Health Literacy for Children With Atopic Dermatitis and Their Caregivers

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of additional nursing instruction for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the University of Missouri Dermatology clinic.

Detailed Description
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The purpose of this study is to determine the effectiveness of additional nursing instruction for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the University of Missouri Dermatology clinic. Caregivers of children with atopic dermatitis will be randomized to one of two instruction/education procedures. The goal is to determine if improved retention of information by caregivers/parents of children with atopic dermatitis is associated with better patient outcomes.

Official Title
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Health Literacy for Children With Atopic Dermatitis and Their Caregivers

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Behavioral: Nurse instruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New clinical diagnosis of pediatric atopic dermatitis, or existing atopic dermatitis but new patient to MU dermatology Age 7 or under Exclusion Criteria: Age 8 or above

Ages Eligible for Study
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Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Physician/resident instruction<br>This arm is standard of care instruction given to parents/caregivers of children with atopic dermatitis by the dermatologist and/or dermatology resident during a patient visit. | |
| Active Comparator: Nurse instruction<br>Following the usual standard of care instruction by physician/resident (which both the treatment group and the non-treatment group will receive); the dermatology nurse will give enhanced instruction about skin care and medications to the caregivers/parents who were randomized to the treatment group. | Behavioral: Nurse instruction<br>* The dermatology nurse will give additional verbal and written instruction utilizing teach-back about skin care precautions and medication usage to the caregivers/parents in the treatment group.<br>* Other names: nurse teaching;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) | The Eczema Area and Severity Index is used to document extent and severity of atopic dermatitis on child's skin at the beginning of the study and again at the follow-up visit. The purpose is to determine improvement or lack of improvement following teaching intervention by nurses in the dermatology clinic. | EASI administered by blinded investigator at the initial visit, prior to teaching intervention; EASI again administered by same blinded investigator at visit 2 (at 4 weeks). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Questionnaire | A 27 item written questionnaire will be given to the parent/caregiver at visit 2. This questionnaire tests the retention of information given at visit 1 to subjects in both arms of the study (treatment and control group). | Visit 2 (or Week 4 visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric atopic dermatitis, EASI, REALM-SF, nurse instruction, health literacy