ClinPRO-DERM: A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- OM1, Inc.
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Overall body surface area involvement (%BSA-AD, single score, scored 0-100)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Overall body surface area involvement (%BSA-AD, single score, scored 0-100)
时间窗: Baseline to 2 years
A simple measure of percent body surface area involved that complements the IGA in providing a relatively quick accurate representation of disease extent and severity.
Investigator Global Assessment (IGA, scored 0-4; clear, almost clear, mild, moderate, and severe).
时间窗: Baseline to 2 years
A 5-point IGA scale including morphologic descriptions, ranging from 0 (clear) to 4 (severe).
EuroQoL 5-dimension (EQ-5D; 5 items and a single VAS)
时间窗: Baseline to 2 years
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Dermatology Life Quality Index (DLQI, 10 items, scored 0-30)
时间窗: 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
Work Productivity and Activity Impairment questionnaire (WPAI,-GH v2.0, 6 items)
时间窗: Baseline to 2 years
The questionnaire has four domains: Work Time Missed; Percent Impairment While Working; Percent Overall Work Impairment; and Percent Activity Impairment. Only one domain (Percent Activity Impairment) is completed by patients who are not currently employed
Patient Health Questionnaire-2 (PHQ-2, 2 items)
时间窗: Baseline to 2 years
A simple two-item questionnaire evaluating the degree to which an individual has experienced depressed mood and anhedonia over the past two weeks. This survey is intended to screen for potential depression and is not diagnostic
次要结局
未报告次要终点