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Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 17 Years
Gender All
More Inclusion & Exclusion 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 Sub-study

Inclusion Criteria:

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03051347
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Northwestern University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Amy Paller, MD
Principal Investigator Affiliation Northwestern University and Lurie Children's Hospital Department of Dermatology
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Atopic Dermatitis, Ichthyosis, Psoriasis
Additional Details

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

Arms & Interventions

Arms

Other: 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

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

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.

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.

Interventions

Other: - Itch Questionnaire and Interview

Other: - Stigma Questionnaire and Interview

Other: - Cognitive Interview and PROMIS Itch Questionnaire

Contact a Trial Team

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Chicago, Illinois

Status

Recruiting

Address

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

Chicago, Illinois, 60611

Site Contact

Dermatology CTU

NUdermatologyCTU@northwestern.edu

312-503-5944

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