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

Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism：A Multicenter, Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Venous Thromboembolism; Digital Health; Pulmonary Thromboembolisms
• Intervention / Treatment: Other: mobile venous thromboembolism application (mVTEA)

• Study Type: Interventional
• Enrollment (Estimated): 2972
• Phase: Not Applicable

Contacts and Locations

• 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

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Management Group; Patients randomly assigned to the routine management group will be given routine post-discharge management in accordance with local clinical practice.
Experimental: mVTEA Management Group; Patients randomly assigned to the mVTEA management group will be discharged with mVTEA-assisted patient-centered PTE management.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
VTE events	VTE events will be documented at the 3, 6, 12, and 24-month follow-up after discharge. VTE events are categorized into two groups: recurrent VTE and newly diagnosed DVT. Recurrent VTE is defined as the appearance of new evidence of VTE after acute VTE has been treated in the acute phase (2 weeks) with significant clinical improvement in signs and symptoms. According to the time of VTE recurrence, it is further categorized into early VTE recurrence (within 3 months after the last VTE occurrence) and late VTE recurrence (more than 3 months after the last VTE occurrence). DVT that occurred for the first time after discharge during the study period is classified as newly diagnosed DVT.	At 3, 6, 12, and 24-month follow-up
Chronic thromboembolic pulmonary hypertension (CTEPH)	The diagnosis of CTEPH will be documented at the 3, 6, 12, and 24-month follow-up.	At 3, 6, 12, and 24-month follow-up
Chronic thromboembolic pulmonary disease (CTEPD)	The diagnosis of CTEPD will be documented at the 3, 6, 12, and 24-month follow-up after discharge.	At 3, 6, 12, and 24-month follow-up
Post-pulmonary embolism syndrome (PPES)	The diagnosis of PPES will be documented at the 3, 6, 12, and 24-month follow-up after discharge	At 3, 6, 12, and 24-month follow-up
Major bleeding	The major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH) will be documented at the 3, 6, 12, and 24-month follow-up after discharge.	At 3, 6, 12, and 24-month follow-up
VTE-related hospitalization	Rehospitalization due to VTE recurrence, progression, or complications related to VTE treatment will be documented during the follow-up.	At 3, 6, 12, and 24-month follow-up
Death	Death will be documented during the follow-up. It is categorized into all-cause death and PTE-related death. All-cause death is defined as death that occurs during the study period, regardless of cause. PTE-related death is defined as death that is unequivocally due to PTE.	At 3, 6, 12, and 24-month follow-up
Patient-Reported Outcome Events (PROs)	PROs will be documented during the 3, 6, 12, and 24-month follow-up after discharge. PROs refer to information directly conveyed by patients themselves concerning their health status, symptoms, functional capacity, or adverse events related to treatment, without the need for interpretation or mediation by clinicians or other third parties.	At 3, 6, 12, and 24-month follow-up
Generic quality of life	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 6, 12, and 24 months after discharge. 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 6, 12, and 24-month follow-up
Costs of management for healthcare staff	Costs of healthcare staff training (training duration × hourly wage), including training on standardized management of pulmonary embolism and the use of mVTEA; costs associated with post-discharge patient management by healthcare personnel (such as follow-up management, rehabilitation management, health counseling, and comorbidity management), calculated as (consultation time/re-hospitalization time × hourly wage); and development costs for mobile technology and intelligent algorithms.	At 3, 6, and 12-month follow-up
Treatment costs for VTE-related patients	Treatment costs for VTE-related patients within 12 months post-discharge: These include registration fees, diagnostic costs, and treatment expenses incurred during visits to community clinics, hospital emergency departments, or specialist outpatient clinics due to changes in PTE condition (such as VTE recurrence, newly diagnosed DVT, bleeding, CTEPH, CTEPD, or PPES). They also encompass diagnostic and treatment expenses during hospital admissions in community or specialist settings due to changes in PTE condition. Additionally, costs arising from routine VTE follow-ups (without any changes in VTE-related conditions) at community clinics, hospital emergency departments, or specialist outpatient clinics are included.	At 1-year follow-up
Treatment costs for non-VTE-related patients	Treatment costs for non-VTE-related patients within 12 months post-discharge: These comprise registration fees, diagnostic costs, and treatment expenses associated with visits to community clinics, hospital emergency departments, or specialist outpatient clinics for non-VTE-related conditions, as well as diagnostic and treatment expenses during hospital admissions in community or specialist settings for non-VTE-related diseases.	At 3, 6, and 12-month follow-up
Anticoagulant adherence	Adherence would be assessed at months 3, 6, and 12 after discharge (defined as: the number of patients taking anticoagulants as prescribed/total number of patients at follow-up time point × 100%).	At 3, 6, and 12-month follow-up
Probability of PTE progression	Clinical cure rate of PTE (defined as the numbers of patients without VTE recurrence, newly diagnosed DVT, bleeding, CTEPH, CTEPD, PPES, or all-cause mortality / total number of patients at the follow-up time point × 100% ); VTE (PTE/DVT) recurrence rate; incidence rate of newly diagnosed DVT; bleeding incidence rate; major bleeding incidence rate; non-major bleeding incidence rate; CTEPH incidence rate; CTEPD incidence rate; PPES incidence rate; all-cause mortality rate; PTE-related mortality rate would be collected.	At 3, 6, and 12-month follow-up
Effectiveness evaluation	Quality-Adjusted Life Year(QALY) with EQ-5D-5L questionnaire would be investigated at 3, 6, and 12 months post-discharge and when the occurrence of VTE-related adverse events, including newly diagnosed DVT, bleeding, CTEPH, CTEPD, PPES, or all-cause mortality.	At 3, 6, and 12-month follow-up

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 8, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Venous Thromboembolism; Digital Health; Pulmonary Thromboembolisms
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: HZKY-PJ-2024-19

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
• product manufactured in and exported from the U.S.: No