ClinPRO-AD: Clinical and Patient-reported Outcomes in Patients With Atopic Dermatitis
Study Details
Study Description
Brief Summary
This study will follow patients diagnosed with atopic dermatitis (AD), also known as eczema, to learn important information about how the disease and its treatments impact patients over time. The study will attempt to help inform the best clinical management of patients with atopic dermatitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The study is a multi-center, longitudinal, observational study to describe Clinician Reported Outcomes (ClinROs) and Patient Reported Outcomes (PROs) in AD patients. This study will collect data using validated clinical instruments and patient-reported data on the disease course of AD, including symptom assessments and Quality of Life (QoL) measures from a patient perspective, to supplement routine clinical data collected from their healthcare providers. ClinROs will be collected at baseline and at routine follow-up visits for up to two years. PROs will be collected directly from patients at baseline and at 3-6 month intervals for the duration of the study outside of clinic visits. In moderate-to-severe AD patients initiating systemic therapy, an additional PRO time-point at 6 weeks will be included to better understand early treatment effects.
Specific study aims:
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To describe longitudinal changes in disease activity, symptom control and health-related quality of life (HrQoL) based on both ClinROs and PROs
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To identify patient, disease and treatment factors associated with changes in PROs over time
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To describe the association between PROs and clinical outcomes
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1: Mild-to-Moderate AD Cohort 1 is limited to patients clinically diagnosed with mild-to-moderate AD. PROs will be collected via seven validated measures. All seven instruments will be collected at baseline. Follow-up will occur in 3-6 month intervals and the questionnaires collecting PRO data will be presented in a staggered method at each interval to reduce patient burden. |
Other: N/A This is an observational study
As this is an observational study, there are no interventions assigned to either cohort.
|
| Cohort 2: Moderate-to-Severe AD and initiating new therapy Cohort 2 is comprised of patients that receive a clinical diagnosis of moderate-to-severe AD and are newly initiating an advanced systemic therapy for AD. Patients in this cohort will receive the same PRO measures and at the same timepoints as Cohort 1. However, this cohort will receive an additional set of measures at six weeks post treatment initiation. |
Other: N/A This is an observational study
As this is an observational study, there are no interventions assigned to either cohort.
|
Outcome Measures
Primary Outcome Measures
- Overall body surface area affected by Atopic Dermatitis (%BSA-AD, single score, scored 0-100) [Baseline to 2 years]
A simple measure of percent body surface area (BSA) involved with AD that complements the Investigator Global Assessment (IGA) in providing a relatively quick accurate representation of disease extent and severity.
- Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM, scored 0-4; clear, almost clear, mild, moderate, and severe) [Baseline to 2 years]
A validated a 5-point IGA scale including morphologic descriptions, ranging from 0 (clear) to 4 (severe).
- Eczema Area and Severity Index (EASI, scored 0-72) [Baseline to 2 years]
EASI is a validated, clinician-assessed scoring system that grades the physical signs of atopic dermatitis/eczema.
- Dermatology Life Quality Index (DLQI, 10 items, scored 0-30) [Baseline to 2 years]
The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week.
- Patient-Oriented Eczema Measure (POEM; 7 items, scored 0-28) [Baseline to 2 years]
POEM asks about the frequency of seven symptoms (itch, sleep disturbance, dryness, flaking, weeping or oozing, bleeding and cracking) in the past seven days.
- Peak Pruritus Numerical Rating Scale (NRS; single item, scored 0-10) [Baseline to 2 years]
The Peak Pruritus NRS is a single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours based on the following question: 'On a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable", how would you rate your itch at the worst moment during the previous 24 hours?'
- Skin Pain NRS (single item, scored 0-10) [Baseline to 2 years]
The Skin Pain NRS is a single self-reported item designed to measure skin pain over the previous 24 hours based on the following question: 'On a scale of 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable", how would you rate your itch at the worst moment during the previous 24 hours?'
- Recap of Atopic Eczema (RECAP; 7 items, scored 0-28) [Baseline to 2 years]
RECAP is a patient- or caregiver-reported instrument to capture 'an individual's experience of eczema control' designed to capture the experience of eczema control in all ages and eczema severities and intended for use in clinical trials and routine care.
- Work Productivity and Activity Impairment-Atopic Dermatitis questionnaire (WPAI-AD v2; 6 items) [Baseline to 2 years]
The questionnaire has four domains: (i) Work Time Missed (absenteeism); (ii) Percent Impairment While Working (presenteeism); (iii) Percent Overall Work Impairment; and (iv) Percent Activity Impairment. Only one domain (Percent Activity Impairment) is completed by patients who are not currently employed.
- EuroQoL 5-dimension (EQ-5D; 5 items and a single VAS) [Baseline to 2 years]
The EQ-5D descriptive system is a preference-based health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult (defined as the age of majority in their state of residence or older) at enrollment
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Able to read and communicate in English
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Willing and able to provide informed consent
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Willing to participate in the collection of patient-reported outcomes for up to 2 years
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For patient Cohort 1: diagnosed with clinically-confirmed AD that is mild-to-moderate (i.e., consistent with a investigator global assessment of 2 or 3) in the judgement of the treating physician
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For patient Cohort 2: diagnosed with clinically-confirmed moderate-to-severe AD and newly initiating an advanced systemic therapy for AD
Exclusion Criteria:
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Current (or planned) participation in an interventional clinical trial where treatment and/or management of AD is being dictated by a protocol
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Patient is not expected to be actively followed (i.e., seen every 6 to 12 months as part of routine care) at the site for AD
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OM1 | Boston | Massachusetts | United States | 02116 |
Sponsors and Collaborators
- OM1, Inc.
- American Academy of Dermatology
Investigators
- Principal Investigator: Gary Curhan, MD, ScD, OM1, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OM1-AD-001