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OpenTrials
Completed

NCT Number: NCT03722706

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.

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Key information

Age range

30 day–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational handbook

Other

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.

Primary outcomes

  1. Patient-Oriented Eczema Measure (POEM)

    Time frame: baseline to 3-month follow-up

    parent-report of child's atopic dermatitis symptoms

Secondary outcomes

  1. Eczema Area and Severity Index (EASI)

    Time frame: baseline to 3-month follow-up

    healthcare provider-rating of atopic dermatitis severity

  2. Infant's Dermatitis Quality of Life Index (IDQOL)

    Time frame: baseline to 3-month follow-up

    Quality of life associated with atopic dermatitis (for patients under 4 years)

  3. Children's Dermatology Life Quality Index (CDLQI)

    Time frame: baseline to 3-month follow-up

    Quality of life associated with atopic dermatitis (for patients 4-16 years)

  4. Dermatology Family Impact Questionnaire (DFI)

    Time frame: baseline to 3-month follow-up

    Parent quality of life associated with atopic dermatitis

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2018
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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