Smart Technology Facilitated Patient-centered Venous Thromboembolism Management

NCT06350344 | Not Yet Recruiting DMC

• 1 other identifier: HZKY-PJ-2024-8-2
• Study Type: interventional
• Target: 2,353
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism; Digital Health; Health Education

Keywords

Venous Thromboembolism; Mobile Health; Prophylaxis; Health Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• VTE-KAP questionnaire score

  At 3, 12, and 24-month follow-up

• Generic quality of life

  At 3, 12, and 24-month follow-up

• VTE events

  At 3, 6, 12, and 24-month follow-up

• Major bleeding

  At 3, 6, 12, and 24-month follow-up

• VTE-related hospitalization

  At 3, 6, 12, and 24-month follow-up

Study Arms (1)

mVTEA Management Group

EXPERIMENTAL

Patients with high-risk of VTE will be discharged with mVTEA-assisted patient-centered VTE management.

Device: mobile venous thromboembolism application (mVTEA)

Interventions

mobile venous thromboembolism application (mVTEA) DEVICE

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.

mVTEA Management Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Study Sites (1)

Sixth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100048, China

Location

Related 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.

  PMID: 18208538 BACKGROUND

• 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.

  PMID: 22169121 BACKGROUND

• 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.

  PMID: 32375490 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Health Education

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• YU-TAO GUO, Doctor

  Sixth Medical Center of Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

ZHI-GENG JIN, Doctor

CONTACT

8615801402223; lwgjzg@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)