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

NCT06382038 | Not Yet Recruiting DMC

• 1 other identifier: HZKY-PJ-2024-19
• Study Type: interventional
• Target: 2,972
• Locations: 1 country
• Sites: 1

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

Keywords

Venous Thromboembolism; Pulmonary Thromboembolisms; Digital Health

Outcome Measures

Primary Outcomes (1)

• VTE-related composite event

  The primary outcome was the occurrence of VTE-related composite event at 1-year follow-up, which was defined as a composite of recurrent VTE, newly diagnosed deep vein thrombosis (DVT), chronic thromboembolic pulmonary hypertension (CTEPH), major bleeding, VTE-related rehospitalization, and all-cause death.

  At 1-year follow-up

Secondary Outcomes (15)

• VTE events

  At 3, 6, 12, and 24-month follow-up

• Chronic thromboembolic pulmonary hypertension (CTEPH)

  At 3, 6, 12, and 24-month follow-up

• Chronic thromboembolic pulmonary disease (CTEPD)

  At 3, 6, 12, and 24-month follow-up

• Post-pulmonary embolism syndrome (PPES)

  At 3, 6, 12, and 24-month follow-up

• Major bleeding

  At 3, 6, 12, and 24-month follow-up

Study Arms (2)

mVTEA Management Group

EXPERIMENTAL

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

Other: mobile venous thromboembolism application (mVTEA)

Routine Management Group

NO INTERVENTION

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

Interventions

mobile venous thromboembolism application (mVTEA) 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.

mVTEA Management Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (1)

Sixth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100048, China

Location

Related Publications (2)

• 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.

  PMID: 35484821 BACKGROUND

• 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.

  PMID: 19878532 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• YU-TAO GUO, Doctor

  Sixth Medical Center of Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

ZHI-GENG JIN, Doctor

CONTACT

8615801402223; lwgjzg@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a multicenter, prospective, randomized controlled trial with a superiority design. Consecutively recruited patients with PTE will be randomly assigned in a 2:1 ratio to the interventive arm (mobile VTE application, mVTEA) and the usual care arm.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: October 8, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)