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临床试验/NCT06350344
NCT06350344尚未招募不适用

Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Multicenter Cohort Study

Navy General Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 2,353 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,353
试验地点
1
主要终点
VTE-related composite event

研究概览

简要总结

Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.

The objective of this study is to observe the long-term effect of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on thromboprophylaxis, and establish a foundation of evidence for managing patients with high-risk VTE.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Inpatients ≥18 years of age at admission;
  • At high-risk of VTE at discharge: Padua score ≥4 for medical patients and Caprini score ≥5 for surgical patients;
  • Signed informed consent.

排除标准

  • Diagnosis of VTE at discharge;
  • Mental disorder or combination of other serious diseases leading to incapacity for independent living;
  • Inability to use smartphones, computer tablets and other smart devices;
  • Being pregnant or breastfeeding;
  • Have participated in similar trials or are undergoing other clinical trials.

结局指标

主要结局

VTE-related composite event

时间窗: At 1-year follow-up

The primary outcome was the occurrence of VTE-related composite event at 1-year follow-up, which was defined as a composite of VTE, major bleeding, VTE-related hospitalization, and all-cause death.

次要结局

  • VTE-KAP questionnaire score(At 3, 12, and 24-month follow-up)
  • Generic quality of life(At 3, 12, and 24-month follow-up)
  • New-onset of atrial fibrillation or atrial flutter(At 3, 6, 12, and 24-month follow-up)
  • Major bleeding(At 3, 6, 12, and 24-month follow-up)
  • Death(At 3, 6, 12, and 24-month follow-up)
  • VTE events(At 3, 6, 12, and 24-month follow-up)
  • VTE-related hospitalization(At 3, 6, 12, and 24-month follow-up)

研究者

发起方
Navy General Hospital, Beijing
申办方类型
Other
责任方
Sponsor

研究点 (1)

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