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Completed

NCT Number: NCT03051347

Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments

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.

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chicago, Illinois, 60611, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Itch Questionnaire and Interview

Other

Stigma Questionnaire and Interview

Other

Cognitive Interview and PROMIS Itch Questionnaire

Other

Primary outcomes

  1. Analysis and Coding of Itch & Stigma questionnaire Responses

    Time frame: 6 months duration of the study

  2. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 13, 2017
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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