Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism：A Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,972
- 试验地点
- 2
- 主要终点
- VTE-related composite event
研究概览
简要总结
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.
This study aims to evaluate the effects of a smart technology-assisted, patient-centered mobile health application for pulmonary thromboembolism management (mPEA) on the long-term outcomes of patients with pulmonary thromboembolism (PTE). The findings are expected to inform clinical practice and provide an evidence base for the long-term management of patients with PTE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients aged ≥18 years;
- •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.
排除标准
- •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.
研究组 & 干预措施
Routine Management Group
Patients randomly assigned to the routine management group will be given routine post-discharge management in accordance with local clinical practice.
mPEA Management Group
Patients randomly assigned to the mPEA management group will be discharged with mPEA-assisted patient-centered PTE management.
干预措施: mobile venous thromboembolism application (mVTEA) (Other)
结局指标
主要结局
VTE-related composite event
时间窗: At 1-year follow-up
The primary outcome was the occurrence of VTE-related composite event at 1-year follow-up, which was defined as a composite of recurrent VTE, newly diagnosed deep vein thrombosis (DVT), chronic thromboembolic pulmonary hypertension (CTEPH), major bleeding, VTE-related rehospitalization, and all-cause death.
次要结局
- VTE events(At 3, 6, 12, and 24-month follow-up)
- Chronic thromboembolic pulmonary hypertension (CTEPH)(At 3, 6, 12, and 24-month follow-up)
- Chronic thromboembolic pulmonary disease (CTEPD)(At 3, 6, 12, and 24-month follow-up)
- Post-pulmonary embolism syndrome (PPES)(At 3, 6, 12, and 24-month follow-up)
- Major bleeding(At 3, 6, 12, and 24-month follow-up)
- VTE-related hospitalization(At 3, 6, 12, and 24-month follow-up)
- Death(At 3, 6, 12, and 24-month follow-up)
- Patient-Reported Outcome Events (PROs)(At 3, 6, 12, and 24-month follow-up)
- Anticoagulant adherence(At 3, 6, and 12-month follow-up)
- Probability of PTE progression(At 3, 6, and 12-month follow-up)
- Effectiveness evaluation(At 3, 6, and 12-month follow-up)
- Generic quality of life(At 6, 12, and 24-month follow-up)
- Costs of management for healthcare staff(At 3, 6, and 12-month follow-up)
- Treatment costs for VTE-related patients(At 1-year follow-up)
- Treatment costs for non-VTE-related patients(At 3, 6, and 12-month follow-up)