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Набор скоро начнётся NCT06382038

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

Без фазы С лечением Venous Thromboembolism Pulmonary Thromboembolisms Digital Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: mobile venous thromboembolism application (mVTEA).
Кому может быть актуально
Состояния в реестре: Venous Thromboembolism, Pulmonary Thromboembolisms, Digital Health. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

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 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 thei

Первичные конечные точки

  • VTE-related composite event [Срок оценки: At 1-year follow-up]
Вторичные конечные точки (12)
  • VTE events [Срок оценки: At 3, 6, 12, and 24-month follow-up]
  • Chronic thromboembolic pulmonary hypertension (CTEPH) [Срок оценки: At 3, 6, 12, and 24-month follow-up]
  • Chronic thromboembolic pulmonary disease (CTEPD) [Срок оценки: At 3, 6, 12, and 24-month follow-up]
  • Post-pulmonary embolism syndrome (PPES) [Срок оценки: At 3, 6, 12, and 24-month follow-up]
  • Major bleeding [Срок оценки: At 3, 6, 12, and 24-month follow-up]
  • VTE-related hospitalization [Срок оценки: At 3, 6, 12, and 24-month follow-up]
  • Death [Срок оценки: At 3, 6, 12, and 24-month follow-up]
  • Patient-Reported Outcome Events (PROs) [Срок оценки: At 3, 6, 12, and 24-month follow-up]
  • Generic quality of life [Срок оценки: At 6, 12, and 24-month follow-up]
  • Costs of management for healthcare staff [Срок оценки: At 3, 6, and 12-month follow-up]
  • Treatment costs for VTE-related patients [Срок оценки: At 1-year follow-up]
  • Treatment costs for non-VTE-related patients [Срок оценки: At 3, 6, and 12-month follow-up]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

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
  • 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

Идентификаторы

NCT: NCT06382038 · HZKY-PJ-2024-19

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗