Clinical trial NCT05084417: A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions
Official title: ClinPRO-DERM: A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Atopic Dermatitis
Dermatology
Vitiligo
Alopecia Areata
Hidradenitis Suppurativa
Psoriasis
Keywords: Registry
Patient Outcomes
Dermatological Conditions
Lead sponsor: OM1, Inc.
Sponsor class: INDUSTRY
Collaborators: name: American Academy of Dermatology
First posted: 2021-10-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (defined as at least the age of majority in their state or older) who have received a clinical diagnosis of alopecia areata, atopic dermatitis, hidradenitis suppurativa, psoriasis, or vitiligo.

Brief summary: The primary goal of the study is to collect standardized patient and clinician reported outcome measures for patients diagnosed with a range of dermatological conditions in an academic clinical practice setting. By regularly measuring outcomes longitudinally in patients treated in a real-world setting, this study will provide valuable and necessary information as to the impact of both the disease and its treatments on patients over time and will inform the optimal clinical management of patients with living with dermatological disease.

Detailed description: The study is a multi-center, longitudinal, observational study to describe longitudinal trajectories of Clinician-Reported Outcomes (ClinROs) and Patient-Reported Outcomes (PROs) in patients with select dermatological conditions. This study will collect data using validated clinical instruments and patient-reported data on the disease course of alopecia areata (AA), atopic dermatitis (AD), hidradenitis suppurativa (HS), psoriasis (PsO), and vitiligo (VL), including symptom assessments and quality of life (QoL) measures from a patient perspective, to supplement routine clinical data collected from their healthcare providers. ClinRO data will be collected at baseline and routine follow-up visits for up to two years. PRO data will be collected directly from patients at baseline and at pre-specified follow-up time points (as defined in Tables 1 - 2e) for up to two years.

The objectives of this study are:

* To describe longitudinal changes in disease activity, symptom control and both physical and mental HrQoL based on both ClinROs and PROs
* To identify patient, disease and treatment factors associated with changes in PROs over time
* To describe the association between PROs, ClinROs and clinical outcomes

Eligibility criteria: Inclusion Criteria:

* Adult (defined as the age of majority in their state of residence or older) at enrollment
* Able to read and communicate in English
* Have a smart phone or other internet enabled device capable of PRO data collection
* Diagnosed with a qualifying, clinically confirmed, diagnosis of a study condition in the judgement of the treating physician at presentation
* Willing and able to provide informed consent
* Willing to participate in the collection of patient-reported outcomes for up to two years

Exclusion Criteria:

* Current (or planned) participation in an interventional clinical trial where treatment and/or management of any of the study conditions is being dictated by a protocol.
* Patient is not expected to be actively followed (i.e., seen at least annually as part of routine care) at the site for the duration of the follow-up period.

Primary outcomes:
measure: Overall body surface area involvement (%BSA-AD, single score, scored 0-100)
timeFrame: Baseline to 2 years
measure: Investigator Global Assessment (IGA, scored 0-4; clear, almost clear, mild, moderate, and severe).
timeFrame: Baseline to 2 years
measure: Dermatology Life Quality Index (DLQI, 10 items, scored 0-30)
timeFrame: Baseline to 2 years
measure: Work Productivity and Activity Impairment questionnaire (WPAI,-GH v2.0, 6 items)
timeFrame: Baseline to 2 years
measure: EuroQoL 5-dimension (EQ-5D; 5 items and a single VAS)
timeFrame: Baseline to 2 years
measure: Patient Health Questionnaire-2 (PHQ-2, 2 items)
timeFrame: Baseline to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: OM1
state: Massachusetts
Study officials:
affiliation: OM1, Inc.
name: Stefan Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: