NCT00787657已完成不适用
Betaferon Prospective Study on Adherence, Coping and Nursing Support
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,723
- 主要终点
- Proportion of patients adhering to treatment
研究概览
简要总结
- The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
- The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after first clinical event suggestive of multiple Sclerosis (MS) (according to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis.
排除标准
- •Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)
研究组 & 干预措施
Arm 1
干预措施: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
Proportion of patients adhering to treatment
时间窗: 6, 12, 18 and 24 months
次要结局
- WCQ (Ways of Coping Questionnaire)(6, 12, 18 and 24 months)
- RODQ (Risk of Dropout Questionnaire)(Monthly over 6 months; every other month thereafter)
- Rate of study dropout(6, 12, 18 and 24 months)
- HADS (Hospital Anxiety and Depression Scale)(6, 12, 18 and 24 months)
- Relapse rate(6, 12, 18 and 24 months)
- Rate of early treatment termination(6, 12, 18 and 24 months)
- Predictive value of BL parameters, WCQ, HADS, RODQ(12 and 24 months)
- EDSS (Expanded Disability Status Scale)(6, 12, 18 and 24 months)
研究者
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