Clinical trial NCT03051347: Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Ichthyosis
Psoriasis
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2017-02-13
Enrollment: 943
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Analysis and Coding of Itch & Stigma questionnaire Responses
timeFrame: 6 months duration of the study
measure: Validation of PROMIS Pediatric Instruments
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University and Lurie Children's Hospital Department of Dermatology
name: Amy Paller, MD
role: PRINCIPAL_INVESTIGATOR
References: