Clinical trial NCT06350331: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management
Official title: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Venous Thromboembolism
Digital Health
Health Education
Keywords: Venous Thromboembolism
Mobile Health
Prophylaxis
Health Education
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 venous thromboembolism (VTE) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with VTE.


Eligibility criteria: Inclusion Criteria:

* Inpatients ≥18 years of age at admission;
* Previous or current definitive diagnosis of DVT and/or PE by imaging, or at high risk of VTE at discharge: Padua score ≥4 for medical patients and Caprini score ≥5 for surgical patients.
* Signed informed consent

Exclusion Criteria:

* Mental disorder or combination of other serious diseases leading to incapacity for independent living;
* 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-KAP questionnaire score
timeFrame: The third month after discharge from the hospital
Secondary outcomes:
measure: Knowledge, attitude, and practice scores in the VTE-KAP questionnaire
timeFrame: The third month after discharge from the hospital
measure: Generic quality of life
timeFrame: The third month after discharge from the hospital
measure: VTE events
timeFrame: 3 months after discharge
measure: Chronic thromboembolic pulmonary hypertension (CTEPH)
timeFrame: The third month after discharge
measure: Chronic thromboembolic pulmonary disease (CTEPD)
timeFrame: The third month after discharge
measure: Post-pulmonary embolism syndrome (PPES)
timeFrame: The third month after discharge
measure: Major bleeding
timeFrame: 3 months after discharge
measure: VTE-related hospitalization
timeFrame: 3 months after discharge
measure: VTE-related rehospitalization
timeFrame: 3 months after discharge
measure: New-onset of atrial fibrillation or atrial flutter
timeFrame: 3 months after discharge
measure: Death
timeFrame: 3 months after discharge
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: Klok FA, Ageno W, Ay C, Back M, Barco S, Bertoletti L, Becattini C, Carlsen J, Delcroix M, van Es N, Huisman MV, Jara-Palomares L, Konstantinides S, Lang I, Meyer G, Ni Ainle F, Rosenkranz S, Pruszczyk P. Optimal follow-up after acute pulmonary embolism: a position paper of the European Society of Cardiology Working Group on Pulmonary Circulation and Right Ventricular Function, in collaboration with the European Society of Cardiology Working Group on Atherosclerosis and Vascular Biology, endorsed by the European Respiratory Society. Eur Heart J. 2022 Jan 25;43(3):183-189. doi: 10.1093/eurheartj/ehab816.
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.