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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itch Questionnaire and Interview | Other | Up to 30 dyads of patients ages 8-17 and their parents/caregivers, as well as up to 20 parents of children ages 6mo-7 years, will participate in semi-structured interviews to evaluate the new and modified items (questions) written for the PIQ-C questionnaire |
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| Stigma Questionnaire and Interview | Other | To assess stigma, up to 20 children ages 8-17 and 20 parents of children ages 5-12, will participate in semi-structured interviews to evaluate the modified Neuro-QoL stigma questionnaire. This questionnaire includes new skin-specific stigma items and existing items modified for use with children having a skin or other condition that may negatively affect their appearance |
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| Validation Questionnaire and Interview-Moderate to Severe | Other | For validation, up to 200 parent/child dyads ages 5-17 with a diagnosis of moderate to severe AD during the previous 6 months will participate in teledermatology or in-person semi-structured interviews as follow-up to validate PRO measures in a large cohort of itch-specific pediatric skin conditions, specifically AD. Furthermore, this portion of the study will validate generic PROMIS measures of AD subjects' environmental stressors, illness flares, socio-demographic differences based on race/ethnicity and family income status. |
|
| Validation Questionnaire and Interview-Mild | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itch Questionnaire and Interview | Other |
| ||
| Stigma Questionnaire and Interview |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis and Coding of Itch & Stigma questionnaire Responses | 6 months duration of the study | |
| Validation of PROMIS Pediatric Instruments |
| 2 years |
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Inclusion Criteria:
Sub-study Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Paller, MD | Northwestern University and Lurie Children's Hospital Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D007057 | Ichthyosis |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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For validation, up to 90 parent/child dyads ages 0-17 with a diagnosis of mild AD will participate in teledermatology or in-person semi-structured interviews as follow-up to validate PRO measures in a large cohort of itch-specific pediatric skin conditions, specifically AD. Furthermore, this portion of the study will validate generic PROMIS measures of AD subjects' environmental stressors, illness flares, socio-demographic differences based on race/ethnicity and family income status for mild patients.
|
| Other |
|
| Cognitive Interview and PROMIS Itch Questionnaire | Other |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D007642 | Keratosis |
| D017444 | Skin Diseases, Papulosquamous |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |