Dermatitis, Atopic
Conditions
Brief summary
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.
Interventions
OTHEREducational handbook
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.
Sponsors
Pfizer
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Days to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Oriented Eczema Measure (POEM) | baseline to 3-month follow-up | parent-report of child's atopic dermatitis symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) | baseline to 3-month follow-up | healthcare provider-rating of atopic dermatitis severity |
| Infant's Dermatitis Quality of Life Index (IDQOL) | baseline to 3-month follow-up | Quality of life associated with atopic dermatitis (for patients under 4 years) |
| Children's Dermatology Life Quality Index (CDLQI) | baseline to 3-month follow-up | Quality of life associated with atopic dermatitis (for patients 4-16 years) |
| Dermatology Family Impact Questionnaire (DFI) | baseline to 3-month follow-up | Parent quality of life associated with atopic dermatitis |
Countries
United States
Outcome results
None listed