Portuguese BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis (MS) After Conversion to Betaferon by Using Elements of the BetaPlus Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 10
- 主要终点
- Identification of reasons why patients are switched from other disease modifying drugs to Betaferon due to perceived lack of efficacy, adverse events, poor compliance, and others.
研究概览
简要总结
This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ) and depression questionnaire CES-D.
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-remitting MS (RRMS) or secondary-progressive MS (SPMS)
- •Previous treatment with disease modifying drugs
- •Adjustment of disease modifying treatment necessary at the discretion of the investigator
- •Switch to Betaferon at least 1 month but not longer than 3 months prior to inclusion
排除标准
- •Patients not fulfilling the indications in the local prescribing information
- •Refusal to sign inform consent
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
Identification of reasons why patients are switched from other disease modifying drugs to Betaferon due to perceived lack of efficacy, adverse events, poor compliance, and others.
时间窗: After 2 years
Assessment of factors predictive of non-adherence to disease modifying drugs such as demographic data, course of disease, drug history, patients characteristics, history of poor compliance to prior therapy or others.
时间窗: After 2 years
次要结局
- Assessment of impact of supportive elements of the BetaPlus Program like nurse support, auto-injector, website, etc on treatment adherence.(After 2 years)
- Evaluation of impact of Betaferon treatment on health related quality of life using the Functional Assessment of Multiple Sclerosis Questionnaire - FAMS.(After 2 years)
- Assessment of coping processes by applying the Ways of Coping Questionnaire.(After 2 years)
- Measurement of safety of Betaferon by assessing the number of participants with adverse events and severe adverse events. Classification by MedDRA category.(After 2 years)