Clinic-Based Atopic Dermatitis Therapeutic Patient Education (AD-TPE)

A Randomized Controlled Study of Clinic-Based Atopic Dermatitis Therapeutic Patient Education

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: AD printed educational materials; Other: AD educational videos

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • BMC Pediatric Dermatology Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in eczema severity based on the Patient Oriented Eczema Measure (POEM)	The Patient Oriented Eczema Measure (POEM) is a validated 7 item instrument with response categories from 0 to 4 where No days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3, Every day = 4. Scoring for the POEM ranges form 0 to 28 and is interpreted by 0 to 2 = Clear or almost clear, 3 to 7 = Mild eczema, 8 to 16 = Moderate eczema, 17 to 24 = Severe eczema, 25 to 28 = Very severe eczema.	baseline, up to 2 months
Change in eczema severity based on the Eczema Area and Severity Index (EASI)	The Eczema Area and Severity Index (EASI) is an investigator-assessed instrument measuring the severity of clinical signs in atopic dermatitis (AD). The suggested severity strata for the EASI are: 0 = clear; 0·1-1·0 = almost clear; 1·1-7·0 = mild; 7·1-21·0 = moderate; 21·1-50·0 = severe; 50·1-72·0 = very severe	baseline, up to 2 months
Change in the severity of itch	An investigator developed survey completed by participants with questions about itch will be used to collect data to assess this outcome.	baseline, up to 2 months
Change in sleep quality	An investigator developed survey completed by participants with questions about sleep quality will be used to collect data to assess this outcome.	baseline, up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the overall quality of life	An investigator developed survey completed by participants with questions about quality of life will be used to collect data to assess this outcome.	baseline, up to 2 months
Change in patient/parent confidence	An investigator developed survey completed by participants with questions about confidence will be used to collect data to assess this outcome.	baseline, up to 2 months
Change in knowledge of coping with Atopic Dermatitis (AD)	An investigator developed survey completed by participants with questions about their knowledge of coping with AD will be used to collect data to assess this outcome.	baseline, up to 2 months
Satisfaction with therapeutic patient education (TPE)	An investigator developed survey completed by participants with questions about their satisfaction about TPE will be used to collect data to assess this outcome.	up to 2 months
Atopic Dermatitis related costs	Billing records will be analyzed to assess AD related costs.	6 months

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Margaret Lee, MD PhD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): September 21, 2023
• Study Completion (Actual): September 21, 2023

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Educational videos; Therapeutic patient education; Printed handouts; Child-parent dyads
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: H-39538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No