The Psychosocial Outcomes in Caregivers of Children With Food Allergy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-08

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Food Allergy in Children Caregiver Burnout Psychosocial Problem Family Research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group 1

Group Type ACTIVE_COMPARATOR

Enhanced mobile app with standard of care and education

Intervention Type BEHAVIORAL

Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.

Group 2

Group Type EXPERIMENTAL

Enhanced mobile app with standard of care, education and support resources

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).