Ignite Creation Date:
2024-05-06 @ 2:33 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04352270
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2020-04-13
Brief Title:
Clinic-Based Atopic Dermatitis Therapeutic Patient Education
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
A Randomized Controlled Study of Clinic-Based Atopic Dermatitis Therapeutic Patient Education
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AD-TPE
Brief 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
Detailed Description:
Patients will be recruited stratified and then randomly assigned into one of two intervention groupsThe 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 consentpermission form will be given to the parentguardian to sign After an initial evaluation of the patients 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 viewedread 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None