Smart Technology Facilitated Patient-centered Venous Thromboembolism Management

Not Applicable

Not yet recruiting

• Conditions: Health Education; Digital Health; Venous Thromboembolism
• Interventions: Device: mobile venous thromboembolism application (mVTEA)

• Registration Number: NCT06350344
• Lead Sponsor: Navy General Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-31
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Study Start: 2024-11-01
• Primary Completion: 2026-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2353

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mVTEA Management Group	mobile venous thromboembolism application (mVTEA)	Patients with high-risk of VTE will be discharged with mVTEA-assisted patient-centered VTE management.

Primary Outcome Measures

Name	Time	Method
VTE-related composite event	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 Outcome Measures

Name	Time	Method
VTE-KAP questionnaire score	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 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 of the patients regarding the prevention and treatment of VTE will be evaluated at 3, 12, and 24-month follow-up.
Generic quality of life	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.
New-onset of atrial fibrillation or atrial flutter	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.
Major bleeding	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.
Death	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.
VTE events	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.
VTE-related hospitalization	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.

Trial Locations

Locations (1)

Sixth Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China