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NCT04512924 · ClinicalTrials.gov registry record · NA
The Psychosocial Outcomes in Caregivers of Children With Food Allergy
A NA study of Caregiver Burnout and Psychosocial Problem, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04512924: Completed NA study of Caregiver Burnout and Psychosocial Problem, sponsored by Medical University of South Carolina.
NCT04512924 is a NA study of Caregiver Burnout and Psychosocial Problem that has completed, run by Medical University of South Carolina. The registered enrollment target is 30 participants, below the 162-participant average among 11 other Caregiver Burnout trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04512924, a NA study of Caregiver Burnout and Psychosocial Problem, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The PROMISED Interference (Short Form 6a) instrument measures the self-reported consequences of fatigue across aspects of life including social, cognitive, emotional, physical and recreational activities; this instrument refers to the past seven days. This validated scale has five response options, with scores ranging from one to five. Scores are converted to t-scores, and higher t-scores indicate greater pain interference. Higher scores represent greater degrees of fatigue. Scores \<55 within n
Conditions Studied
Interventions
- BEHAVIORAL Enhanced mobile app with standard of care and education
- BEHAVIORAL Enhanced mobile app with standard of care, education and support resources
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-12-08 |
| Est. Completion | 2022-04-30 |
| Phase | NA |
What the finished NCT04512924 record still lists
NCT04512924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 162-participant average among 11 other Caregiver Burnout trials with a reported enrollment target (81% lower).
The record links to 4 conditions, with Caregiver Burnout appearing as the primary indexed condition, and to 2 interventions - of which Enhanced mobile app with standard of care and education is the first listed.
NCT04512924 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT04512924 about?
NCT04512924 is a clinical study titled "The Psychosocial Outcomes in Caregivers of Children With 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...
What is the current status of trial NCT04512924?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2020-12-08. Estimated completion is 2022-04-30.
What conditions does trial NCT04512924 study?
This clinical trial studies the following conditions: Caregiver Burnout, Psychosocial Problem, Family Research, Food Allergy in Children.
What interventions are being tested in trial NCT04512924?
The interventions under investigation include: Enhanced mobile app with standard of care and education (BEHAVIORAL), Enhanced mobile app with standard of care, education and support resources (BEHAVIORAL).
Who is sponsoring clinical trial NCT04512924?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04512924 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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participants (enrollment target), bucketed by value
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