Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any - 17
Updated:1/3/2019
Start Date:September 2016
End Date:February 2020
Contact:Dermatology CTU
Phone:312-503-5944

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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

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.

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

Inclusion Criteria:

- Affected children must have moderate to severe AD or another skin condition that
causes itch, experience itch, understand English, and be able to complete an
English-based survey

- Any child with a potentially disfiguring skin condition or change in appearance
related to disease/intervention will be considered eligible. Parents of children with
such conditions will also be asked to participate. Children and parents must also
understand English and be able to complete an English-based survey

Sub-study Inclusion Criteria:

1. Patients ages 8 years-17 years with a diagnosis of mild AD

2. Patients ages 6 months to 8 years with a diagnosis of AD (any severity)

3. English speaking

4. Families must be able to access the internet (e.g., Skype or Facetime) for follow-up,
or be able to come for follow-up within five days of an AD flare and again when
improved.

5. Patients with developmental delay and/or a behavioral disorder that would preclude
participation in form completion will not be eligible for this study.
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