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临床试验/NCT02371772
NCT02371772已完成不适用

Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment

Una Ørvim Sølvik0 个研究点目标入组 23 人开始时间: 2008年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
主要终点
Change in Time in therapeutic range (TTR)

研究概览

简要总结

The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.

详细描述

Patients (n=23) on anticoagulant treatment with warfarin participated in a 27 weeks training program where they learned how to analyse International Normalised Ratio (INR) using the point-of-care instrument CoaguChek® XS and dose warfarin. The patients had to display their skills through a test before considered self-managing. They continued to measure INR weekly for 28 weeks. All INR values during the training program and self-control period were collected. In addition, the patients were told to notify if they had any complications during this period. Ten INR values and complications before enrolment was collected from INR cards and/or their general practioner. The participant filled in a quality of life-questioner at enrolment and after 28 weeks of self-management.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •on life-long oral anticoagulation therapy
  • •Live in Bergen municipality
  • •Judged to be qualified for patient self-management anticoagulation treatment by their GP
  • •Motivated to follow the training program

排除标准

  • •Drug abuse
  • •Liver disease

研究组 & 干预措施

Self-management anticoagulation treatment

Other

Trained to monitor INR and dose warfarin

干预措施: Training (Other)

Conventional anticoagulation treatment

No Intervention

Before enrolment

结局指标

主要结局

Change in Time in therapeutic range (TTR)

时间窗: From 39 weeks before enrolment until 28 weeks of self management

次要结局

  • Change in number of complications(From 39 weeks before enrolment until 28 weeks of self management)

研究者

发起方
Una Ørvim Sølvik
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Una Ørvim Sølvik

Associate professor

University of Bergen

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