy (FASST)
June 20, 2022 updated by: Brantlee Broome, Medical University of South Carolina
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
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
|
Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.
|
Experimental: Group 2
|
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.
|
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
Time Frame: Baseline and 30 days
|
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
Time Frame: Baseline and 4 months
|
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
Time Frame: Baseline and 30 days
|
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
Time Frame: Baseline and 4 months
|
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
Time Frame: Baseline and 30 days
|
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
Time Frame: Baseline and 4 months
|
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
Time Frame: Baseline and 30 days
|
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
Time Frame: Baseline and 4 months
|
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)
Time Frame: Baseline and 30 days
|
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)
Time Frame: Baseline and 4 months
|
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)
Time Frame: Baseline and 30 days
|
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)
Time Frame: Baseline and 4 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 8, 2020
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
August 11, 2020
First Submitted That Met QC Criteria
August 11, 2020
First Posted (Actual)
August 14, 2020
Study Record Updates
Last Update Posted (Actual)
June 24, 2022
Last Update Submitted That Met QC Criteria
June 20, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00100789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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