Smart Technology Facilitated Patient-centered Venous Thromboembolism Management

NCT06350331 | Enrolling By Invitation DMC

• 1 other identifier: HZKY-PJ-2024-8-1
• Study Type: interventional
• Target: 256
• 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 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.

Conditions

Venous Thromboembolism; Digital Health; Health Education

Keywords

Venous Thromboembolism; Mobile Health; Prophylaxis; Health Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Knowledge, attitude, and practice scores in the VTE-KAP questionnaire

  The third month after discharge from the hospital

• Generic quality of life

  The third month after discharge from the hospital

• VTE events

  3 months after discharge

• Chronic thromboembolic pulmonary hypertension (CTEPH)

  The third month after discharge

• Chronic thromboembolic pulmonary disease (CTEPD)

  The third month after discharge

Study Arms (2)

mVTEA Management Group

EXPERIMENTAL

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

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 ≥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

You may not qualify if:

• 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.

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 (4)

• 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

• 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.

  PMID: 34875048 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

• Jin ZG, Zhang ZQ, Liu BB, Wang H, Yang Y, Ren LN, Zhang H, Ji W, Zhai ZG, Guo YT. Smart Technology Facilitated Patient-Centered Venous Thromboembolism Management (the SmaVTE Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 5;14:e67254. doi: 10.2196/67254.

  PMID: 40473232 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Health Education

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• YU-TAO GUO, Doctor

  Sixth Medical Center of Chinese PLA General Hospital

  STUDY CHAIR

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

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 5, 2024
• Study Start: August 17, 2024
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)