Clinical trial NCT06350344: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management
Official title: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Multicenter Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
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: 2353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 observe the long-term effect of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on thromboprophylaxis, and establish a foundation of evidence for managing patients with high-risk VTE.


Eligibility criteria: Inclusion Criteria:

* Inpatients ≥18 years of age at admission;
* 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:

* Diagnosis of VTE at discharge;
* 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-related composite event
timeFrame: At 1-year follow-up
Secondary outcomes:
measure: VTE-KAP questionnaire score
timeFrame: At 3, 12, and 24-month follow-up
measure: Generic quality of life
timeFrame: At 3, 12, and 24-month follow-up
measure: VTE events
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: New-onset of atrial fibrillation or atrial flutter
timeFrame: At 3, 6, 12, and 24-month follow-up
measure: Death
timeFrame: At 3, 6, 12, and 24-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: Chew HK, Davies AM, Wun T, Harvey D, Zhou H, White RH. The incidence of venous thromboembolism among patients with primary lung cancer. J Thromb Haemost. 2008 Apr;6(4):601-8. doi: 10.1111/j.1538-7836.2008.02908.x. Epub 2008 Jan 17.
citation: Kang MJ, Ryoo BY, Ryu MH, Koo DH, Chang HM, Lee JL, Kim TW, Kang YK. Venous thromboembolism (VTE) in patients with advanced gastric cancer: an Asian experience. Eur J Cancer. 2012 Mar;48(4):492-500. doi: 10.1016/j.ejca.2011.11.016. Epub 2011 Dec 12.
citation: Henke PK, Kahn SR, Pannucci CJ, Secemksy EA, Evans NS, Khorana AA, Creager MA, Pradhan AD; American Heart Association Advocacy Coordinating Committee. Call to Action to Prevent Venous Thromboembolism in Hospitalized Patients: A Policy Statement From the American Heart Association. Circulation. 2020 Jun 16;141(24):e914-e931. doi: 10.1161/CIR.0000000000000769. Epub 2020 May 7.