Smart Technology Facilitated Patient-centered Venous Thromboembolism Management

NCT ID: NCT06350344

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Thromboembolism Digital Health Health Education

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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mVTEA Management Group

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

Group Type EXPERIMENTAL

mobile venous thromboembolism application (mVTEA)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Navy General Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YU-TAO GUO, Doctor

Role: STUDY_CHAIR

Sixth Medical Center of Chinese PLA General Hospital

Locations

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Sixth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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ZHI-GENG JIN, Doctor

Role: CONTACT

8615801402223

References

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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.

Reference Type BACKGROUND
PMID: 18208538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22169121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32375490 (View on PubMed)

Other Identifiers

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HZKY-PJ-2024-8-2

Identifier Type: -

Identifier Source: org_study_id

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