Clinical trial NCT06382038: Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism
Official title: Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism：A Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Venous Thromboembolism
Pulmonary Thromboembolisms
Digital Health
Keywords: Venous Thromboembolism
Pulmonary Thromboembolisms
Digital Health
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 2972
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a multicenter, prospective, randomized controlled trial with a superiority design. Consecutively recruited patients with PTE will be randomly assigned in a 2:1 ratio to the interventive arm (mobile VTE application, mVTEA) and the usual care arm.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: VTE-related composite event
timeFrame: At 1-year follow-up
Secondary outcomes:
measure: VTE events
timeFrame: At 3, 6, 12, and 24-month follow-up
measure: Chronic thromboembolic pulmonary hypertension (CTEPH)
timeFrame: At 3, 6, 12, and 24-month follow-up
measure: Chronic thromboembolic pulmonary disease (CTEPD)
timeFrame: At 3, 6, 12, and 24-month follow-up
measure: Post-pulmonary embolism syndrome (PPES)
timeFrame: At 3, 6, 12, and 24-month follow-up
measure: Major bleeding
timeFrame: At 3, 6, 12, and 24-month follow-up
measure: VTE-related hospitalization
timeFrame: At 3, 6, 12, and 24-month follow-up
measure: Death
timeFrame: At 3, 6, 12, and 24-month follow-up
measure: Patient-Reported Outcome Events (PROs)
timeFrame: At 3, 6, 12, and 24-month follow-up
measure: Generic quality of life
timeFrame: At 6, 12, and 24-month follow-up
measure: Costs of management for healthcare staff
timeFrame: At 3, 6, and 12-month follow-up
measure: Treatment costs for VTE-related patients
timeFrame: At 1-year follow-up
measure: Treatment costs for non-VTE-related patients
timeFrame: At 3, 6, and 12-month follow-up
measure: Anticoagulant adherence
timeFrame: At 3, 6, and 12-month follow-up
measure: Probability of PTE progression
timeFrame: At 3, 6, and 12-month follow-up
measure: Effectiveness evaluation
timeFrame: At 3, 6, and 12-month follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sixth Medical Center of Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Sixth Medical Center of Chinese PLA General Hospital
name: YU-TAO GUO, Doctor
role: STUDY_CHAIR
References:
citation: 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 pulmonary hypertension and impairment after pulmonary embolism: the FOCUS study. Eur Heart J. 2022 Sep 21;43(36):3387-3398. doi: 10.1093/eurheartj/ehac206.
citation: 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.1538-7836.2009.03678.x. Epub 2009 Oct 30.