Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease
2014年3月14日 更新者：Boehringer Ingelheim
Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease
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.
研究概览
研究类型
观察性的
注册 (实际的)
329
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
specialist care
描述
Inclusion criteria:
- Patients suffering from idiopathic PD who before inclusion into the observation had been planned to be treated with PPX ER according to the SP, and where decision of treatment was made independently of the patients¿ inclusion into this observational study
- Stable dose of PPX IR for at least 4 weeks before inclusion into the observation
- Male or female PD patients aged at least 30
- Ability to reliably complete self-rating scales (Morisky Medication Adherence Measure, patient preference scale) according to the physician¿s judgement
- Written informed consent by the patient for study participation.
Exclusion criteria:
- Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems) according to the physician¿s judgement.
- Any contraindications against PPX ER according to the Summary of Product Characteristics (SPC).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patient with parkinsons disease
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment
大体时间：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.
|
8-12 weeks
|
|
Level of Adherence
大体时间：8-12 weeks
|
Points on Morisky scale
|
8-12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Preference
大体时间：8-12 weeks
|
Patients were asked about their preference regarding frequency of intake (once daily or three times daily)
|
8-12 weeks
|
|
Adverse Events (AE) Considered Related to Observed Medication
大体时间：8-12 weeks
|
Some patients had not related AEs as well as related AEs.
|
8-12 weeks
|
|
Pramipexole (PPX) Dose
大体时间：pre-treatment and after 8-12 weeks
|
mean Pramipexole (PPX) dose
|
pre-treatment and after 8-12 weeks
|
|
Clinical Global Impressions (CGI)
大体时间：8-12 weeks
|
Clinical Global Impression (CGI) scale at final visit
|
8-12 weeks
|
|
Patients Global Impressions (PGI)
大体时间：8-12 weeks
|
Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation.
|
8-12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年3月1日
初级完成 (实际的)
2011年9月1日
研究注册日期
首次提交
2010年3月25日
首先提交符合 QC 标准的
2010年3月31日
首次发布 (估计)
2010年4月1日
研究记录更新
最后更新发布 (估计)
2014年4月11日
上次提交的符合 QC 标准的更新
2014年3月14日
最后验证
2014年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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