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Clinical Trials/NCT03722706
NCT03722706
Completed
Not Applicable

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

Boston Children's Hospital1 site in 1 country246 target enrollmentFebruary 26, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dermatitis, Atopic
Sponsor
Boston Children's Hospital
Enrollment
246
Locations
1
Primary Endpoint
Patient-Oriented Eczema Measure (POEM)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 26, 2019
End Date
March 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer LeBovidge

Attending Psychologist

Boston Children's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patient-Oriented Eczema Measure (POEM)

Time Frame: baseline to 3-month follow-up

parent-report of child's atopic dermatitis symptoms

Secondary Outcomes

  • Dermatology Family Impact Questionnaire (DFI)(baseline to 3-month follow-up)
  • Infant's Dermatitis Quality of Life Index (IDQOL)(baseline to 3-month follow-up)
  • Eczema Area and Severity Index (EASI)(baseline to 3-month follow-up)
  • Children's Dermatology Life Quality Index (CDLQI)(baseline to 3-month follow-up)

Study Sites (1)

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