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临床试验/NCT03370523
NCT03370523Unknown不适用

Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2018年7月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5,000
试验地点
1
主要终点
Prevalence of polypharmacy

研究概览

简要总结

As the proportion of elderly population increasing over the last years, polypharmacy and drug-drug interactions (DDI) has been a common health care problem. This study will be performed to find out to prevalence of polypharmacy, inappropriate drug use and DDIs in in elderly patients presenting to a outpatient cardiology clinics.

详细描述

Objective:

As the proportion of elderly population increasing over the last years, polypharmacy and drug-drug interactions (DDI) has been a common health care problem. However, very limited epidemiologic data are available describing polypharmacy, potentially DDIs, and potentially inappropriate medications and their consequences in elderly Turkish patients. Therefore, this study will be performed to find out to prevalence of polypharmacy, inappropriate drug use and DDIs in elderly patients presenting to a outpatient cardiology clinics.

Methods:

The EPIC (Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study will be the first large-scale, observational, real-world multicenter study to evaluate DDIs ve polypharmacy in elderly cardiac outpatients conducted in Turkey. We will enroll all consecutive patients (aged≥ 65 years) admitted to the outpatient cardiology clinics from January 30, 2018, through June 30, 2018, provided written informed consent. Approximately 5000 patients will be enrolled in this non-interventional study. All the data will be collected at one point in time and current clinical practice will be evaluated.

Results:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • All consecutive patients with aged ≥ 65 years

排除标准

  • Patients under 65 years of age
  • Patients who do not want to participate in our study

结局指标

主要结局

Prevalence of polypharmacy

时间窗: 6 months

Polypharmacy will be defined as being on five or more medications at one time.

Severity of comorbid diseases

时间窗: 6 months

The severity of comorbid diseases will be recorded and scored according to Charlson comorbidity index (CCI) and patients will be divided into three groups: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.

Drug-drug interactions

时间窗: 6 months

DDIs will be checked with Lexicomp®. Severe drug interactions will be defined with category D or X DIs.

Prevalence of inappropriate medications

时间窗: 6 months

Potentially inappropriate medications will be defined with 2015 update of Beers criteria.

次要结局

未报告次要终点

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

EDA ÖZLEK

Faculty of Medicine, Department of Cardiology, M.D., Principal Investigator

Muğla Sıtkı Koçman University

研究点 (1)

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