Smart Technology Facilitated Patient-centered Venous Thromboembolism Management

Официальное название

Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Randomised Controlled Trial

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• VTE-KAP questionnaire score [Срок оценки: The third month after discharge from the hospital]

Вторичные конечные точки (11)

• Knowledge, attitude, and practice scores in the VTE-KAP questionnaire [Срок оценки: The third month after discharge from the hospital]
• Generic quality of life [Срок оценки: The third month after discharge from the hospital]
• VTE events [Срок оценки: 3 months after discharge]
• Chronic thromboembolic pulmonary hypertension (CTEPH) [Срок оценки: The third month after discharge]
• Chronic thromboembolic pulmonary disease (CTEPD) [Срок оценки: The third month after discharge]
• Post-pulmonary embolism syndrome (PPES) [Срок оценки: The third month after discharge]
• Major bleeding [Срок оценки: 3 months after discharge]
• VTE-related hospitalization [Срок оценки: 3 months after discharge]
• VTE-related rehospitalization [Срок оценки: 3 months after discharge]
• New-onset of atrial fibrillation or atrial flutter [Срок оценки: 3 months after discharge]
• Death [Срок оценки: 3 months after discharge]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Sixth Medical Center of Chinese PLA General Hospital — Пекин

Публикации

• 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

Идентификаторы

NCT: NCT06350331 · HZKY-PJ-2024-8-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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