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

NCT03722706

Last updated date
Study Location
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-16
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of atopic dermatitis

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Parent is Spanish speaking


- Parent is foster parent

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Advanced Information
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2020)
246
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2018)
240
Actual Study Completion Date  ICMJE March 30, 2020
Actual Primary Completion Date March 15, 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, PhDBoston Children?s Hospital
PRS Account Boston Children?s Hospital
Verification Date July 2020

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