Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism
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, Pulmonary Thromboembolisms, Digital Health. 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 Care for Patients With Pulmonary Thromboembolism：A Multicenter, Randomized 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 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.
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 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
Primary outcome measures
- VTE-related composite event [Time frame: At 1-year follow-up]
Secondary outcome measures (12)
- VTE events [Time frame: At 3, 6, 12, and 24-month follow-up]
- Chronic thromboembolic pulmonary hypertension (CTEPH) [Time frame: At 3, 6, 12, and 24-month follow-up]
- Chronic thromboembolic pulmonary disease (CTEPD) [Time frame: At 3, 6, 12, and 24-month follow-up]
- Post-pulmonary embolism syndrome (PPES) [Time frame: At 3, 6, 12, and 24-month follow-up]
- Major bleeding [Time frame: At 3, 6, 12, and 24-month follow-up]
- VTE-related hospitalization [Time frame: At 3, 6, 12, and 24-month follow-up]
- Death [Time frame: At 3, 6, 12, and 24-month follow-up]
- Patient-Reported Outcome Events (PROs) [Time frame: At 3, 6, 12, and 24-month follow-up]
- Generic quality of life [Time frame: At 6, 12, and 24-month follow-up]
- Costs of management for healthcare staff [Time frame: At 3, 6, and 12-month follow-up]
- Treatment costs for VTE-related patients [Time frame: At 1-year follow-up]
- Treatment costs for non-VTE-related patients [Time frame: At 3, 6, and 12-month follow-up]
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.
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
- 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
Identifiers
NCT: NCT06382038 · HZKY-PJ-2024-19