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

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational handbook
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dermatitis, Atopic

Eligibility Criteria

30 Days - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Handbook

Control

Arm Description

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

standard management alone

Outcomes

Primary Outcome Measures

Patient-Oriented Eczema Measure (POEM)
parent-report of child's atopic dermatitis symptoms

Secondary Outcome Measures

Eczema Area and Severity Index (EASI)
healthcare provider-rating of atopic dermatitis severity
Infant's Dermatitis Quality of Life Index (IDQOL)
Quality of life associated with atopic dermatitis (for patients under 4 years)
Children's Dermatology Life Quality Index (CDLQI)
Quality of life associated with atopic dermatitis (for patients 4-16 years)
Dermatology Family Impact Questionnaire (DFI)
Parent quality of life associated with atopic dermatitis

Full Information

First Posted
October 25, 2018
Last Updated
July 16, 2020
Sponsor
Boston Children's Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03722706
Brief Title
Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
Official Title
Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Handbook
Arm Type
Experimental
Arm Description
handbook provided as an adjunct to standard AD management with a healthcare provider at BCH
Arm Title
Control
Arm Type
No Intervention
Arm Description
standard management alone
Intervention Type
Other
Intervention Name(s)
Educational handbook
Intervention Description
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 Outcome Measure Information:
Title
Patient-Oriented Eczema Measure (POEM)
Description
parent-report of child's atopic dermatitis symptoms
Time Frame
baseline to 3-month follow-up
Secondary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI)
Description
healthcare provider-rating of atopic dermatitis severity
Time Frame
baseline to 3-month follow-up
Title
Infant's Dermatitis Quality of Life Index (IDQOL)
Description
Quality of life associated with atopic dermatitis (for patients under 4 years)
Time Frame
baseline to 3-month follow-up
Title
Children's Dermatology Life Quality Index (CDLQI)
Description
Quality of life associated with atopic dermatitis (for patients 4-16 years)
Time Frame
baseline to 3-month follow-up
Title
Dermatology Family Impact Questionnaire (DFI)
Description
Parent quality of life associated with atopic dermatitis
Time Frame
baseline to 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer S LeBovidge, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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