A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions

NCT ID: NCT05084417

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-09
• Study Completion Date: 2026-01-15

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

Conditions

Atopic Dermatitis; Dermatology; Vitiligo; Alopecia Areata; Hidradenitis Suppurativa; Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1: Alopecia Areata

Cohort 1 is limited to patients clinically diagnosed with Alopecia Areata. Patients in this cohort will receive the universal ClinROs and PROs (i.e. not disease specific) as well as additional AA-specific measures throughout the length of the study.

N/A This is an observational study

Intervention Type: OTHER

As this is an observational study, there are no interventions assigned to either cohort.

Cohort 2: Atopic Dermatitis

Cohort 2 is comprised of patients that have been clinically diagnosed with Atopic Dermatitis. Patients in this cohort will receive the universal PROs and ClinROs, but will also receive additional AD-specific measures throughout the length of the study.

N/A This is an observational study

Intervention Type: OTHER

As this is an observational study, there are no interventions assigned to either cohort.

Cohort 3: Hidradenitis Suppurativa

Cohort 3 is limited to patients clinically diagnosed with Hidradenitis Suppurativa. Patients in this cohort will receive the universal ClinROs and PROs (i.e. not disease specific) as well as additional HS-specific measures throughout the length of the study.

N/A This is an observational study

Intervention Type: OTHER

As this is an observational study, there are no interventions assigned to either cohort.

Cohort 4: Psoriasis

Cohort 4 is limited to patients clinically diagnosed with Psoriasis. Patients in this cohort will receive the universal ClinROs and PROs (i.e. not disease specific) as well as additional PsO-specific measures throughout the length of the study.

N/A This is an observational study

Intervention Type: OTHER

As this is an observational study, there are no interventions assigned to either cohort.

Cohort 5: Vitiligo

Cohort 5 is limited to patients clinically diagnosed with Vitiligo. Patients in this cohort will receive the universal ClinROs and PROs (i.e. not disease specific) as well as additional VL-specific measures throughout the length of the study.

N/A This is an observational study

Intervention Type: OTHER

As this is an observational study, there are no interventions assigned to either cohort.

Interventions

N/A This is an observational study

As this is an observational study, there are no interventions assigned to either cohort.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Dermatology

UNKNOWN

Sponsor Role: collaborator

OM1, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

OM1, Inc.

Locations

OM1

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

OM1-DERM-001

Identifier Type: -

Identifier Source: org_study_id