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Clinical Trials/NCT06350344
NCT06350344
Not yet recruiting
Not Applicable

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

Navy General Hospital, Beijing1 site in 1 country2,353 target enrollmentNovember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous Thromboembolism
Sponsor
Navy General Hospital, Beijing
Enrollment
2353
Locations
1
Primary Endpoint
VTE-related composite event
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
October 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Navy General Hospital, Beijing
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

VTE-related composite event

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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