Back to resultsAsthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments
Primary Purpose
Atopic Dermatitis, Ichthyosis, Psoriasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Itch Questionnaire and Interview
Stigma Questionnaire and Interview
Cognitive Interview and PROMIS Itch Questionnaire
Sponsored by
About this trial
This is an interventional other trial for Atopic Dermatitis
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
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.
Sites / Locations
- Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Itch Questionnaire and Interview
Stigma Questionnaire and Interview
Validation Questionnaire and Interview-Moderate to Severe
Validation Questionnaire and Interview-Mild
Arm Description
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
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
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.
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.
Outcomes
Primary Outcome Measures
Analysis and Coding of Itch & Stigma questionnaire Responses
Validation of PROMIS Pediatric Instruments
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03051347
First Posted
February 9, 2017
Last Updated
October 8, 2020
Sponsor
Northwestern University
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03051347
Brief Title
Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
February 9, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Ichthyosis, Psoriasis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
943 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Itch Questionnaire and Interview
Arm Type
Other
Arm Description
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
Arm Title
Stigma Questionnaire and Interview
Arm Type
Other
Arm Description
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
Arm Title
Validation Questionnaire and Interview-Moderate to Severe
Arm Type
Other
Arm Description
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.
Arm Title
Validation Questionnaire and Interview-Mild
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Itch Questionnaire and Interview
Intervention Type
Other
Intervention Name(s)
Stigma Questionnaire and Interview
Intervention Type
Other
Intervention Name(s)
Cognitive Interview and PROMIS Itch Questionnaire
Primary Outcome Measure Information:
Title
Analysis and Coding of Itch & Stigma questionnaire Responses
Time Frame
6 months duration of the study
Title
Validation of PROMIS Pediatric Instruments
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Paller, MD
Organizational Affiliation
Northwestern University and Lurie Children's Hospital Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments
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