The Impact of Disease Modifying Therapies (DMTs) and Associated Support Services on Patient Reported Experience Measures (PREMs) and Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 545
- 试验地点
- 1
- 主要终点
- Treatment Satisfaction
研究概览
简要总结
The objective is to establish the impact of current disease modifying therapies (DMTs) and associated support services on Patient Reported Experience Measures and Patient Reported Outcomes in relation to the treatment and management of Relapsing Multiple Sclerosis in the United Kingdom (UK).
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
- •Relapsing Multiple Sclerosis patients aged 18 years or over.
- •Naive to previous DMT therapy and not yet started treatment with a disease modifying therapy.
排除标准
- •Participating in an MS-related clinical trial.
- •Unwilling to provide electronic online consent.
- •Any disability that may impair them from being able to complete the online questionnaire.
- •Do not have regular access to the Internet.
- •Unable to complete the baseline questionnaire before they receive their first DMT injection.
研究组 & 干预措施
Rebif cohort
Subject will receive Rebif as the treatment medication as per the standard or current practices or as directed by the healthcare professional. Allocation of subjects to a specific cohort was based on the first DMT they will be prescribed regardless of any subsequent treatment switches.
干预措施: Rebif (Drug)
结局指标
主要结局
Treatment Satisfaction
时间窗: 96 weeks
The survey sample size has been calculated based on the TSQM-9 questionnaire in order to compare scores between both patient cohorts.
次要结局
- Device satisfaction(96 weeks)
- Evaluation of support services(96 weeks)
- Work Productivity(96 weeks)
- Health Related Quality of Life(96 weeks)
- Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire(96 weeks)