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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03722706
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Jennifer LeBovidge, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Other: Educational handbook Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Handbook
handbook provided as an adjunct to standard AD management with a healthcare provider at BCH
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.

No Intervention: Control
standard management alone



Primary Outcome Measures :
  1. Patient-Oriented Eczema Measure (POEM) [ Time Frame: baseline to 3-month follow-up ]
    parent-report of child's atopic dermatitis symptoms


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722706


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Pfizer
Investigators
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Principal Investigator: Jennifer S LeBovidge, PhD Boston Children’s Hospital

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Responsible Party: Jennifer LeBovidge, Attending Psychologist, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03722706    
Other Study ID Numbers: IRB-P00029317
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases