Comparison Between Conventional Anticoagulation Treatment and Self-management of Anticoagulation Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 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=132) on anticoagulant treatment with warfarin participated in a 21 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 two years. 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. INR values and complications two years 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 two years of self-management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •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
结局指标
主要结局
Change in Time in therapeutic range (TTR)
时间窗: From two years before enrolment until two years of self management
Change in TTR from conventional treatment to self-management
次要结局
- Change in number of complications(From two years before enrolment until two years of self management)
- Quality of life (QoL)(Baseline before training and after two years with self-management)
研究者
Una Ørvim Sølvik
Associate Professor
University of Bergen