Ignite Creation Date:
2024-05-06 @ 9:44 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03051347
Status:
COMPLETED
Last Update Posted:
2020-10-09
First Post:
2017-02-09
Brief Title:
Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
AAD-PEPR Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments Sub-Study Clinically Relevant Endpoints in Atopic Dermatitis in Children CREAD-C--Funded by Regeneron
Status:
COMPLETED
Status Verified Date:
2020-10
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:
None
Brief Summary:
This is designated to validate patient-reported outcomes PRO measures in itch-specific pediatric skin conditions such as atopic dermatitis and examine the ability of a modified stigma instrument to assess the severity and type of stigma experienced in atopic dermatitis and other potentially stigmatizing conditions
Detailed Description:
This study involves a series of research and development projects targeted at two of the most common chronic diseases affecting children asthma and atopic dermatitis AD or eczema The Investigators propose to directly validate patient-reported outcomes PRO measures in a large cohort of itch-specific pediatric skin conditions with a primary focus on AD The Investigators propose to examine the ability of PROMIS Patient-Reported Outcomes Measurement Information Systems instruments to detect meaningful and clinically significant change in disease status as well as to create a pediatric itch item pool and PRO model for signs and symptoms of skin disease The Investigators will also examine the ability of a modified Neuro-QOL stigma instrument to assess the severity and type of stigma experienced in AD and across various dermatologic or other potentially stigmatizing conditions Lurie Childrens Hospital will only be involved in the AD and stigma portions of this project
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