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临床试验/NCT01339611
NCT01339611Unknown不适用

Education Program for Patients Receiving Oral Anticoagulation

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
Change from Baseline in health-related quality of life at 2 months

研究概览

简要总结

The aim of the study is to test if patients under oral anticoagulation therapy who are going to participate in the education program will have better Health-related quality of life, higher rate in pharmacological treatment adherence and better self efficacy to manage the treatment.

详细描述

Patients who are going to use oral anticoagulant will participate in an individual orientation, using instructional material (slides and illustrative booklet) during hospitalization period. After the discharge 2 phone calls will be done (after: a week and four weeks) focusing on the strategies to improve patient's self-efficacy to manage the oral anticoagulation. There will be a personal contact among researcher and participants when the patients return at the oral anticoagulant ambulatory, two months after the treatment start. At this time the following variables of interest will be evaluated: Health-related quality of life; adherence to treatment and patients' self-efficacy.

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
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

入选标准

  • Patients admitted in two public hospitals, in São Paulo state interior and who are going to start the use of oral anticoagulant during this hospitalization
  • Patients admitted in two public hospitals, in São Paulo state interior and who are going to adjust therapeutically oral anticoagulant dosage or to start over treatment.

排除标准

  • Individuals who do not at all have any ability to understand the data collection instrument questions, measured by the instrument Mental State Mini-exam.
  • Individuals who do not have a telephone to be contacted after hospital discharge;
  • Individuals who are going to metallic valve prosthesis implant surgery in the last six months.

结局指标

主要结局

Change from Baseline in health-related quality of life at 2 months

时间窗: baseline (hospitalization time) and two months after discahrge

the health-related quality of life will be measure by Duke Anticoagulation Satisfaction Scale

次要结局

  • change from baseline in oral anticoagulation treatment adherence at 2 months(baseline (hospitalization time) and two months after discahrge)

研究者

申办方类型
Other

研究点 (2)

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