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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

Tracking Information
First Submitted Date  ICMJE October 25, 2018
First Posted Date  ICMJE October 29, 2018
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE February 26, 2019
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
Patient-Oriented Eczema Measure (POEM) [ Time Frame: baseline to 3-month follow-up ]
parent-report of child's atopic dermatitis symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • Eczema Area and Severity Index (EASI) [ Time Frame: baseline to 3-month follow-up ]
    healthcare provider-rating of atopic dermatitis severity
  • 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)
  • 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)
  • Dermatology Family Impact Questionnaire (DFI) [ Time Frame: baseline to 3-month follow-up ]
    Parent quality of life associated with atopic dermatitis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
Official Title  ICMJE Improving Therapeutic Patient Education for Atopic Dermatitis: Evaluation of a Parent Handbook
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Handbook
    handbook provided as an adjunct to standard AD management with a healthcare provider at BCH
    Intervention: Other: Educational handbook
  • No Intervention: Control
    standard management alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 29, 2020)
246
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2018)
240
Estimated Study Completion Date  ICMJE March 30, 2020
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03722706
Other Study ID Numbers  ICMJE IRB-P00029317
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jennifer LeBovidge, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Jennifer S LeBovidge, PhD Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP