Smart Technology Facilitated Patient-centered Venous Thromboembolism Management (SmaVTE-RCT)

Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Randomised 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 venous thromboembolism (VTE) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with VTE.

Study Overview

• Status: Enrolling by invitation
• Conditions: Venous Thromboembolism; Health Education; Digital Health
• Intervention / Treatment: Other: mobile venous thromboembolism application (mVTEA)

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

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 ≥18 years of age at admission;
• Previous or current definitive diagnosis of DVT and/or PE by imaging, or 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:

• 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 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
Experimental: mVTEA Management Group; Patients randomly assigned to the mVTEA management group will be discharged with mVTEA-assisted patient-centered VTE 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 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, photo, and voice interactions.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VTE-KAP questionnaire score	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 will be evaluated at the third-month follow-up after discharge.	The third month after discharge from the hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VTE events	VTE events will be documented during the 3-month follow-up after discharge. VTE events are categorized into three groups: new-onset VTE, hospital-acquired VTE (HA-VTE), and recurrent 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. 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).	3 months after discharge
Chronic thromboembolic pulmonary hypertension (CTEPH)	The diagnosis of CTEPH will be documented at the third-month follow-up after discharge.	The third month after discharge
Chronic thromboembolic pulmonary disease (CTEPD)	The diagnosis of CTEPD will be documented at the third-month follow-up after discharge.	The third month after discharge
Post-pulmonary embolism syndrome (PPES)	The diagnosis of PPES will be documented at the third-month follow-up after discharge.	The third month after discharge
Major bleeding	The major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH) will be documented during the 3-month follow-up after discharge.	3 months after discharge
VTE-related hospitalization	Hospitalization due to the new-onset DVT and/or PE will be documented during the 3-month follow-up after discharge.	3 months after discharge
VTE-related rehospitalization	Rehospitalization due to VTE recurrence, progression, or complications related to VTE treatment will be documented during the 3-month follow-up after discharge.	3 months after discharge
New-onset of atrial fibrillation or atrial flutter	The new-onset of atrial fibrillation or atrial flutter will be documented during the 3-month follow-up after discharge.	3 months after discharge
Death	Death will be documented during the 3-month follow-up after discharge. 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.	3 months after discharge
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 the third-month follow-up 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.	The third month after discharge from the hospital
Knowledge, attitude, and practice scores in the VTE-KAP questionnaire	The knowledge domain contains 7 questions to assess patients' levels of knowledge regarding VTE prevention and treatment. The total score of knowledge for each study participant ranged from 7 to 53. The attitude domain contains 20 questions to assess patients' attitudes towards VTE prevention and treatment. Each question was scored and the final attitude score ranged between 20 and 100. The practice domain contained 26 questions with a score range of 21 to 130 for assessing the implementation of VTE prevention and treatment behaviors in the study patients. The higher the score, the higher the level of knowledge, attitude and practice. The patients' knowledge, attitude, and practice scores in the VTE-KAP questionnaire will be assessed at the third-month follow-up after discharge separately.	The third month after discharge from the hospital

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.
• Klok FA, Ageno W, Ay C, Back M, Barco S, Bertoletti L, Becattini C, Carlsen J, Delcroix M, van Es N, Huisman MV, Jara-Palomares L, Konstantinides S, Lang I, Meyer G, Ni Ainle F, Rosenkranz S, Pruszczyk P. Optimal follow-up after acute pulmonary embolism: a position paper of the European Society of Cardiology Working Group on Pulmonary Circulation and Right Ventricular Function, in collaboration with the European Society of Cardiology Working Group on Atherosclerosis and Vascular Biology, endorsed by the European Respiratory Society. Eur Heart J. 2022 Jan 25;43(3):183-189. doi: 10.1093/eurheartj/ehab816.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: March 30, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 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: Mobile Health; Venous Thromboembolism; Health Education; Prophylaxis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: HZKY-PJ-2024-8-1

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