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Educational Materials for Eczema (AD-TPE Trial)

N/A

Waitlist Available

Led By Margaret Lee, MD PhD

Research Sponsored by Boston University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Boston Medical Center (BMC) patients under the age of 18 diagnosed with AD and their parents/legal guardian

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

AD-TPE Trial Summary

This trial is testing whether videos are a more effective method of patient education than paper handouts, based on clinical outcomes like the severity of atopic dermatitis, how much it affects sleep, and how much itchiness it causes.

Who is the study for?

This trial is for Boston Medical Center patients under 18 with Atopic Dermatitis (AD) and their parents or guardians, who speak Spanish or English and have internet access. There are no specific exclusion criteria.Check my eligibility

What is being tested?

The study is testing if animated videos are better than printed materials at teaching patients about AD management. It looks at how these methods affect the severity of AD, sleep quality, and itchiness levels in participants.See study design

What are the potential side effects?

Since this trial involves educational materials rather than medical treatments, there are no direct side effects associated with the interventions being tested.

AD-TPE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 18, diagnosed with AD, and a patient at BMC or I am their parent/legal guardian.

AD-TPE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in eczema severity based on the Eczema Area and Severity Index (EASI)

Change in eczema severity based on the Patient Oriented Eczema Measure (POEM)

Change in sleep quality

+1 more

Secondary outcome measures

Atopic Dermatitis related costs

Change in knowledge of coping with Atopic Dermatitis (AD)

Change in patient/parent confidence

+2 more

AD-TPE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 2- Educational videosExperimental Treatment1 Intervention

Parent-child dyads randomized to this group will receive an investigator developed educational video in English or Spanish about atopic dermatitis.

Group II: Group 1- Printed educational materialsActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor

454 Previous Clinical Trials

9,941,514 Total Patients Enrolled

Margaret Lee, MD PhDPrincipal InvestigatorBoston University

Media Library

AD educational videos Clinical Trial Eligibility Overview. Trial Name: NCT04352270 — N/A

Atopic Dermatitis Research Study Groups: Group 1- Printed educational materials, Group 2- Educational videos

Atopic Dermatitis Clinical Trial 2023: AD educational videos Highlights & Side Effects. Trial Name: NCT04352270 — N/A

AD educational videos 2023 Treatment Timeline for Medical Study. Trial Name: NCT04352270 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this research endeavor still open?

"The information available on clinicaltrials.gov indicates that the trial is still open for patient recruitment and has been since December 1st, 2022. The project seeks to find 560 participants from a single research site."

Answered by AI

How extensive is the sample size of this research?

"Affirmative, according to clinicaltrials.gov details, this trial is recruiting participants at the present time and was initially posted on December 1st 2022 with its most recent update taking place a month later. 560 people need to be recruited from one single centre for this study."

Answered by AI

What are the desired outcomes from this clinical research?

"This trial seeks to evaluate the efficacy of a therapeutic intervention through assessing changes in eczema severity, as measured by the Eczema Area and Severity Index (EASI), over a two-month period. Secondary objectives include evaluating participant/parental confidence, knowledge of coping with atopic dermatitis based on an investigator developed survey, and satisfaction with therapeutic patient education via another investigator developed questionnaire."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinic-Based Atopic Dermatitis Therapeutic Patient Education

2023. "Clinic-Based Atopic Dermatitis Therapeutic Patient Education". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04352270.