Clinic-Based Atopic Dermatitis Therapeutic Patient Education

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: AD printed educational materials
* Other: AD educational videos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1- Printed educational materials<br>Parent-child dyads randomized to this group will receive printed educational materials in English or Spanish about atopic dermatitis. | Other: AD printed educational materials<br>* Printed educational materials in Spanish and English about coping with Atopic Dermatitis, specifically geared towards children and parents will be given to participants.<br>|
| Experimental: Group 2- Educational videos<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic patient education, Printed handouts, Educational videos, Child-parent dyads