Evaluation of the Impact of Using LabPad® Point-of-care to Measure International Normalized Ratio (INR) at Home on the Patient's Follow up on VKA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Patient follow up time, regardless of the value of the INR
研究概览
简要总结
This study evaluates the impact of using LabPad® point-of-care to measure International Normalized Ratio (INR) at home on the patient's follow up on vitamine K antagonist (VKA) treatment during 6 months.
详细描述
The impact of the LabPad® point-of-care use by the nurse will be evaluated in the patients on vitamine K antagonist (VKA) treatment by measuring the time elapsed between the reading of the International Normalized Ratio (INR) by the LabPad® at patient's home and the validation of the biological measure, The time that the patient spends in his therapeutic range will be measured. The adverse events related to VKA will also be collected. At the end of the study, the patient will complete satisfaction and usage questionnaires about the LabPad®.
This study will be performed for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age
- •Patient treated with VKA and without any heparin - VKA relay
- •Patient able to read and understand the procedure, and able to express consent for the study
排除标准
- •Patient treated with heparin
- •Patient treated with direct oral anticoagulants (DAOs)
- •Patient with antiphospholipid antibody syndrome (APA)
- •Patient not available or wishing to change region within one year of inclusion
- •Patient currently participating or having participated in the month preceding the inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
- •Persons referred to in Articles L.1121-5 to L.1121-8 of the French Public Health Law (corresponds to all protected persons: pregnant woman (verified by the dosage of β- human chorionic gonadotropin for any woman wishing to participate in the protocol and of childbearing age < 60 years), parturient, nursing woman, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)
结局指标
主要结局
Patient follow up time, regardless of the value of the INR
时间窗: During 6 months of use
Measure of time in minute elapsed between the reading of the INR by the LabPad® and the validation of the biological measure, regardless of the value of the INR
次要结局
- Patient follow up time, in case of INR outside the safety interval (≤1,8 or ≥5)(During 6 months of use)
- Time in Therapeutic Range(During 6 months of use)
- Number of adverse events related to VKA(During 6 months of use)
- Patient's satisfaction about the LabPad®: Satisfaction Questionnaire(After 6 months of use)
- LabPad® patient's use(After 6 months of use)