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

NCT03722706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2020-07-17

No results posted yet for this study

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.

Conditions

  • Dermatitis, Atopic

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jennifer S LeBovidge, PhD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Days
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2020-03-15
Completion
2020-03-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03722706 on ClinicalTrials.gov