NCT03051347

Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 943 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

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 Children's Hospital will only be involved in the AD and stigma portions of this project

Conditions

• Atopic Dermatitis
• Ichthyosis
• Psoriasis

Interventions

Type	Name	Description
OTHER	Itch Questionnaire and Interview
OTHER	Stigma Questionnaire and Interview
OTHER	Cognitive Interview and PROMIS Itch Questionnaire

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-02-09
• Completion: 2020-06-30
• First posted: 2017-02-13
• Last updated: 2020-10-09

Locations

1 site across 1 country: United States