Smart Technology Facilitated Patient-centered Venous Thromboembolism Management (SmaVTE-COR)

April 9, 2024 updated by: Navy General Hospital, Beijing

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2353

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ZHI-GENG JIN, Doctor
  • Phone Number: 8615801402223
  • Email: lwgjzg@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100048
        • Sixth Medical Center of Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mVTEA Management Group
Patients with high-risk of VTE will be discharged with mVTEA-assisted patient-centered VTE management.
Device: mobile venous thromboembolism application (mVTEA)
mVTEA will assist in the management of patients with high-risk of VTE during the post-hospitalization follow-up phase. The mVTEA's doctor terminal automatically sends VTE-related health education materials in different frequencies and contents based on the patient's knowledge of VTE prevention and treatment, as well as their risk of thrombosis and bleeding during follow-up. In addition, thrombosis physicians on the mVTEA's doctor terminal can deliver health education to patients based on their condition. This can be done through the mVTEA doctor-patient communication module, which includes text, voice, and video communication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 1-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VTE events
Time Frame: At 3, 6, 12, and 24-month follow-up

VTE events will be documented during the follow-up. VTE events are categorized into two groups: new-onset VTE, and hospital-acquired VTE (HA-VTE).

VTE that occurred for the first time during the study period, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is classified as new-onset VTE.

HA-VTE is defined as any new-onset VTE that has occurred within 90 days of hospital discharge.
At 3, 6, 12, and 24-month follow-up
Major bleeding
Time Frame: At 3, 6, 12, and 24-month follow-up
The major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH) will be documented during the follow-up.
At 3, 6, 12, and 24-month follow-up
VTE-related hospitalization
Time Frame: At 3, 6, 12, and 24-month follow-up
Hospitalization due to the new-onset DVT and/or PE will be documented during the follow-up.
At 3, 6, 12, and 24-month follow-up
New-onset of atrial fibrillation or atrial flutter
Time Frame: At 3, 6, 12, and 24-month follow-up
The new-onset of atrial fibrillation or atrial flutter will be documented during the follow-up.
At 3, 6, 12, and 24-month follow-up
Death
Time Frame: At 3, 6, 12, and 24-month follow-up
Death will be documented during the follow-up. It is categorized into all-cause death and PE-related death. All-cause death is defined as death that occurs during the study period, regardless of cause.PE-related death is defined as death that is unequivocally due to PE.
At 3, 6, 12, and 24-month follow-up
VTE-KAP questionnaire score
Time Frame: At 3, 12, and 24-month follow-up
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 54 questions with an overall score range of 49 to 291. The higher the score, the higher the level of knowledge, attitude, and practice. The VTE-KAP questionnaire scores of the patients regarding the prevention and treatment of VTE will be evaluated at 3, 12, and 24-month follow-up.
At 3, 12, and 24-month follow-up
Generic quality of life
Time Frame: At 3, 12, and 24-month follow-up
Generic, non-disease-specific health-related quality of life (QoL) is assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire and its corresponding visual analogue scale at 3, 12, and 24-month follow-up. Briefly, the EQ-5D-5L generates an overall index that ranges from 0 (lowest generic QoL) to 1 (highest generic QoL) and is calculated based on country-specific reference value sets. The EQ-5D-5L health index was calculated with the value set for China. The EuroQol visual analogue scale ranges from 0 to 100, with higher scores indicating better health.
At 3, 12, and 24-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Investigators

  • Study Chair: YU-TAO GUO, Doctor, Sixth Medical Center of Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZKY-PJ-2024-8-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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