Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook

Study Overview
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Brief Summary
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The objective of this research is to evaluate the effectiveness of an educational handbook for parents of children with atopic dermatitis (AD) in improving clinical outcomes for pediatric patients with AD and their parents. The handbook was developed by an interdisciplinary team of healthcare providers to facilitate therapeutic patient education as a routine component of care for pediatric patients with atopic dermatitis (AD). Patient education is an important element of practice management guidelines for AD, particularly given complex treatment plans and high rates of non-adherence in this population. Parents of children with AD will be randomized into either the handbook arm (handbook provided as an adjunct to standard AD management with a healthcare provider at Boston Children's Hospital) or the control arm (standard management alone). Participants will complete study measures at two time points: baseline (prior to a clinic visit appointment for AD care at Boston Children's Hospital), and 3-month follow-up. Data will be analyzed for change on study outcome measures (AD symptoms, AD severity, quality of life) and satisfaction with the handbook.

Official Title
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Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Other: Educational handbook


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of atopic dermatitis Scheduled for clinic visit for evaluation/management of atopic dermatitis at Boston Children's Hospital Exclusion Criteria: Parent is Spanish speaking Parent is foster parent

Ages Eligible for Study
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Minimum Age: 30 Days
Maximum Age: 16 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Handbook<br>handbook provided as an adjunct to standard AD management with a healthcare provider at BCH | Other: Educational handbook<br>* The intervention being evaluated in this study is an educational handbook for parents of children with atopic dermatitis (AD). The handbook was developed and written by the interdisciplinary study team (psychologist, allergist, nurse practitioner, dermatologists, primary care physician, dietitian). Content was based on practice guidelines for AD management, consensus recommendations for therapeutic patient education for AD, and clinical experience of our study team. Content includes topics central to effective AD management, such as pathophysiology/course, elements of treatment plans, and strategies to improve quality of life, such as breaking the itch-scratch cycle, improving sleep, and coping with social-emotional issues.<br>|
| No Intervention: Control<br>standard management alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Oriented Eczema Measure (POEM) | parent-report of child's atopic dermatitis symptoms | baseline to 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) | healthcare provider-rating of atopic dermatitis severity | baseline to 3-month follow-up | 
| Infant's Dermatitis Quality of Life Index (IDQOL) | Quality of life associated with atopic dermatitis (for patients under 4 years) | baseline to 3-month follow-up | 
| Children's Dermatology Life Quality Index (CDLQI) | Quality of life associated with atopic dermatitis (for patients 4-16 years) | baseline to 3-month follow-up | 
| Dermatology Family Impact Questionnaire (DFI) | Parent quality of life associated with atopic dermatitis | baseline to 3-month follow-up |