NCT00240006已完成4 期
An Open Label, Prospective Parallel Cohort Study Comparing A 90-day Copaxone® Adherence Enhancement Program Among Persons With Multiple Sclerosis Who Participate in Shared Solutions® Alone or in Partnership With Their MS Center
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 307
- 主要终点
- Adherence rate of Copaxone therapy by procedural intervention
研究概览
简要总结
To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample of MS patients who are at high risk of nonadherence and receive support from Shared Solutions® and their MS Center versus those who receive support only from Shared Solutions®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Males or females, 18 years of age or older.
- •Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted).
- •Beginning or restarting therapy with Glatiramer Acetate (Copaxone®).
- •Willing and able to complete all procedures and evaluations related to the study.
- •Willing to provide informed consent.
排除标准
- •Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®.
- •Has a significant medical illness other than MS that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
- •Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.
- •Pregnant or trying to become pregnant, or breast feeding during the study.
- •Previously participated in this study or another clinical research study in the past 30 days.
结局指标
主要结局
Adherence rate of Copaxone therapy by procedural intervention
时间窗: 90 days
次要结局
- Compliance of treatment, positive experience of treatment, levels of depression, proportion of time spent, self injection competency ratings, and the risk of non-adherence/non-compliance(90 days)
研究者
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