Factors That Influence Compliance With Disease-Modifying Therapy in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,040
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the coorelation between patient factors, health care provider factors, drug factors and compliance in patients with relapsing forms of multiple sclerosis (RMS) treated with Disease Modifying Agents (DMA). We hypothesize that a number of factors influence compliance with DMA's.
详细描述
While compliance rates with interferons and glatiramer acetate treatment have been high when assessed in the context of controlled clinical trials, we have observed substantially less consistent rates of drug administration in general practice. Correspondingly, the magnitude of drug efficacy achieved on clinical and surrogate markers of disease activity in the latter patient group may be compromised compared to patients participating in controlled clinical trials. Further, in many circumstances, the perception of breakthrough disease simply constitutes treatment noncompliance.
The National Multiple Sclerosis Society reports only 50% of all MS patients and 60% with relapsing remitting MS are taking disease modifying agents in the U.S. (Zwibel 2003) A number of studies have investigated this challenging issue. When glatiramer acetate therapy was specifically evaluated, the investigators found several factors to be associated with compliance. They discovered adherence to be higher with the patient perception of physician support of the medication prescribed, patient sense of control, higher levels of hope and no previous use of other disease modifying therapy (Fraser, Hadjimichael, and Vollmer 2001). Another study by Hadjimichael and Vollmer (1999) surveyed patients for reasons that medications were discontinued. Disease progression, lack of improvement and side effects were some of the reasons reported by patients for stopping disease-modifying therapy.
Depression is another factor found to impact adherence. Mohr, Goodkin, Likosky, Gatto, Baumann and Rudick (1997) saw increased rates of compliance with Interferon beta-1b therapy in multiple sclerosis with the treatment of underlying depression. The study showed that patients with increased depression were more likely to discontinue therapy. This link of depression has also been demonstrated with noncompliance with antihypertensive medications. (Wang,Bohn, Harooni et al. 2002) In another study, Mohr (2001) saw patient's experienced level of anxiety with their injections was related to adherence.
We hypothesize that a number of factors influence compliance with DMA's, these include:
- Patient factors
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Other
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
- •Diagnosis of relapsing form of multiple sclerosis
- •Age 18 or older
- •Therapy with disease modifying agent (Glatiramer acetate, Interferon Beta-1b, ot Interferon Beta 1a (IM or SC) for at least 6 months
- •Access to the internet to complete the study survey
排除标准
- •Diagnosis of progressive forms of multiple sclerosis
- •Therapy on DMA for less than 6 months
- •Inability to complete the survey
- •Participation in other investigational studies within the last 6 months
