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临床试验/NCT06350331
NCT06350331Enrolling By Invitation不适用

Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Randomised Controlled Trial

Navy General Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2024年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
256
试验地点
1
主要终点
VTE-KAP questionnaire score

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 evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with VTE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

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;
  • Previous or current definitive diagnosis of DVT and/or PE by imaging, or 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

  • 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-KAP questionnaire score

时间窗: The third month after discharge from the hospital

The VTE-KAP questionnaire is a self-administered questionnaire that includes demographic characteristics, knowledge, attitude, and practice (KAP) of patients towards VTE prevention and treatment. The VTE-KAP questionnaire consists of a total of 53 questions with an overall score range of 41 to 283. The higher the score, the higher the level of knowledge, attitude, and practice. The VTE-KAP questionnaire scores will be evaluated at the third-month follow-up after discharge.

次要结局

  • Post-pulmonary embolism syndrome (PPES)(The third month after discharge)
  • VTE events(3 months after discharge)
  • Chronic thromboembolic pulmonary hypertension (CTEPH)(The third month after discharge)
  • Knowledge, attitude, and practice scores in the VTE-KAP questionnaire(The third month after discharge from the hospital)
  • Chronic thromboembolic pulmonary disease (CTEPD)(The third month after discharge)
  • New-onset of atrial fibrillation or atrial flutter(3 months after discharge)
  • Major bleeding(3 months after discharge)
  • Generic quality of life(The third month after discharge from the hospital)
  • VTE-related hospitalization(3 months after discharge)
  • VTE-related rehospitalization(3 months after discharge)
  • Death(3 months after discharge)

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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