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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Other: Educational handbook

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Handbook; handbook provided as an adjunct to standard AD management with a healthcare provider at BCH	Other: Educational 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.
No Intervention: Control; standard management alone

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Pfizer
• Investigators: Principal Investigator: Jennifer S LeBovidge, PhD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: IRB-P00029317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No