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

NCT ID: NCT06382038

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2972 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-08
• Study Completion Date: 2026-10-31

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 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.

Conditions

Venous Thromboembolism; Pulmonary Thromboembolisms; Digital Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

mVTEA Management Group

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

Group Type: EXPERIMENTAL

mobile venous thromboembolism application (mVTEA)

Intervention Type: OTHER

mVTEA will assist in the management of patients during the post-hospitalization follow-up phase. The mVTEA's doctor terminal automatically sends venous thromboembolism (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.

Routine Management Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mobile venous thromboembolism application (mVTEA)

mVTEA will assist in the management of patients during the post-hospitalization follow-up phase. The mVTEA's doctor terminal automatically sends venous thromboembolism (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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Navy General Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YU-TAO GUO, Doctor

Role: STUDY_CHAIR

Sixth Medical Center of Chinese PLA General Hospital

Locations

Sixth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

ZHI-GENG JIN, Doctor

Role: CONTACT

lwgjzg@163.com

8615801402223

References

Valerio L, Mavromanoli AC, Barco S, Abele C, Becker D, Bruch L, Ewert R, Faehling M, Fistera D, Gerhardt F, Ghofrani HA, Grgic A, Grunig E, Halank M, Held M, Hobohm L, Hoeper MM, Klok FA, Lankeit M, Leuchte HH, Martin N, Mayer E, Meyer FJ, Neurohr C, Opitz C, Schmidt KH, Seyfarth HJ, Wachter R, Wilkens H, Wild PS, Konstantinides SV, Rosenkranz S; FOCUS Investigators. Chronic thromboembolic pulmonary hypertension and impairment after pulmonary embolism: the FOCUS study. Eur Heart J. 2022 Sep 21;43(36):3387-3398. doi: 10.1093/eurheartj/ehac206.

Reference Type: BACKGROUND

PMID: 35484821 (View on PubMed)

Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost. 2010 Jan;8(1):202-4. doi: 10.1111/j.1538-7836.2009.03678.x. Epub 2009 Oct 30.

Reference Type: BACKGROUND

PMID: 19878532 (View on PubMed)

Other Identifiers

HZKY-PJ-2024-19

Identifier Type: -

Identifier Source: org_study_id