Purpose

The primary objective of this randomized trial is to determine whether comprehensive, accessible, and animation-style videos are a more effective method of therapeutic patient education (TPE) based on clinical outcomes than paper handouts in Spanish and English-speaking communities. The clinical outcomes being measured are the severity, sleep affected by atopic dermatitis (AD), and the amount of itch experienced.

Condition

Eligibility

Eligible Ages
Under 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Boston Medical Center (BMC) patients under the age of 18 diagnosed with AD and their parents/legal guardian - Spanish or English speakers - Have access to the internet

Exclusion Criteria

  • None

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group 1- Printed educational materials
Parent-child dyads randomized to this group will receive printed educational materials in English or Spanish about atopic dermatitis.
  • Other: AD printed educational materials
    Printed educational materials in Spanish and English about coping with Atopic Dermatitis, specifically geared towards children and parents will be given to participants.
Experimental
Group 2- Educational videos
Parent-child dyads randomized to this group will receive an investigator developed educational video in English or Spanish about atopic dermatitis.
  • Other: AD educational videos
    Short, educational videos in English and Spanish about coping with Atopic Dermatitis, specifically geared towards children and parents will be developed. There will be Spanish and English versions of the videos, minimal text, comprehensive language, animations, and it will be administered via user friendly platforms or websites.

Recruiting Locations

BMC Pediatric Dermatology Clinics
Boston, Massachusetts 02118
Contact:
Margaret Lee, MD PhD
617-638-5500
Margaret.Lee@bmc.org

More Details

Status
Recruiting
Sponsor
Boston University

Study Contact

Margaret Lee, MD PhD
(617) 638-5500
Margaret.Lee@bmc.org

Detailed Description

Patients will be recruited, stratified, and then randomly assigned into one of two intervention groups.The patient participants will be children anywhere on the spectrum of mild to severe AD and they will be stratified into four strata: a) Those with severe AD and no medical intervention escalation, b) Those with mild AD and no medical intervention escalation, c) Those with severe AD and medical intervention escalation, and d) Those with mild AD and medical intervention escalation. Group 1 will be a paper handout for group 1 and an educational video for group 2 as a form of TPE. Subjects will be recruited in clinic after they are screened for AD during their regular dermatology appointment. The research team will provide the patient and parent with a brief introduction to the study, what it involves for the patient, any foreseeable risks, and the compensation. If they agree to participate, a consent/permission form will be given to the parent/guardian to sign. After an initial evaluation of the patient's AD, subjects will receive an initial survey and POEM questionnaire on an iPad via RedCap that will address the condition of their AD. The patient will be administered a form of TPE as the intervention. The intervention will first be viewed/read in clinic, followed by a brief set of questions from the research team to determine the amount of information retained on an immediate level. A follow-up appointment will be scheduled for the patient. Group 2 will receive a slip of paper with a link to the videos, so the TPE will be accessible outside the clinic.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.