Atopic DermatitisNCT03051347
Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments
A study testing Itch Questionnaire and Interview, Stigma Questionnaire and Interview and Cognitive Interview and PROMIS Itch Questionnaire in people with Atopic Dermatitis and Ichthyosis, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Atopic Dermatitis, Ichthyosis, Psoriasis
- What is being tested?
- Itch Questionnaire and Interview, Stigma Questionnaire and Interview and Cognitive Interview and PROMIS Itch Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 943 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital
Chicago, Illinois, 60611
About this study
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
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.
Read the 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
- Being tested
- Itch Questionnaire and Interview, Stigma Questionnaire and Interview, Cognitive Interview and PROMIS Itch Questionnaire
- Medical subject headings
- Dermatitis, Atopic, Ichthyosis, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itch Questionnaire and InterviewOther
Stigma Questionnaire and InterviewOther
Cognitive Interview and PROMIS Itch QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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. Receives: Other: Cognitive Interview and PROMIS Itch Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis and Coding of Itch & Stigma questionnaire Responses
Measured: 6 months duration of the study
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study startSep 2016
- Primary completion9 Feb 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 943 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy Paller, MD, Principal investigator, Northwestern University and Lurie Children's Hospital Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051347
- Sponsor's protocol ID
- ASP11022015
- Status last verified
- Oct 2020
- First submitted
- 9 Feb 2017
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03051347
- Acronym / sponsor ID
- ASP11022015
- Conditions
- Atopic Dermatitis, Ichthyosis, Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 943 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Sep 2016 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Itch Questionnaire and Interview | Other | Other: Itch Questionnaire and InterviewUp 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 |
| Stigma Questionnaire and Interview | Other | Other: Stigma Questionnaire and InterviewTo 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 |
| Validation Questionnaire and Interview-Moderate to Severe | Other | Other: Cognitive Interview and PROMIS Itch QuestionnaireFor 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. |
| Validation Questionnaire and Interview-Mild | Other | Other: Cognitive Interview and PROMIS Itch QuestionnaireFor 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. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Analysis and Coding of Itch & Stigma questionnaire Responses
Time frame: 6 months duration of the study
Validation of PROMIS Pediatric Instruments
Time frame: 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Paller, MD principal investigator
Northwestern University and Lurie Children's Hospital Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Itch Questionnaire and Interview, Stigma Questionnaire and Interview and Cognitive Interview and PROMIS Itch Questionnaire in people with Atopic Dermatitis and Ichthyosis, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis and Coding of Itch & Stigma questionnaire Responses (time frame: 6 months duration of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.