跳至主要内容
临床试验/NCT04907305
NCT04907305终止不适用

Next-Gen MS: A Prospective, Cluster-randomized Study Evaluating the Impact of "Feed-forward" Patient Reported Outcomes Data to Clinical Teams Managing Adults Living With MS in a Learning Health System for MS Research

EMD Serono Research & Development Institute, Inc.8 个研究点 分布在 1 个国家目标入组 1,594 人开始时间: 2021年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1,594
试验地点
8
主要终点
Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14)

研究概览

简要总结

This Next Generation learning health system for Multiple Sclerosis (Next-Gen MS) study is a sub-study of the MS-LINK™ Outcomes Study (NCT04735406). The study aims to examine the effects of using feed forward Patient Reported Outcomes (PROs) data in real-world Multiple Sclerosis (MS) care settings. The study will be conducted within an emerging Learning Healthcare System (LHS).

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

入选标准

  • Participants willing and able to provide written informed consent
  • Participants with clinical diagnosis of Multiple Sclerosis (MS)

排除标准

  • 未提供

结局指标

主要结局

Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14)

时间窗: Baseline up to 18 Months

次要结局

  • Percentage of Participants with >=1-point Increase from Baseline in Patient Determined Disease Steps (PDDS) Sustained Via Consecutive Measures Over 3 Months(Baseline up to 18 Months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (8)

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