Clinic-Based Atopic Dermatitis Therapeutic Patient Education

Atopic Dermatitis Clinical Trial

— AD-TPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352270
• Other study ID #: H-39538
• Status: Completed
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: September 21, 2023

Study information

• Verified date: March 2024
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 21, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	BMC Pediatric Dermatology Clinics	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Atopic Dermatitis related costs	Billing records will be analyzed to assess AD related costs.	6 months