Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments

NCT03051347 | Completed

• 1 other identifier: ASP11022015
• Study Type: interventional
• Target: 943
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Ichthyosis; Psoriasis

Outcome Measures

Primary Outcomes (2)

• Analysis and Coding of Itch & Stigma questionnaire Responses

  6 months duration of the study

• Validation of PROMIS Pediatric Instruments

  1. 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. 2. 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. 3. By validating PROMIS, physicians and patients can decipher specific environmental stressors and illness flares that are clinically significant in the disease status.

  2 years

Study Arms (4)

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

Other: Itch Questionnaire and Interview

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

Other: Stigma Questionnaire and Interview

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.

Other: Cognitive Interview and PROMIS Itch Questionnaire

Validation Questionnaire and Interview-Mild

OTHER

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

Interventions

Itch Questionnaire and Interview OTHER

Itch Questionnaire and Interview

Stigma Questionnaire and Interview OTHER

Stigma Questionnaire and Interview

Cognitive Interview and PROMIS Itch Questionnaire OTHER

Validation Questionnaire and Interview-Mild; Validation Questionnaire and Interview-Moderate to Severe

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Ichthyosis; Psoriasis

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Abnormalities; Congenital Abnormalities; Infant, Newborn, Diseases; Keratosis; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amy Paller, MD

  Northwestern University and Lurie Children's Hospital Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: September 1, 2016
• Primary Completion: February 9, 2020
• Study Completion: June 30, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)