Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 329
- 主要终点
- Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment
研究概览
简要总结
This is an open-label, prospective post marketing surveillance study to be performed in Sweden. Only data of patients idiopathic PD should be documented, in whom the treating physician plans to initiate a pharmacotherapy with PPX ER independent of this observational study. The questionnaires (Morisky Medication Adherence Measure, patient preference scale, CGI-I, PGI-I) will be used to document routine care in a standardized way and thus ensure high validity of the observational data. As the degree medication adherence of patients is routinely evaluated by their physicians, as is patient preference and possible symptom improvement after initiation of a new therapy, the patient questionnaires will be used to standardise medical routine care and to ensure validity of observational data.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patient with parkinsons disease
干预措施: Pramipexole Extended Release (Drug)
结局指标
主要结局
Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment
时间窗: 8-12 weeks
Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.
Level of Adherence
时间窗: 8-12 weeks
Points on Morisky scale
次要结局
- Patient Preference(8-12 weeks)
- Adverse Events (AE) Considered Related to Observed Medication(8-12 weeks)
- Pramipexole (PPX) Dose(pre-treatment and after 8-12 weeks)
- Clinical Global Impressions (CGI)(8-12 weeks)
- Patients Global Impressions (PGI)(8-12 weeks)
