Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism：A Multicenter, Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Navy General Hospital, Beijing
- Enrollment
- 2972
- Locations
- 1
- Primary Endpoint
- VTE-related composite event
- Status
- Not Yet Recruiting
- Last Updated
- 11 months ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
VTE-related composite event
Time Frame: 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.
Secondary Outcomes
- 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)