Clinic-Based Atopic Dermatitis Therapeutic Patient Education

NCT04352270 | Completed

• 1 other identifier: H-39538
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Therapeutic patient education; Printed handouts; Educational videos; Child-parent dyads

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in the overall quality of life

  baseline, up to 2 months

• Change in patient/parent confidence

  baseline, up to 2 months

• Change in knowledge of coping with Atopic Dermatitis (AD)

  baseline, up to 2 months

• Satisfaction with therapeutic patient education (TPE)

  up to 2 months

• Atopic Dermatitis related costs

  6 months

Study Arms (2)

Group 1- Printed educational materials

ACTIVE COMPARATOR

Parent-child dyads randomized to this group will receive printed educational materials in English or Spanish about atopic dermatitis.

Other: AD printed educational materials

Group 2- Educational videos

EXPERIMENTAL

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

Interventions

AD printed educational materials OTHER

Printed educational materials in Spanish and English about coping with Atopic Dermatitis, specifically geared towards children and parents will be given to participants.

Group 1- Printed educational materials

AD educational videos OTHER

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.

Group 2- Educational videos

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

BMC Pediatric Dermatology Clinics

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Margaret Lee, MD PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 20, 2020
• Study Start: February 27, 2023
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)