Studying the Impact of a Medication Use Evaluation by the Community Pharmacist (SIMENON)
2019年7月23日 更新者：Joke Wuyts
In this intervention study, 75 Belgian community pharmacies each recruit 12 patients for an intermediate medication review.
For each patient, the identified drug-related problems and subsequent interventions are registered using the PharmDisc classification.
In a subset of Dutch speaking patients, a pretest-posttest single group design is used to measure the impact of this review on patient related outcomes using questionnaires.
The primary outcome is the medication related quality of life, measured via the living with medicines questionnaire.
Other patient reported outcomes include adherence, self-management, patient satisfaction, fall incidents and use of emergency healthcare services.
Medication records are also collected to objectively measure adherence before and after the intervention.
研究概览
研究类型
介入性
注册 (实际的)
453
阶段
- 不适用
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
70年 及以上 (年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients should be 70 years or older
- Use five or more drugs on a regular basis (prescription or non-prescription drugs)
- Live in the ambulatory setting
- Obtain his medication from this pharmacy on a regular basis
Exclusion Criteria:
-
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
- 主要用途：卫生服务研究
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention group: Frenchspeaking patients
Intervention: Medication review
|
The intervention consists of a medicines use review provided by community pharmacists in Belgium.
A medicines use review is a medication review type 2a in which both a patient interview and dispensing data are used as information sources to identify drug-related problems with a specific focus on the medicines use of the patient.
其他名称：
|
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实验性的：Intervention group: Dutchspeaking patients
Intervention: Medication review Intervention: Dutchspeaking patients are also invited to participate to Additional data collection: questionnaires
|
The intervention consists of a medicines use review provided by community pharmacists in Belgium.
A medicines use review is a medication review type 2a in which both a patient interview and dispensing data are used as information sources to identify drug-related problems with a specific focus on the medicines use of the patient.
其他名称：
Pre-post study design. At three timepoints, data is collected:
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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 |
|---|---|---|
|
Drug-related problems & interventions
大体时间：One timeframe: during the medication review
|
Using the validated PharmDisc classification tool
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One timeframe: during the medication review
|
|
Change in medication related quality of life
大体时间：Three timepoints: Before the review, during review (week 3), after the review (week 12)
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using the Living with medicines questionnaire
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Three timepoints: Before the review, during review (week 3), after the review (week 12)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in adherence
大体时间：9 months before and after the intervention
|
using dispensing data
|
9 months before and after the intervention
|
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Change in adherence
大体时间：Two timepoints: Before the review, after the review (week 12)
|
using the PROMAS questionnaire
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Two timepoints: Before the review, after the review (week 12)
|
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Change in self-management
大体时间：Two timepoints: Before the review, after the review (week 12)
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using the PAM questionnaire
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Two timepoints: Before the review, after the review (week 12)
|
|
Change in use of emergency healthcare services & fall incidents
大体时间：Two timepoints: Before the review, after the review (week 12)
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using own questions
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Two timepoints: Before the review, after the review (week 12)
|
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Satisfaction with the new service
大体时间：One timepoint: during the review (week 3)
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Using the PSPSQ2 questionnaire
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One timepoint: during the review (week 3)
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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。
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 (实际的)
2016年11月8日
初级完成 (实际的)
2017年10月11日
研究完成 (实际的)
2018年10月30日
研究注册日期
首次提交
2017年6月1日
首先提交符合 QC 标准的
2017年6月6日
首次发布 (实际的)
2017年6月7日
研究记录更新
最后更新发布 (实际的)
2019年7月24日
上次提交的符合 QC 标准的更新
2019年7月23日
最后验证
2019年7月1日
更多信息
与本研究相关的术语
其他研究编号
- SIMENONv3
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Medication review的临床试验
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and Infectious Diseases...完全的