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临床试验/NCT03154489
NCT03154489已完成不适用

Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care

Universidad San Jorge2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2017年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
204
试验地点
2
主要终点
Effectiveness of medication review with follow-up

研究概览

简要总结

The interdisciplinary collaboration between doctors, nurses and pharmacists, can facilitate the control of patients under treatment with coumarin anticoagulants, increasing their safety and effectiveness. On the other hand, the clinical utility of tools such as pharmacogenetics and the SAME-TT2R2 is unexplored. Based on the foregoing, it seems necessary to study the impact of the Program of medication review with follow-up in collaboration with doctors and nurses in primary care improves the degree of control of the patients under treatment with coumarin anticoagulants. Method: a randomized, controlled study for the main objective. Population and scope of study: Patients on treatment with coumarin anticoagulants with time in therapeutic range (TTR) according to the method of Rosendaal less than 70% in follow-up from primary care in a health area of the Arrabal Health Center (Zaragoza, Spain). Each patient will be followed by a period of 6 months. After this period, patients in the control group (CG) will receive the service of medication review with follow-up for a period of time equivalent (6 months). Intervention: Program of pharmacotherapy follow-up. Variables result: Stability of the INR, drug adherence, intake of vitamin K, knowledge of the patient on the use of acenocoumarol, associated costs, avoided costs, quality of life, satisfaction of patients and professionals involved. Statistical analysis and sample size: 204 patients. Multivariate analysis will be used and cost-effectiveness..

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Investigator)

入排标准

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

入选标准

  • Submit a TTR less than 70% in the last 6 months.

排除标准

  • Not sign the informed consent.
  • Present cognitive difficulties for the project.

结局指标

主要结局

Effectiveness of medication review with follow-up

时间窗: 6 months

Compare the effectiveness of medication review with follow-up in collaboration with doctors and nurses of primary care patients in treatment with anticoagulants coumarins against the usual practice used actually. Principally studying INR control of this patients during 6 months.

次要结局

  • Quality of life related to health(6 months)
  • Study of patients habits(6 months)
  • Pharmacogenetic analysis of genes CYP2C9 and VKORC1, ApoE CYP4F2 in each patient(6 months)
  • Satisfaction in primary care professionals(6 months)
  • Review of clinical guidelines used in primary care(6 months)
  • Economic outcomes(6 months)

研究者

发起方
Universidad San Jorge
申办方类型
Other
责任方
Sponsor

研究点 (2)

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