Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism (SmaPE)

Navy General Hospital, Beijing

Status: Not yet enrolling

Conditions: Venous Thromboembolism; Digital Health; Pulmonary Thromboembolisms

Treatments: Other: mobile venous thromboembolism application (mVTEA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06382038

HZKY-PJ-2024-19

Details and patient eligibility

About

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 pulmonary thromboembolism (PTE) on the long-term outcome of PTE patients, in order to enhance clinical practice and establish a foundation of evidence for managing patients with PTE.

Enrollment: 2,972 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inpatients aged ≥18 years;
• （2）PTE confirmed through imaging examinations, meeting at least one of the following criteria: a.Newly diagnosed PTE during the current hospitalization; b. Prior PTE with imaging evidence of residual thrombus.
• Signed informed consent.

Exclusion criteria

• Previous PTE combined with CTEPH;
• Mental retardation or a combination of other serious illnesses that make them incapable of living on their own;
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,972 participants in 2 patient groups

mVTEA Management Group

Experimental group

Description:

Patients randomly assigned to the mVTEA management group will be discharged with mVTEA-assisted patient-centered PTE management.

Treatment:

Other: mobile venous thromboembolism application (mVTEA)

Routine Management Group

No Intervention group

Description:

Patients randomly assigned to the routine management group will be given routine post-discharge management in accordance with local clinical practice.