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

Boston University

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: AD educational videos; Other: AD printed educational materials

Study type: Interventional

Funder types: Other

Identifiers

NCT04352270

H-39538

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Group 1- Printed educational materials

Active Comparator group

Description:

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

Treatment:

Other: AD printed educational materials

Group 2- Educational videos

Experimental group

Description:

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

Treatment:

Other: AD educational videos