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

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722706
• Other study ID #: IRB-P00029317
• Status: Completed
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2020
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: March 30, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Oriented Eczema Measure (POEM)	parent-report of child's atopic dermatitis symptoms	baseline to 3-month follow-up
Secondary	Eczema Area and Severity Index (EASI)	healthcare provider-rating of atopic dermatitis severity	baseline to 3-month follow-up
Secondary	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
Secondary	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
Secondary	Dermatology Family Impact Questionnaire (DFI)	Parent quality of life associated with atopic dermatitis	baseline to 3-month follow-up