Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments
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ClinicalTrials.gov Identifier: NCT03051347 |
Recruitment Status :
Completed
First Posted : February 13, 2017
Last Update Posted : October 9, 2020
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Condition or disease | Intervention/treatment | Phase |
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Atopic Dermatitis Ichthyosis Psoriasis | Other: Itch Questionnaire and Interview Other: Stigma Questionnaire and Interview Other: Cognitive Interview and PROMIS Itch Questionnaire | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 943 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | September 2016 |
Actual Primary Completion Date : | February 9, 2020 |
Actual Study Completion Date : | June 30, 2020 |

Arm | Intervention/treatment |
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Itch Questionnaire and Interview
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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Other: Itch Questionnaire and Interview |
Stigma Questionnaire and Interview
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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Other: Stigma Questionnaire and Interview |
Validation Questionnaire and Interview-Moderate to Severe
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.
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Other: Cognitive Interview and PROMIS Itch Questionnaire |
Validation Questionnaire and Interview-Mild
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.
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Other: Cognitive Interview and PROMIS Itch Questionnaire |
- Analysis and Coding of Itch & Stigma questionnaire Responses [ Time Frame: 6 months duration of the study ]
- Validation of PROMIS Pediatric Instruments [ Time Frame: 2 years ]
- This study results in the validation of the ability of PROMIS (Patient-Reported Outcomes Measurement Information Systems) instruments to detect significant change in disease status, to create a pediatric itch item pool and patient-reported outcomes (PRO) model for signs and symptoms of skin disease, specifically AD, in children of ages 6 months to 17 years.
- Through the research study to validate PROMIS, the physicians will derive an effective system which optimally and efficiently measures pain, depressive symptoms, anxiety, physical function-mobility, fatigue, peer relationships, psychological stress experiences, stigma, and new itch-specific measures in children ages 5-17 who suffer with moderate to severe AD and children ages 0-17 who suffer from mild AD.
- By validating PROMIS, physicians and patients can decipher specific environmental stressors and illness flares that are clinically significant in the disease status.

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Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Patients ages 8 years-17 years with a diagnosis of mild AD
- Patients ages 6 months to 8 years with a diagnosis of AD (any severity)
- English speaking
- 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.
- Patients with developmental delay and/or a behavioral disorder that would preclude participation in form completion will not be eligible for this study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051347
United States, Illinois | |
Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Amy Paller, MD | Northwestern University and Lurie Children's Hospital Department of Dermatology |
Responsible Party: | Amy Paller, Principal Investigator, Northwestern University |
ClinicalTrials.gov Identifier: | NCT03051347 |
Other Study ID Numbers: |
ASP11022015 |
First Posted: | February 13, 2017 Key Record Dates |
Last Update Posted: | October 9, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dermatitis, Atopic Ichthyosis Psoriasis Dermatitis Eczema Skin Diseases, Papulosquamous Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Skin Abnormalities Congenital Abnormalities Infant, Newborn, Diseases Keratosis |