NCT01436838已完成不适用
Prospective Study of Betaferon in Adherence, Coping and Nurse Support in Patients of Chinese Origin With Multiple Sclerosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 110
- 主要终点
- Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment
研究概览
简要总结
Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy thereby involving safety risks for the patient and influencing health cost-effectiveness. This observational study will concentrate upon the role of MS nurses in influencing adherence. This study will examine the influence of initial and subsequent periodic nurse interviews which aim to improve adherence to Betaferon® treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing-remitting multiple scelrosis (RRMS) and secondary progressive multiple sclerosis (SPMS) patients
- •Having Betaferon treatment, including patients who are
- •First time using; or
- •Re-staring; or
- •Switching from other diseases modifying drugs (DMDs)
排除标准
- •Known or newly identified contraindication for administration of Betaferon according to Summary of Product Characteristic (SmPC).
研究组 & 干预措施
Group 1
干预措施: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment
时间窗: at 6, 12, 18 and 24 months
次要结局
- Ways of Coping Questionnaire (WCQ)(at 6, 12, 18 and 24 months)
- Hospital Anxiety and Depression Scale (HAD)(at 6, 12, 18 and 24 months)
研究者
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