The MS-LINK™ Outcomes Study: A Comprehensive Prospective Longitudinal Assessment of Patient and Clinical Reported Outcomes in Multiple Sclerosis Patients Across North America
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,182
- 试验地点
- 9
- 主要终点
- 9-Hole Peg Test (9HPT) Score
研究概览
简要总结
The Multiple Sclerosis (MS) Leadership and Innovation Network (MS-LINK™) is comprised of networks working cooperatively to advance Multiple Sclerosis (MS) science and improve MS participant outcomes. In this study participants will be followed from the time of consent through the lifetime of the study (currently 3 years), unless the participant chooses to withdraw from the study. Collection of participant's medical history, including MS and treatment history, will be automated through extraction from the participant's electronic medical record (EMR) and other health information systems (for example, radiology). Participants will complete patient-reported outcomes (PROs) and other health-related information digitally. Participating participants will have access to their own data in an ongoing manner via a web-based Participant Portal.
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
- •Participants willing and able to provide written informed consent
- •Participants willing to be contacted while participating in the study for recruitment into sub-studies that may be relevant to them
- •Participants willing and able to complete PROs on a monthly basis and document events of interest as they occur
- •Participants willing to participate in additional follow up at the site for at least three years
排除标准
- •Unable to complete questionnaires in English
- •Unable to consistently access the Internet
- •Participants participating in interventional clinical drug trials at baseline
结局指标
主要结局
9-Hole Peg Test (9HPT) Score
时间窗: Baseline up to 3 years
Symbol Digit Modalities Test (SDMT)
时间窗: Baseline up to 3 years
Timed 25-Foot Walk Test
时间窗: Baseline up to 3 years
Wasson Health Confidence Scale Score
时间窗: Baseline up to 3 years
Number of Participants with Current Use of Disease-Modifying Therapies (DMT)
时间窗: Baseline up to 3 years
Expanded Disability Status Scale (EDSS) Score
时间窗: Baseline up to 3 years
Multiple Sclerosis Functional Composite (MSFC) Score
时间窗: Baseline up to 3 years
Number of Participants with History of Fall
时间窗: Baseline up to 3 years
Patient-determined Disease Steps (PDDS) Scale Score
时间窗: Baseline up to 3 years
Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score
时间窗: Baseline up to 3 years
Well-being of Participant Assessed by Physical Activity Diary
时间窗: Baseline up to 3 years
Participants can opt-in to use the Patient Portal to track their well-being in up to 9 domains like Sleep, Mood, Pain, Exercise, Mobility, Wellness, Energy, Bladder Function, Leisure activities.
Number of Participants With Adherence to Treatment as Assessed by Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)
时间窗: Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Fatigue Score
时间窗: Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Physical Function Score
时间窗: Baseline up to 3 years
Patient Health Questionnaire 9-Item (PHQ9) Score
时间窗: Baseline up to 3 years
Occurrence of Relapses
时间窗: Baseline up to 3 years
Occurrence of Multiple Sclerosis (MS) Symptoms
时间窗: Baseline up to 3 years
Number of Utilization of Healthcare Resources by Participants
时间窗: Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score
时间窗: Baseline up to 3 years
Patient Reported Outcomes Measurement Information System (PROMIS) MS Cognitive Function Score
时间窗: Baseline up to 3 years
Health-related Quality of Life Assessed by Centers for Disease Control and Prevention Health-Related Quality of Life Measure (CDC HRQoL-14)
时间窗: Baseline up to 3 years
Number of Participants with Reasons for Discontinued Disease-Modifying Therapies (DMT)
时间窗: Baseline up to 3 years
Duration of Disease-Modifying Therapies (DMT) use
时间窗: Baseline up to 3 years
Number of Participants with Response to Health Priorities and Goals
时间窗: Baseline up to 3 years
Responses of participants regarding concern of Multiple Sclerosis (MS) for next visit, priority and wellness goals, and how close they are completing the goal will be recorded.
Paced Auditory Serial Addition Test (PASAT) Score
时间窗: Baseline up to 3 years
Processing Speed Test (PST)
时间窗: Baseline up to 3 years
Number of Participants with Magnetic resonance imaging (MRI) History
时间窗: Baseline up to 3 years
Number of Participants with Adverse Events of Interest
时间窗: Baseline up to 3 years
Number of Participants with Symptoms of Coronavirus (COVID)
时间窗: Baseline up to 3 years
次要结局
未报告次要终点