Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments

NCT ID: NCT03051347

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 943 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-06-30

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

Conditions

Atopic Dermatitis; Ichthyosis; Psoriasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Itch Questionnaire and Interview

Intervention Type: OTHER

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

Group Type: OTHER

Stigma Questionnaire and Interview

Intervention Type: OTHER

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.

Group Type: OTHER

Cognitive Interview and PROMIS Itch Questionnaire

Intervention Type: OTHER

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.

Group Type: OTHER

Cognitive Interview and PROMIS Itch Questionnaire

Intervention Type: OTHER

Interventions

Itch Questionnaire and Interview

Intervention Type: OTHER

Stigma Questionnaire and Interview

Intervention Type: OTHER

Cognitive Interview and PROMIS Itch Questionnaire

Intervention Type: OTHER

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

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Amy Paller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Paller, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University and Lurie Children's Hospital Department of Dermatology

Locations

Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

ASP11022015

Identifier Type: -

Identifier Source: org_study_id