Smart Technology Facilitated Patient-centered Venous Thromboembolism Management

Venous Thromboembolism Clinical Trial

— SmaVTE-COR  

Official title:

Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Multicenter Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06350344
• Other study ID #: HZKY-PJ-2024-8-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: October 31, 2027

Study information

• Verified date: March 2024
• Source: Navy General Hospital, Beijing
• Contact: ZHI-GENG JIN, Doctor
• Phone: 8615801402223
• Email: lwgjzg[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2353
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Digital Health
• Health Education
• Thromboembolism
• Venous Thromboembolism

Intervention

Device:
• mobile venous thromboembolism application (mVTEA)
mVTEA will assist in the management of patients with high-risk of VTE during the post-hospitalization follow-up phase. The mVTEA's doctor terminal automatically sends 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 their condition. This can be done through the mVTEA doctor-patient communication module, which includes text, voice, and video communication.

Locations

Country	Name	City	State
China	Sixth Medical Center of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. Erratum In: Circulation. 2020 Jun 16;141(24):e932. Circulation. 2021 Feb 16;143(7):e249. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE-related composite event	The primary outcome was the occurrence of VTE-related composite event at 1-year follow-up, which was defined as a composite of VTE, major bleeding, VTE-related hospitalization, and all-cause death.	At 1-year follow-up
Secondary	VTE-KAP questionnaire score	The VTE-KAP questionnaire is a self-administered questionnaire that includes demographic characteristics, knowledge, attitude, and practice (KAP) of patients towards VTE prevention and treatment. The VTE-KAP questionnaire consists of a total of 54 questions with an overall score range of 49 to 291. The higher the score, the higher the level of knowledge, attitude, and practice. The VTE-KAP questionnaire scores of the patients regarding the prevention and treatment of VTE will be evaluated at 3, 12, and 24-month follow-up.	At 3, 12, and 24-month follow-up
Secondary	Generic quality of life	Generic, non-disease-speci?c health-related quality of life (QoL) is assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire and its corresponding visual analogue scale at 3, 12, and 24-month follow-up. Brie?y, the EQ-5D-5L generates an overall index that ranges from 0 (lowest generic QoL) to 1 (highest generic QoL) and is calculated based on country-speci?c reference value sets. The EQ-5D-5L health index was calculated with the value set for China. The EuroQol visual analogue scale ranges from 0 to 100, with higher scores indicating better health.	At 3, 12, and 24-month follow-up
Secondary	VTE events	VTE events will be documented during the follow-up. VTE events are categorized into two groups: new-onset VTE, and hospital-acquired VTE (HA-VTE).; VTE that occurred for the first time during the study period, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is classified as new-onset VTE.; HA-VTE is defined as any new-onset VTE that has occurred within 90 days of hospital discharge.	At 3, 6, 12, and 24-month follow-up
Secondary	Major bleeding	The major bleeding events as defined by the International Society on Thrombosis and Hemostasis (ISTH) will be documented during the follow-up.	At 3, 6, 12, and 24-month follow-up
Secondary	VTE-related hospitalization	Hospitalization due to the new-onset DVT and/or PE will be documented during the follow-up.	At 3, 6, 12, and 24-month follow-up
Secondary	New-onset of atrial fibrillation or atrial flutter	The new-onset of atrial fibrillation or atrial flutter will be documented during the follow-up.	At 3, 6, 12, and 24-month follow-up
Secondary	Death	Death will be documented during the follow-up. It is categorized into all-cause death and PE-related death. All-cause death is defined as death that occurs during the study period, regardless of cause.PE-related death is defined as death that is unequivocally due to PE.	At 3, 6, 12, and 24-month follow-up