Smart Technology Facilitated Patient-centered Venous Thromboembolism Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mobile venous thromboembolism application (mVTEA).
- Who it may be relevant to
- Registry conditions: Venous Thromboembolism, Digital Health, Health Education. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Randomised Controlled Trial
Overview
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.
Interventions
- 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
Primary outcome measures
- VTE-KAP questionnaire score [Time frame: The third month after discharge from the hospital]
Secondary outcome measures (11)
- Knowledge, attitude, and practice scores in the VTE-KAP questionnaire [Time frame: The third month after discharge from the hospital]
- Generic quality of life [Time frame: The third month after discharge from the hospital]
- VTE events [Time frame: 3 months after discharge]
- Chronic thromboembolic pulmonary hypertension (CTEPH) [Time frame: The third month after discharge]
- Chronic thromboembolic pulmonary disease (CTEPD) [Time frame: The third month after discharge]
- Post-pulmonary embolism syndrome (PPES) [Time frame: The third month after discharge]
- Major bleeding [Time frame: 3 months after discharge]
- VTE-related hospitalization [Time frame: 3 months after discharge]
- VTE-related rehospitalization [Time frame: 3 months after discharge]
- New-onset of atrial fibrillation or atrial flutter [Time frame: 3 months after discharge]
- Death [Time frame: 3 months after discharge]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Sixth Medical Center of Chinese PLA General Hospital — Beijing
Publications
- 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 pulmona PMID 35484821
- 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 wi PMID 34875048
- 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.1538-7836.2 PMID 19878532
- 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
Identifiers
NCT: NCT06350331 · HZKY-PJ-2024-8-1