NCT03722706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 26, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

October 25, 2018

Last Update Submit

July 16, 2020

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

  • Patient-Oriented Eczema Measure (POEM)

    parent-report of child's atopic dermatitis symptoms

    baseline to 3-month follow-up

Secondary Outcomes (4)

  • Eczema Area and Severity Index (EASI)

    baseline to 3-month follow-up

  • Infant's Dermatitis Quality of Life Index (IDQOL)

    baseline to 3-month follow-up

  • Children's Dermatology Life Quality Index (CDLQI)

    baseline to 3-month follow-up

  • Dermatology Family Impact Questionnaire (DFI)

    baseline to 3-month follow-up

Study Arms (2)

Handbook

EXPERIMENTAL

handbook provided as an adjunct to standard AD management with a healthcare provider at BCH

Other: Educational handbook

Control

NO INTERVENTION

standard management alone

Interventions

Educational handbookOTHER

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.

Handbook

Eligibility Criteria

Age30 Days - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of atopic dermatitis
  • Scheduled for clinic visit for evaluation/management of atopic dermatitis at Boston Children's Hospital

You may not qualify if:

  • Parent is Spanish speaking
  • Parent is foster parent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jennifer S LeBovidge, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Psychologist

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 29, 2018

Study Start

February 26, 2019

Primary Completion

March 15, 2020

Study Completion

March 30, 2020

Last Updated

July 17, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)