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

Not Applicable

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Other: Educational handbook

• Registration Number: NCT03722706
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Study Start: 2019-02-26
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Handbook	Educational handbook	handbook provided as an adjunct to standard AD management with a healthcare provider at BCH

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Dermatology Family Impact Questionnaire (DFI)	baseline to 3-month follow-up	Parent quality of life associated with atopic dermatitis
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)
Eczema Area and Severity Index (EASI)	baseline to 3-month follow-up	healthcare provider-rating of atopic dermatitis severity
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)

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States