Clinic-Based Atopic Dermatitis Therapeutic Patient Education (AD-TPE)
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- STATUS
- Recruiting
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- End date
- Jun 16, 2023
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- participants needed
- 560
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- sponsor
- Boston University
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.
Details
| Condition | Atopic Dermatitis |
|---|---|
| Treatment | AD printed educational materials, AD educational videos |
| Clinical Study Identifier | NCT04352270 |
| Sponsor | Boston University |
| Last Modified on | 16 June 2022 |
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